xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06002321</url>
    </required_header>
    <id_info>
      <org_study_id>RIVED - CHF</org_study_id>
      <nct_id>NCT06002321</nct_id>
    </id_info>
    <brief_title>Right Ventricular Dysfunction in Chronic Heart Failure</brief_title>
    <acronym>RIVED-CHF</acronym>
    <official_title>Right Ventricular Dysfunction in Chronic Heart Failure: Clinical Laboratory and Echocardiographic Characteristics</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Siena</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Italian Society of Cardiology</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Siena</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this multi center observational prospective study is to analyze the concordance&#xD;
        between the signs and symptoms of RHF and echocardiographic features of RVD in patient with&#xD;
        heart failure. The main questions it aims to answer are:&#xD;
  &#xD;
          1. to assess the incidence of RVH and RVD in each HF subtypes.&#xD;
  &#xD;
          2. to evaluate prognostic impact ( in terms of cardiovascular mortality and HF&#xD;
             hospitalization) of different RVD patterns during a mean followup period of 3 years&#xD;
  &#xD;
          3. To investigate the incidence of different RV maladaptation ( isolated RV dilatation,&#xD;
             isolated Pulmonary hypertension, combined pattern) in each HF groups and the related&#xD;
             outcome.&#xD;
  &#xD;
        Participants will follow by direct check up visit and/or virtual visits every 6 months for a&#xD;
        mean follow-up period of 3 years.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Right ventricular dysfunction (RVD) and pulmonary hypertension (PH) have been recognized as&#xD;
        two important prognostic features in patients with left side heart failure (HF). Nevertheless&#xD;
        literature does not distinguish between right heart failure (RHF) and RVD, and the two terms&#xD;
        are indifferently employed to describe PH and impaired RV performance. This is a multicenter&#xD;
        observational prospective study endorsed by the Italian Society of Cardiology that would&#xD;
        analyse the concordance between the signs and symptoms of RHF and echocardiographic features&#xD;
        of RVD. Therefore the right ventricle (RV) adaptation across different left ventricular&#xD;
        ejection fraction (LVEF) values, is poorly investigated. According to the recent heart&#xD;
        failure (HF) guidelines classified patients based on LVEF in HF with preserved ( HFpEF) mild&#xD;
        reduced (HFmEF) and reduced LVEF ( HFrEF), the investigators would assess by seral clinical&#xD;
        laboratory and detailed echocardiographic study all patients affected by chronic HF&#xD;
        regardless LVEF threshold in stable condition and will follow by direct check up visit and/or&#xD;
        virtual visits every 6 months for a mean follow-up period of 3 years. All clinical laboratory&#xD;
        and echocardiographic data will be recorded in a web platform system accessible for all&#xD;
        center included in the study The main aims of the study are; 1- to assess the incidence of&#xD;
        RVH and RVD in each HF subtypes. 2- to evaluate prognostic impact ( in terms of&#xD;
        cardiovascular mortality and HF hospitalization) of different RVD patterns during a mean&#xD;
        followup period of 3 years 3- To investigate the incidence of different RV maladaptation (&#xD;
        isolated RV dilatation, isolated Pulmonary hypertension, combined pattern) in each HF groups&#xD;
        and the related outcome. The investigators expect to find different RVD degree and severity&#xD;
        according to the type of left HF and its severity. Additionally, by a serial multiparametric&#xD;
        analysis of RV, it would be possible to establish the stage and type of RVD and consequent&#xD;
        concordance with signs of RHF.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">March 1, 2024</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>36 Months</target_duration>
    <primary_outcome>
      <measure>Different patterns of RVD in chronic heart failure.</measure>
      <time_frame>6 months.</time_frame>
      <description>The different patterns of RVD will be evaluated with echocardiographic measurements. Right ventricular function will be assessed by the following echocardiographic parameters: tricuspid annular plane excursion (TAPSE) and right ventricular fractional area change (RVFAC).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Analyze the incidence and prevalence of RVD and RHF.</measure>
      <time_frame>6 months.</time_frame>
      <description>To analyze the incidence and prevalence of RVD and RHF according to left ventricular ejection fraction (HFrEF, HFmrEF, HFpEF).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Compare the clinical signs of right heart failure with the echocardiographic signs of RVD.</measure>
      <time_frame>6 months.</time_frame>
      <description>Compare clinical signs of right heart failure with echocardiographic parameters of right ventricular dysfunction in order to verify agreement and identify a precise relationship between RHF and RVD.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Define the incidence of RVD.</measure>
      <time_frame>6 months.</time_frame>
      <description>To define the incidence of RVD through a multiparametric echocardiographic analysis including all the echocardiographic parameters of right ventricular function in order to identify a precise score based on the simultaneous dysfunction of several parameters.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Investigate a correlation between the different parameters.</measure>
      <time_frame>6 months.</time_frame>
      <description>Investigate a correlation between echo parameters, clinical signs and laboratory data.</description>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">1000</enrollment>
    <condition>Chronic Heart Failure</condition>
    <condition>Right Ventricular Dysfunction</condition>
    <condition>Right Heart Failure</condition>
    <arm_group>
      <arm_group_label>HFpEF</arm_group_label>
      <description>The HFpEF group includes patients with signs and/or symptoms of heart failure and LVEF &gt; 50% and objective evidence of structural and/or functional cardiac abnormalities consistent with the presence of LV diastolic dysfunction/raised LV filling pressures, including raised natriuretic peptides.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>HFmrEF</arm_group_label>
      <description>The HFmrEF group includes patients with signs and/or symptoms of heart failure and LVEF 41-49%.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>HFrEF</arm_group_label>
      <description>The HFrEF group includes patients with signs and/or symptoms of heart failure and LVEF &lt; 40%.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Echocardiography</intervention_name>
      <description>Patients will undergo echocardiographic examination. The ejection fraction will be calculated using Simpson's method. The E/e' ratio will be measured using the Doppler method. E/e' &gt; 13 will be considered an expression of the increase in LVFP. TAPSE will be measured together with the peak tricuspid regurgitation velocity (TVR). Pulmonary arterial hypertension will be defined as TVR &gt; 2.8 m/s. Estimation of right atrial pressure (eRAP) will be obtained based on the diameter and inspiratory collapsibility of the inferior vena cava.</description>
      <arm_group_label>HFmrEF</arm_group_label>
      <arm_group_label>HFpEF</arm_group_label>
      <arm_group_label>HFrEF</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Laboratory Test</intervention_name>
      <description>BNP, NT-proBNP and renal function.</description>
      <arm_group_label>HFmrEF</arm_group_label>
      <arm_group_label>HFpEF</arm_group_label>
      <arm_group_label>HFrEF</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          All patients with chronic heart failure will be consecutively enrolled prospectively in&#xD;
          different cities. The diagnosis will be made on the basis of the signs and symptoms of the&#xD;
          disease associated with BNP and NT-proBNP levels. Patients will be classified according to&#xD;
          the type of cardiac structure and remodeling defect and ejection fraction.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All patients with a diagnosis of chronic heart failure made according to the&#xD;
               recommendations of the ESC guidelines through the simultaneous presence of signs and&#xD;
               symptoms of disease associated with BNP and NT proBNP levels &gt; 100 and 300 pg/ml&#xD;
               respectively which are associated with a modest increase PAPS &gt; 30 mmHg with or&#xD;
               without right ventricular dilatation.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with dyspnea of non-cardiogenic origin, related to systemic respiratory&#xD;
               diseases, pulmonary embolism, patients with primary pulmonary hypertension will be&#xD;
               excluded.&#xD;
  &#xD;
            -  Patients with heart failure linked to primary valvular pathologies or infiltrative&#xD;
               pathologies, secondary and on a genetic basis, patients diagnosed with acute heart&#xD;
               failure in non-optimized therapy for at least 3 months will also be excluded. -&#xD;
               Patients with systemic inflammatory neoplastic diseases, advanced liver and kidney&#xD;
               diseases awaiting transplantation will be excluded.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Alberto Palazzuoli, MD</last_name>
      <role>Study Director</role>
      <affiliation>Unità di Malattie Cardiovascolari, Dipartimento Cardio-Toraco-Vascolare AOUS, Siena</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Alberto Palazzuoli, MD</last_name>
      <phone>+390577585363</phone>
      <email>palazzuoli2@unisi.it</email>
    </overall_contact>
    <location>
      <facility>
        <name>Centro Cardiologico Monzino</name>
        <address>
          <city>Milan</city>
          <state>Milano</state>
          <zip>20138</zip>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Pier Giuseppe Agostoni, MD</last_name>
        <email>piergiuseppe.agostoni@unimi.it</email>
      </contact>
      <investigator>
        <last_name>Pier Giuseppe Agostoni, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Department of Medicine, Surgery and Dentistry, Università di Salerno</name>
        <address>
          <city>Fisciano</city>
          <state>Salerno</state>
          <zip>84084</zip>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Michele Ciccarelli, MD</last_name>
        <email>mciccarelli@unisa.it</email>
      </contact>
      <investigator>
        <last_name>Michele Ciccarelli, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>SC Universitaria di Cardiologia - UTIC Policlinico Riuniti Foggia</name>
        <address>
          <city>Foggia</city>
          <zip>71121</zip>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Michele Correale, MD</last_name>
        <email>michele.correale@libero.it</email>
      </contact>
      <investigator>
        <last_name>Michele Correale, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Department of Clinical and Experimental Medicine, Operativee Unit of Cardiology, University of Messina</name>
        <address>
          <city>Messina</city>
          <zip>98125</zip>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Giuseppe Dattilo, MD</last_name>
        <email>dattimed@hotmail.it</email>
      </contact>
      <investigator>
        <last_name>Giuseppe Dattilo, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Ospedale Sant'Agostino Milano</name>
        <address>
          <city>Milano</city>
          <zip>20127</zip>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Frank Dini, MD</last_name>
        <email>franklloyddini@gmail.com</email>
      </contact>
      <investigator>
        <last_name>Frank Dini, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Department of Translational Medical Sciences, CIRCET</name>
        <address>
          <city>Napoli</city>
          <zip>80131</zip>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Gabriele Tocchetti, MD</last_name>
      </contact>
      <investigator>
        <last_name>Gabriele Tocchetti, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Department of Translational Medical Sciences, Federico II University, CIRCET</name>
        <address>
          <city>Napoli</city>
          <zip>80131</zip>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Valentina Mercurio, MD</last_name>
      </contact>
      <investigator>
        <last_name>Valentina Mercurio, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Heart Failure Unit, Department of Cardiology, AORN dei Colli-Monaldi</name>
        <address>
          <city>Napoli</city>
          <zip>80131</zip>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Daniele Masarone, MD</last_name>
        <email>danielemasarone@gmail.com</email>
      </contact>
      <investigator>
        <last_name>Daniele Masarone, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Fondazione IRCCS Policlinico San Matteo - Pavia UOC Cardiologia 1</name>
        <address>
          <city>Pavia</city>
          <zip>27100</zip>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Stefano Ghio, MD</last_name>
        <email>s.ghio@smatteo.pv.it</email>
      </contact>
      <investigator>
        <last_name>Stefano Ghio, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>S. Maria della Misericordia Hospital</name>
        <address>
          <city>Perugia</city>
          <zip>06100</zip>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Erberto Carluccio, MD</last_name>
        <email>erberto.carluccio@unipg.it</email>
      </contact>
      <investigator>
        <last_name>Erberto Carluccio, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>SC Cardiologia, Azienda Ospedaliera Ospedale San Carlo Potenza</name>
        <address>
          <city>Potenza</city>
          <zip>85100</zip>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Pietro Mazzeo, MD</last_name>
        <email>pietromazzeo91@tiscali.it</email>
      </contact>
      <investigator>
        <last_name>Pietro Mazzeo, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Cardiology, Department of Clinica, Internal, Anesthesiology and Cardiovascular Scienses, Sapienza.</name>
        <address>
          <city>Roma</city>
          <zip>00161</zip>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Paolo Severino, MD</last_name>
        <email>paolo.severino@uniroma1.it</email>
      </contact>
      <investigator>
        <last_name>Paolo Severino, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Cardiology, Department of Clinica, Internal, Anesthesiology and Cardiovascular Scienses.</name>
        <address>
          <city>Roma</city>
          <zip>00161</zip>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Roberto Badagliaca, MD</last_name>
        <email>roberto.badagliacca@uniroma1.it</email>
      </contact>
      <investigator>
        <last_name>Roberto Badagliacca, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Unità di Malattie Cardiovascolari, Dipartimento Cardio-Toraco-Vascolare AOUS, Università degli Studi, Siena.</name>
        <address>
          <city>Siena</city>
          <zip>53100</zip>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Alberto Palazzuoli, MD</last_name>
        <email>palazzuoli2@unisi.it</email>
      </contact>
      <investigator>
        <last_name>Alberto Palazzuoli, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
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      <citation>Guazzi M, Borlaug BA. Pulmonary hypertension due to left heart disease. Circulation. 2012 Aug 21;126(8):975-90. doi: 10.1161/CIRCULATIONAHA.111.085761. No abstract available.</citation>
      <PMID>22908015</PMID>
    </reference>
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      <citation>Konstam MA, Kiernan MS, Bernstein D, Bozkurt B, Jacob M, Kapur NK, Kociol RD, Lewis EF, Mehra MR, Pagani FD, Raval AN, Ward C; American Heart Association Council on Clinical Cardiology; Council on Cardiovascular Disease in the Young; and Council on Cardiovascular Surgery and Anesthesia. Evaluation and Management of Right-Sided Heart Failure: A Scientific Statement From the American Heart Association. Circulation. 2018 May 15;137(20):e578-e622. doi: 10.1161/CIR.0000000000000560. Epub 2018 Apr 12.</citation>
      <PMID>29650544</PMID>
    </reference>
    <reference>
      <citation>Puwanant S, Priester TC, Mookadam F, Bruce CJ, Redfield MM, Chandrasekaran K. Right ventricular function in patients with preserved and reduced ejection fraction heart failure. Eur J Echocardiogr. 2009 Aug;10(6):733-7. doi: 10.1093/ejechocard/jep052. Epub 2009 May 13.</citation>
      <PMID>19443468</PMID>
    </reference>
    <reference>
      <citation>Barilli M, Tavera MC, Valente S, Palazzuoli A. Structural and Hemodynamic Changes of the Right Ventricle in PH-HFpEF. Int J Mol Sci. 2022 Apr 20;23(9):4554. doi: 10.3390/ijms23094554.</citation>
      <PMID>35562945</PMID>
    </reference>
    <reference>
      <citation>Dini FL, Pugliese NR, Ameri P, Attanasio U, Badagliacca R, Correale M, Mercurio V, Tocchetti CG, Agostoni P, Palazzuoli A; Heart Failure Study Group of the Italian Society of Cardiology. Right ventricular failure in left heart disease: from pathophysiology to clinical manifestations and prognosis. Heart Fail Rev. 2023 Jul;28(4):757-766. doi: 10.1007/s10741-022-10282-2. Epub 2022 Oct 26.</citation>
      <PMID>36284079</PMID>
    </reference>
    <reference>
      <citation>Schmeisser A, Rauwolf T, Groscheck T, Kropf S, Luani B, Tanev I, Hansen M, Meissler S, Steendijk P, Braun-Dullaeus RC. Pressure-volume loop validation of TAPSE/PASP for right ventricular arterial coupling in heart failure with pulmonary hypertension. Eur Heart J Cardiovasc Imaging. 2021 Jan 22;22(2):168-176. doi: 10.1093/ehjci/jeaa285.</citation>
      <PMID>33167032</PMID>
    </reference>
    <reference>
      <citation>Guazzi M, Bandera F, Pelissero G, Castelvecchio S, Menicanti L, Ghio S, Temporelli PL, Arena R. Tricuspid annular plane systolic excursion and pulmonary arterial systolic pressure relationship in heart failure: an index of right ventricular contractile function and prognosis. Am J Physiol Heart Circ Physiol. 2013 Nov 1;305(9):H1373-81. doi: 10.1152/ajpheart.00157.2013. Epub 2013 Aug 30.</citation>
      <PMID>23997100</PMID>
    </reference>
    <reference>
      <citation>Guazzi M, Dixon D, Labate V, Beussink-Nelson L, Bandera F, Cuttica MJ, Shah SJ. RV Contractile Function and its Coupling to Pulmonary Circulation in Heart Failure With Preserved Ejection Fraction: Stratification of Clinical Phenotypes and Outcomes. JACC Cardiovasc Imaging. 2017 Oct;10(10 Pt B):1211-1221. doi: 10.1016/j.jcmg.2016.12.024. Epub 2017 Apr 12.</citation>
      <PMID>28412423</PMID>
    </reference>
    <reference>
      <citation>Gheorghiade M, Follath F, Ponikowski P, Barsuk JH, Blair JE, Cleland JG, Dickstein K, Drazner MH, Fonarow GC, Jaarsma T, Jondeau G, Sendon JL, Mebazaa A, Metra M, Nieminen M, Pang PS, Seferovic P, Stevenson LW, van Veldhuisen DJ, Zannad F, Anker SD, Rhodes A, McMurray JJ, Filippatos G; European Society of Cardiology; European Society of Intensive Care Medicine. Assessing and grading congestion in acute heart failure: a scientific statement from the acute heart failure committee of the heart failure association of the European Society of Cardiology and endorsed by the European Society of Intensive Care Medicine. Eur J Heart Fail. 2010 May;12(5):423-33. doi: 10.1093/eurjhf/hfq045. Epub 2010 Mar 30.</citation>
      <PMID>20354029</PMID>
    </reference>
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      <citation>McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available. Erratum In: Eur Heart J. 2021 Oct 14;:</citation>
      <PMID>34447992</PMID>
    </reference>
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      <citation>Lang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, Flachskampf FA, Foster E, Goldstein SA, Kuznetsova T, Lancellotti P, Muraru D, Picard MH, Rietzschel ER, Rudski L, Spencer KT, Tsang W, Voigt JU. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr. 2015 Jan;28(1):1-39.e14. doi: 10.1016/j.echo.2014.10.003.</citation>
      <PMID>25559473</PMID>
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      <citation>Rudski LG, Lai WW, Afilalo J, Hua L, Handschumacher MD, Chandrasekaran K, Solomon SD, Louie EK, Schiller NB. Guidelines for the echocardiographic assessment of the right heart in adults: a report from the American Society of Echocardiography endorsed by the European Association of Echocardiography, a registered branch of the European Society of Cardiology, and the Canadian Society of Echocardiography. J Am Soc Echocardiogr. 2010 Jul;23(7):685-713; quiz 786-8. doi: 10.1016/j.echo.2010.05.010. No abstract available.</citation>
      <PMID>20620859</PMID>
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      <citation>Harjola VP, Mebazaa A, Celutkiene J, Bettex D, Bueno H, Chioncel O, Crespo-Leiro MG, Falk V, Filippatos G, Gibbs S, Leite-Moreira A, Lassus J, Masip J, Mueller C, Mullens W, Naeije R, Nordegraaf AV, Parissis J, Riley JP, Ristic A, Rosano G, Rudiger A, Ruschitzka F, Seferovic P, Sztrymf B, Vieillard-Baron A, Yilmaz MB, Konstantinides S. Contemporary management of acute right ventricular failure: a statement from the Heart Failure Association and the Working Group on Pulmonary Circulation and Right Ventricular Function of the European Society of Cardiology. Eur J Heart Fail. 2016 Mar;18(3):226-41. doi: 10.1002/ejhf.478.</citation>
      <PMID>26995592</PMID>
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      <citation>Drazner MH, Rame JE, Stevenson LW, Dries DL. Prognostic importance of elevated jugular venous pressure and a third heart sound in patients with heart failure. N Engl J Med. 2001 Aug 23;345(8):574-81. doi: 10.1056/NEJMoa010641.</citation>
      <PMID>11529211</PMID>
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      <citation>Ghio S, Guazzi M, Scardovi AB, Klersy C, Clemenza F, Carluccio E, Temporelli PL, Rossi A, Faggiano P, Traversi E, Vriz O, Dini FL; all investigators. Different correlates but similar prognostic implications for right ventricular dysfunction in heart failure patients with reduced or preserved ejection fraction. Eur J Heart Fail. 2017 Jul;19(7):873-879. doi: 10.1002/ejhf.664. Epub 2016 Nov 17.</citation>
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    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Siena</investigator_affiliation>
      <investigator_full_name>Alberto Palazzuoli MD PhD</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Heart Failure</mesh_term>
      <mesh_term>Ventricular Dysfunction</mesh_term>
      <mesh_term>Ventricular Dysfunction, Right</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06002321
  org study id: RIVED - CHF
  nct id: NCT06002321
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this multi center observational prospective study is to analyze the concordance
        between the signs and symptoms of RHF and echocardiographic features of RVD in patient with
        heart failure. The main questions it aims to answer are:
  
          1. to assess the incidence of RVH and RVD in each HF subtypes.
  
          2. to evaluate prognostic impact ( in terms of cardiovascular mortality and HF
             hospitalization) of different RVD patterns during a mean followup period of 3 years
  
          3. To investigate the incidence of different RV maladaptation ( isolated RV dilatation,
             isolated Pulmonary hypertension, combined pattern) in each HF groups and the related
             outcome.
  
        Participants will follow by direct check up visit and/or virtual visits every 6 months for a
        mean follow-up period of 3 years.
  Right ventricular dysfunction (RVD) and pulmonary hypertension (PH) have been recognized as
        two important prognostic features in patients with left side heart failure (HF). Nevertheless
        literature does not distinguish between right heart failure (RHF) and RVD, and the two terms
        are indifferently employed to describe PH and impaired RV performance. This is a multicenter
        observational prospective study endorsed by the Italian Society of Cardiology that would
        analyse the concordance between the signs and symptoms of RHF and echocardiographic features
        of RVD. Therefore the right ventricle (RV) adaptation across different left ventricular
        ejection fraction (LVEF) values, is poorly investigated. According to the recent heart
        failure (HF) guidelines classified patients based on LVEF in HF with preserved ( HFpEF) mild
        reduced (HFmEF) and reduced LVEF ( HFrEF), the investigators would assess by seral clinical
        laboratory and detailed echocardiographic study all patients affected by chronic HF
        regardless LVEF threshold in stable condition and will follow by direct check up visit and/or
        virtual visits every 6 months for a mean follow-up period of 3 years. All clinical laboratory
        and echocardiographic data will be recorded in a web platform system accessible for all
        center included in the study The main aims of the study are; 1- to assess the incidence of
        RVH and RVD in each HF subtypes. 2- to evaluate prognostic impact ( in terms of
        cardiovascular mortality and HF hospitalization) of different RVD patterns during a mean
        followup period of 3 years 3- To investigate the incidence of different RV maladaptation (
        isolated RV dilatation, isolated Pulmonary hypertension, combined pattern) in each HF groups
        and the related outcome. The investigators expect to find different RVD degree and severity
        according to the type of left HF and its severity. Additionally, by a serial multiparametric
        analysis of RV, it would be possible to establish the stage and type of RVD and consequent
        concordance with signs of RHF.
  observational model: Case-Only
  time perspective: Prospective
  measure: Different patterns of RVD in chronic heart failure.
  time frame: 6 months.
  description: The different patterns of RVD will be evaluated with echocardiographic measurements. Right ventricular function will be assessed by the following echocardiographic parameters: tricuspid annular plane excursion (TAPSE) and right ventricular fractional area change (RVFAC).
  measure: Analyze the incidence and prevalence of RVD and RHF.
  time frame: 6 months.
  description: To analyze the incidence and prevalence of RVD and RHF according to left ventricular ejection fraction (HFrEF, HFmrEF, HFpEF).
  measure: Compare the clinical signs of right heart failure with the echocardiographic signs of RVD.
  time frame: 6 months.
  description: Compare clinical signs of right heart failure with echocardiographic parameters of right ventricular dysfunction in order to verify agreement and identify a precise relationship between RHF and RVD.
  measure: Define the incidence of RVD.
  time frame: 6 months.
  description: To define the incidence of RVD through a multiparametric echocardiographic analysis including all the echocardiographic parameters of right ventricular function in order to identify a precise score based on the simultaneous dysfunction of several parameters.
  measure: Investigate a correlation between the different parameters.
  time frame: 6 months.
  description: Investigate a correlation between echo parameters, clinical signs and laboratory data.
  arm group label: HFpEF
  description: The HFpEF group includes patients with signs and/or symptoms of heart failure and LVEF > 50% and objective evidence of structural and/or functional cardiac abnormalities consistent with the presence of LV diastolic dysfunction/raised LV filling pressures, including raised natriuretic peptides.
  arm group label: HFmrEF
  description: The HFmrEF group includes patients with signs and/or symptoms of heart failure and LVEF 41-49%.
  arm group label: HFrEF
  description: The HFrEF group includes patients with signs and/or symptoms of heart failure and LVEF < 40%.
  intervention type: Diagnostic Test
  intervention name: Echocardiography
  description: Patients will undergo echocardiographic examination. The ejection fraction will be calculated using Simpson's method. The E/e' ratio will be measured using the Doppler method. E/e' > 13 will be considered an expression of the increase in LVFP. TAPSE will be measured together with the peak tricuspid regurgitation velocity (TVR). Pulmonary arterial hypertension will be defined as TVR > 2.8 m/s. Estimation of right atrial pressure (eRAP) will be obtained based on the diameter and inspiratory collapsibility of the inferior vena cava.
  arm group label: HFmrEF
  arm group label: HFpEF
  arm group label: HFrEF
  intervention type: Diagnostic Test
  intervention name: Laboratory Test
  description: BNP, NT-proBNP and renal function.
  arm group label: HFmrEF
  arm group label: HFpEF
  arm group label: HFrEF
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 90 Years
  healthy volunteers: No
  last name: Alberto Palazzuoli, MD
  role: Study Director
  affiliation: Unità di Malattie Cardiovascolari, Dipartimento Cardio-Toraco-Vascolare AOUS, Siena
  last name: Alberto Palazzuoli, MD
  phone: +390577585363
  email: palazzuoli2@unisi.it
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  country: Italy
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  PMID: 25681425
  citation: Haddad F, Doyle R, Murphy DJ, Hunt SA. Right ventricular function in cardiovascular disease, part II: pathophysiology, clinical importance, and management of right ventricular failure. Circulation. 2008 Apr 1;117(13):1717-31. doi: 10.1161/CIRCULATIONAHA.107.653584. No abstract available.
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  citation: Meyer P, Filippatos GS, Ahmed MI, Iskandrian AE, Bittner V, Perry GJ, White M, Aban IB, Mujib M, Dell'Italia LJ, Ahmed A. Effects of right ventricular ejection fraction on outcomes in chronic systolic heart failure. Circulation. 2010 Jan 19;121(2):252-8. doi: 10.1161/CIRCULATIONAHA.109.887570. Epub 2010 Jan 4.
  PMID: 20048206
  citation: Voelkel NF, Gomez-Arroyo J, Abbate A, Bogaard HJ. Mechanisms of right heart failure-A work in progress and a plea for failure prevention. Pulm Circ. 2013 Jan;3(1):137-43. doi: 10.4103/2045-8932.109957. No abstract available.
  PMID: 23662190
  citation: Markel TA, Wairiuko GM, Lahm T, Crisostomo PR, Wang M, Herring CM, Meldrum DR. The right heart and its distinct mechanisms of development, function, and failure. J Surg Res. 2008 May 15;146(2):304-13. doi: 10.1016/j.jss.2007.04.003. Epub 2007 Nov 26.
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  citation: Ghio S, Acquaro M, Agostoni P, Ambrosio G, Carluccio E, Castiglione V, Colombo D, D'Alto M, Delle Grottaglie S, Dini FL, Emdin M, Fortunato M, Guaricci AI, Jacoangeli F, Marra AM, Paolillo S, Papa S, Scajola LV, Correale M, Palazzuoli A. Right heart failure in left heart disease: imaging, functional, and biochemical aspects of right ventricular dysfunction. Heart Fail Rev. 2023 Jul;28(4):1009-1022. doi: 10.1007/s10741-022-10276-0. Epub 2022 Nov 16.
  PMID: 36385328
  citation: de Groote P, Millaire A, Foucher-Hossein C, Nugue O, Marchandise X, Ducloux G, Lablanche JM. Right ventricular ejection fraction is an independent predictor of survival in patients with moderate heart failure. J Am Coll Cardiol. 1998 Oct;32(4):948-54. doi: 10.1016/s0735-1097(98)00337-4.
  PMID: 9768716
  citation: Gorter TM, van Veldhuisen DJ, Bauersachs J, Borlaug BA, Celutkiene J, Coats AJS, Crespo-Leiro MG, Guazzi M, Harjola VP, Heymans S, Hill L, Lainscak M, Lam CSP, Lund LH, Lyon AR, Mebazaa A, Mueller C, Paulus WJ, Pieske B, Piepoli MF, Ruschitzka F, Rutten FH, Seferovic PM, Solomon SD, Shah SJ, Triposkiadis F, Wachter R, Tschope C, de Boer RA. Right heart dysfunction and failure in heart failure with preserved ejection fraction: mechanisms and management. Position statement on behalf of the Heart Failure Association of the European Society of Cardiology. Eur J Heart Fail. 2018 Jan;20(1):16-37. doi: 10.1002/ejhf.1029. Epub 2017 Oct 16.
  PMID: 29044932
  citation: Nagueh SF, Bhatt R, Vivo RP, Krim SR, Sarvari SI, Russell K, Edvardsen T, Smiseth OA, Estep JD. Echocardiographic evaluation of hemodynamics in patients with decompensated systolic heart failure. Circ Cardiovasc Imaging. 2011 May;4(3):220-7. doi: 10.1161/CIRCIMAGING.111.963496. Epub 2011 Mar 11.
  PMID: 21398512
  citation: Sanz J, Sanchez-Quintana D, Bossone E, Bogaard HJ, Naeije R. Anatomy, Function, and Dysfunction of the Right Ventricle: JACC State-of-the-Art Review. J Am Coll Cardiol. 2019 Apr 2;73(12):1463-1482. doi: 10.1016/j.jacc.2018.12.076.
  PMID: 30922478
  citation: Drazner MH, Hamilton MA, Fonarow G, Creaser J, Flavell C, Stevenson LW. Relationship between right and left-sided filling pressures in 1000 patients with advanced heart failure. J Heart Lung Transplant. 1999 Nov;18(11):1126-32. doi: 10.1016/s1053-2498(99)00070-4.
  PMID: 10598737
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  PMID: 24875795
  citation: Bosch L, Lam CSP, Gong L, Chan SP, Sim D, Yeo D, Jaufeerally F, Leong KTG, Ong HY, Ng TP, Richards AM, Arslan F, Ling LH. Right ventricular dysfunction in left-sided heart failure with preserved versus reduced ejection fraction. Eur J Heart Fail. 2017 Dec;19(12):1664-1671. doi: 10.1002/ejhf.873. Epub 2017 Jun 8.
  PMID: 28597497
  citation: Gorter TM, Hoendermis ES, van Veldhuisen DJ, Voors AA, Lam CS, Geelhoed B, Willems TP, van Melle JP. Right ventricular dysfunction in heart failure with preserved ejection fraction: a systematic review and meta-analysis. Eur J Heart Fail. 2016 Dec;18(12):1472-1487. doi: 10.1002/ejhf.630. Epub 2016 Sep 20.
  PMID: 27650220
  citation: Guazzi M, Borlaug BA. Pulmonary hypertension due to left heart disease. Circulation. 2012 Aug 21;126(8):975-90. doi: 10.1161/CIRCULATIONAHA.111.085761. No abstract available.
  PMID: 22908015
  citation: Konstam MA, Kiernan MS, Bernstein D, Bozkurt B, Jacob M, Kapur NK, Kociol RD, Lewis EF, Mehra MR, Pagani FD, Raval AN, Ward C; American Heart Association Council on Clinical Cardiology; Council on Cardiovascular Disease in the Young; and Council on Cardiovascular Surgery and Anesthesia. Evaluation and Management of Right-Sided Heart Failure: A Scientific Statement From the American Heart Association. Circulation. 2018 May 15;137(20):e578-e622. doi: 10.1161/CIR.0000000000000560. Epub 2018 Apr 12.
  PMID: 29650544
  citation: Puwanant S, Priester TC, Mookadam F, Bruce CJ, Redfield MM, Chandrasekaran K. Right ventricular function in patients with preserved and reduced ejection fraction heart failure. Eur J Echocardiogr. 2009 Aug;10(6):733-7. doi: 10.1093/ejechocard/jep052. Epub 2009 May 13.
  PMID: 19443468
  citation: Barilli M, Tavera MC, Valente S, Palazzuoli A. Structural and Hemodynamic Changes of the Right Ventricle in PH-HFpEF. Int J Mol Sci. 2022 Apr 20;23(9):4554. doi: 10.3390/ijms23094554.
  PMID: 35562945
  citation: Dini FL, Pugliese NR, Ameri P, Attanasio U, Badagliacca R, Correale M, Mercurio V, Tocchetti CG, Agostoni P, Palazzuoli A; Heart Failure Study Group of the Italian Society of Cardiology. Right ventricular failure in left heart disease: from pathophysiology to clinical manifestations and prognosis. Heart Fail Rev. 2023 Jul;28(4):757-766. doi: 10.1007/s10741-022-10282-2. Epub 2022 Oct 26.
  PMID: 36284079
  citation: Schmeisser A, Rauwolf T, Groscheck T, Kropf S, Luani B, Tanev I, Hansen M, Meissler S, Steendijk P, Braun-Dullaeus RC. Pressure-volume loop validation of TAPSE/PASP for right ventricular arterial coupling in heart failure with pulmonary hypertension. Eur Heart J Cardiovasc Imaging. 2021 Jan 22;22(2):168-176. doi: 10.1093/ehjci/jeaa285.
  PMID: 33167032
  citation: Guazzi M, Bandera F, Pelissero G, Castelvecchio S, Menicanti L, Ghio S, Temporelli PL, Arena R. Tricuspid annular plane systolic excursion and pulmonary arterial systolic pressure relationship in heart failure: an index of right ventricular contractile function and prognosis. Am J Physiol Heart Circ Physiol. 2013 Nov 1;305(9):H1373-81. doi: 10.1152/ajpheart.00157.2013. Epub 2013 Aug 30.
  PMID: 23997100
  citation: Guazzi M, Dixon D, Labate V, Beussink-Nelson L, Bandera F, Cuttica MJ, Shah SJ. RV Contractile Function and its Coupling to Pulmonary Circulation in Heart Failure With Preserved Ejection Fraction: Stratification of Clinical Phenotypes and Outcomes. JACC Cardiovasc Imaging. 2017 Oct;10(10 Pt B):1211-1221. doi: 10.1016/j.jcmg.2016.12.024. Epub 2017 Apr 12.
  PMID: 28412423
  citation: Gheorghiade M, Follath F, Ponikowski P, Barsuk JH, Blair JE, Cleland JG, Dickstein K, Drazner MH, Fonarow GC, Jaarsma T, Jondeau G, Sendon JL, Mebazaa A, Metra M, Nieminen M, Pang PS, Seferovic P, Stevenson LW, van Veldhuisen DJ, Zannad F, Anker SD, Rhodes A, McMurray JJ, Filippatos G; European Society of Cardiology; European Society of Intensive Care Medicine. Assessing and grading congestion in acute heart failure: a scientific statement from the acute heart failure committee of the heart failure association of the European Society of Cardiology and endorsed by the European Society of Intensive Care Medicine. Eur J Heart Fail. 2010 May;12(5):423-33. doi: 10.1093/eurjhf/hfq045. Epub 2010 Mar 30.
  PMID: 20354029
  citation: McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available. Erratum In: Eur Heart J. 2021 Oct 14;:
  PMID: 34447992
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  responsible party type: Principal Investigator
  investigator affiliation: University of Siena
  investigator full name: Alberto Palazzuoli MD PhD
  investigator title: Professor
  mesh term: Heart Failure
  mesh term: Ventricular Dysfunction
  mesh term: Ventricular Dysfunction, Right
  sharing ipd: No