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/NCT05992558</url>
    </required_header>
    <id_info>
      <org_study_id>PI21/00541</org_study_id>
      <nct_id>NCT05992558</nct_id>
    </id_info>
    <brief_title>Longitudinal Multimarker Risk Models for Very Elderly Patients With Heart Failure and Preserved Ejection Fraction</brief_title>
    <official_title>Development of Longitudinal Multimarker Risk Models for Decision Support Across the Clinical Follow-up of Very Elderly Patients With Heart Failure and Preserved Ejection Fraction</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Instituto de Salud Carlos III</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>European Union</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <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 observational study is to develop longitudinal multimarker risk models for&#xD;
        decision support during the clinical follow-up of very elderly patients with heart failure&#xD;
        and preserved ejection fraction (HFpEF).&#xD;
  &#xD;
        The main questions it aims to answer are:&#xD;
  &#xD;
          -  Can advanced risk prediction models accurately estimate the prognosis of very elderly&#xD;
             patients with HFpEF over a 1-year follow-up after a hospitalization for acute heart&#xD;
             failure?&#xD;
  &#xD;
          -  Do novel biomarkers, in addition to routine clinical variables and elderly-specific&#xD;
             predictors, contribute to improved risk prediction for these patients?&#xD;
  &#xD;
        To this end, very elderly patients (aged 80 or older) who have HFpEF and were admitted for&#xD;
        acute heart failure will be included. Clinical and biological data will be collected during&#xD;
        their hospitalization and also during follow-up visits 30 and 90 days after discharge.&#xD;
  &#xD;
        There is no comparison group in this observational study.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background: Very elderly patients with heart failure and preserved ejection fraction (HFpEF)&#xD;
        are under-represented in risk prediction models, and the role of prognostic biomarkers in&#xD;
        this population is unclear due to the presence of cumulative comorbidity burden. Risk&#xD;
        prediction is a useful tool to support decision making across the clinical follow-up of very&#xD;
        elderly HFpEF patients.&#xD;
  &#xD;
        Aim: To develop longitudinal prognostic models based on readily available clinical and&#xD;
        biological variables, novel biomarkers and elderly-specific predictors to estimate prognosis&#xD;
        over 1-year follow-up after a HF hospitalization in very elderly patients with HFpEF.&#xD;
  &#xD;
        Design: Observational, single-centre, prospective cohort study of very elderly patients (≥80&#xD;
        years old) with HFpEF consecutively admitted for acute HF.&#xD;
  &#xD;
        Main outcome: Composite of 1-year all-cause mortality and/or HF-hospitalization. Sample size:&#xD;
        184 patients.&#xD;
  &#xD;
        Follow-up time: 1 year. Predictors: Routine clinical variables (sociodemographic, medical&#xD;
        history, physical examination, vital signs, laboratory tests, imaging, concomitant&#xD;
        medication, quality of life and elderly-specific factors) and novel biomarkers will be&#xD;
        longitudinally collected during index hospitalization, 30-day and 90-day post-discharge&#xD;
        visits.&#xD;
  &#xD;
        Statistical analysis: Kaplan-meier survival analysis. Logistic and Cox proportional-hazards&#xD;
        regression models, time-to-event models for repeated events, linear-mixed effects, joint&#xD;
        models, LASSO and machine learning techniques will be used for model development.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 21, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>12 Months</target_duration>
    <primary_outcome>
      <measure>Composite of 1-year all-cause mortality and/or HF-hospitalization</measure>
      <time_frame>12 months</time_frame>
      <description>Combined outcome of all-cause mortality and/or readmission for acute heart failure during a 12-month follow-up period after index hospitalization</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>1-year HF-hospitalization</measure>
      <time_frame>12 months</time_frame>
      <description>Readmission for acute heart failure during a 12-month follow-up period after index hospitalization</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>3-month HF-hospitalization</measure>
      <time_frame>3 months</time_frame>
      <description>Readmission for acute heart failure during a 3-month follow-up period after index hospitalization</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>1-month HF-hospitalization</measure>
      <time_frame>1 month</time_frame>
      <description>Readmission for acute heart failure during a 1-month follow-up period after index hospitalization</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>1-year all-cause hospitalization</measure>
      <time_frame>12 months</time_frame>
      <description>All-cause readmission during a 12-month follow-up period after index hospitalization</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>3-month all-cause hospitalization</measure>
      <time_frame>3 months</time_frame>
      <description>All-cause readmission during a 3-month follow-up period after index hospitalization</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>1-month all-cause hospitalization</measure>
      <time_frame>1 month</time_frame>
      <description>All-cause readmission during a 1-month follow-up period after index hospitalization</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>1-year all-cause mortality</measure>
      <time_frame>12 months</time_frame>
      <description>All-cause mortality during a 12-month follow-up period after index hospitalization</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>1-year cardiovascular mortality</measure>
      <time_frame>12 months</time_frame>
      <description>Cardiovascular mortality during a 12-month follow-up period after index hospitalization</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>1-year urgent HF visits</measure>
      <time_frame>12 months</time_frame>
      <description>Urgent or unscheduled visit with new or worsening symptoms of acute heart failure requiring initiation of intravenous diuretic or vasoactive agent or mechanical or surgical intervention, with no hospital admission, during a 12-month follow-up period after index hospitalization</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>3-month urgent HF visits</measure>
      <time_frame>3 months</time_frame>
      <description>Urgent or unscheduled visit with new or worsening symptoms of acute heart failure requiring initiation of intravenous diuretic or vasoactive agent or mechanical or surgical intervention, with no hospital admission, during a 3-month follow-up period after index hospitalization</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>1-month urgent HF visits</measure>
      <time_frame>1 month</time_frame>
      <description>Urgent or unscheduled visit with new or worsening symptoms of acute heart failure requiring initiation of intravenous diuretic or vasoactive agent or mechanical or surgical intervention, with no hospital admission, during a 1-month follow-up period after index hospitalization</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>1-year worsening in NYHA class</measure>
      <time_frame>12 months</time_frame>
      <description>Worsening of New York Heart Association (NYHA) Functional Classification (Class I to IV) at 12 months from the index hospitalization.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">184</enrollment>
    <condition>Heart Failure With Preserved Ejection Fraction</condition>
    <arm_group>
      <arm_group_label>Very elderly HFpEF</arm_group_label>
      <description>Prospective cohort of very elderly patients (≥80 years old) with heart failure with preserved ejection fraction (HFpEF) consecutively admitted for acute HF</description>
    </arm_group>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Serum, EDTA plasma, lithium heparin plasma, and buffy coat.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Very elderly patients (≥80 years old) with HFpEF consecutively admitted for acute HF at&#xD;
          Hospital Universitario Ramón y Cajal and followed up at Unit of Heart Failure (UICA) of the&#xD;
          Internal Medicine Dept.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. age ≥80 years;&#xD;
  &#xD;
            2. diagnosis of HFpEF, requiring the 4 following conditions: b1) typical symptoms and/or&#xD;
               signs of HF; b2) left ventricular ejection fraction (LVEF) ≥50%; b3) elevated levels&#xD;
               of natriuretic peptides (NTproBNP ≥300 pg/mL or BNP ≥100 pg/mL in sinus rhythm;&#xD;
               NT-proBNP ≥900 pg/mL or BNP ≥300 pg/mL in atrial fibrillation); and b4) at least one&#xD;
               additional criterion: b4.1) relevant structural heart disease (left ventricular&#xD;
               hypertrophy and/or left atrial enlargement), or 4.2) diastolic dysfunction;&#xD;
  &#xD;
            3. hospitalization with a primary diagnosis of acute HF; and&#xD;
  &#xD;
            4. giving informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. any clinical condition, such as HF secondary to congenital heart disease and severe&#xD;
               valve disease, severe renal (requiring dialysis) and liver disease, active malignant&#xD;
               diseases, autoimmune diseases, other diseases resulting in &lt;1-year life expectancy or&#xD;
               any other condition that, according to investigators' criteria, could significantly&#xD;
               interfere with the study objectives;&#xD;
  &#xD;
            2. any clinical or social condition that prevents clinical follow-up.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>80 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Luis Manzano Espinosa, MD PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hospital Universitario Ramón y Cajal</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Luis Manzano Espinosa, MD PhD</last_name>
      <phone>0034913369204</phone>
      <email>luis.manzano@uah.es</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Martin Fabregate Fuente, MEng</last_name>
      <phone>0034913369082</phone>
      <email>martin.fabregate@salud.madrid.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Hospital Universitario Ramón y Cajal</name>
        <address>
          <city>Madrid</city>
          <zip>28034</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Luis Manzano Espinosa, MD PhD</last_name>
        <phone>0034913369204</phone>
        <email>luis.manzano@uah.es</email>
      </contact>
      <contact_backup>
        <last_name>Martin Fabregate Fuente, MEng</last_name>
        <phone>0034636936650</phone>
        <email>martin.fabregate@salud.madrid.org</email>
      </contact_backup>
      <investigator>
        <last_name>Jose María Fernández Rodríguez, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Pau Llácer Iborra, MD PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <reference>
      <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>
    <reference>
      <citation>Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2022 May 3;79(17):1757-1780. doi: 10.1016/j.jacc.2021.12.011. Epub 2022 Apr 1.</citation>
      <PMID>35379504</PMID>
    </reference>
    <reference>
      <citation>Taylor CJ, Moore J, O'Flynn N. Diagnosis and management of chronic heart failure: NICE guideline update 2018. Br J Gen Pract. 2019 May;69(682):265-266. doi: 10.3399/bjgp19X702665. No abstract available.</citation>
      <PMID>31023695</PMID>
    </reference>
    <reference>
      <citation>Sicras-Mainar A, Sicras-Navarro A, Palacios B, Varela L, Delgado JF. Epidemiology and treatment of heart failure in Spain: the HF-PATHWAYS study. Rev Esp Cardiol (Engl Ed). 2022 Jan;75(1):31-38. doi: 10.1016/j.rec.2020.09.033. Epub 2020 Dec 27. English, Spanish.</citation>
      <PMID>33380382</PMID>
    </reference>
    <reference>
      <citation>Kuster N, Huet F, Dupuy AM, Akodad M, Battistella P, Agullo A, Leclercq F, Kalmanovich E, Meilhac A, Aguilhon S, Cristol JP, Roubille F. Multimarker approach including CRP, sST2 and GDF-15 for prognostic stratification in stable heart failure. ESC Heart Fail. 2020 Oct;7(5):2230-2239. doi: 10.1002/ehf2.12680. Epub 2020 Jul 10.</citation>
      <PMID>32649062</PMID>
    </reference>
    <reference>
      <citation>Nunez J, Bayes-Genis A, Revuelta-Lopez E, Ter Maaten JM, Minana G, Barallat J, Cserkoova A, Bodi V, Fernandez-Cisnal A, Nunez E, Sanchis J, Lang C, Ng LL, Metra M, Voors AA. Clinical Role of CA125 in Worsening Heart Failure: A BIOSTAT-CHF Study Subanalysis. JACC Heart Fail. 2020 May;8(5):386-397. doi: 10.1016/j.jchf.2019.12.005. Epub 2020 Mar 11.</citation>
      <PMID>32171764</PMID>
    </reference>
    <reference>
      <citation>Pacho C, Domingo M, Nunez R, Lupon J, Nunez J, Barallat J, Moliner P, de Antonio M, Santesmases J, Cediel G, Roura S, Pastor MC, Tor J, Bayes-Genis A. Predictive biomarkers for death and rehospitalization in comorbid frail elderly heart failure patients. BMC Geriatr. 2018 May 9;18(1):109. doi: 10.1186/s12877-018-0807-2.</citation>
      <PMID>29743019</PMID>
    </reference>
    <reference>
      <citation>Levy WC, Mozaffarian D, Linker DT, Sutradhar SC, Anker SD, Cropp AB, Anand I, Maggioni A, Burton P, Sullivan MD, Pitt B, Poole-Wilson PA, Mann DL, Packer M. The Seattle Heart Failure Model: prediction of survival in heart failure. Circulation. 2006 Mar 21;113(11):1424-33. doi: 10.1161/CIRCULATIONAHA.105.584102. Epub 2006 Mar 13.</citation>
      <PMID>16534009</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Heart Failure</keyword>
    <keyword>Preserved Ejection Fraction</keyword>
    <keyword>Elderly</keyword>
    <keyword>Prognostic model</keyword>
    <keyword>Risk</keyword>
    <keyword>Hospitalization</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Heart Failure</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>After the end of the project, the generated dataset and the metadata file will be deposited in an open data repository, complying with open science criteria - FAIR.&#xD;
  Moreover, study documentation, including study protocol, statistical analysis and informed consent form will be shared openly.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>From 1 year after the end of the project and for at least 5 years.</ipd_time_frame>
      <ipd_access_criteria>IPD will be available to stakeholders, authorities, ethics committees and other parties legitimately interested in verifying their proper treatment and management.&#xD;
  IPD may be used to ensure the scientific quality of the project results. That is to say, to carry out reproducibility of the results, if necessary at the request of scientific publication entities, among others, with prior authorization from the Research Ethics Committee, they may be reused for new research projects, provided that the consent collected allows it and/or in accordance with the applicable laws on data protection.</ipd_access_criteria>
    </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/NCT05992558
  org study id: PI21/00541
  nct id: NCT05992558
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to develop longitudinal multimarker risk models for
        decision support during the clinical follow-up of very elderly patients with heart failure
        and preserved ejection fraction (HFpEF).
  
        The main questions it aims to answer are:
  
          -  Can advanced risk prediction models accurately estimate the prognosis of very elderly
             patients with HFpEF over a 1-year follow-up after a hospitalization for acute heart
             failure?
  
          -  Do novel biomarkers, in addition to routine clinical variables and elderly-specific
             predictors, contribute to improved risk prediction for these patients?
  
        To this end, very elderly patients (aged 80 or older) who have HFpEF and were admitted for
        acute heart failure will be included. Clinical and biological data will be collected during
        their hospitalization and also during follow-up visits 30 and 90 days after discharge.
  
        There is no comparison group in this observational study.
  Background: Very elderly patients with heart failure and preserved ejection fraction (HFpEF)
        are under-represented in risk prediction models, and the role of prognostic biomarkers in
        this population is unclear due to the presence of cumulative comorbidity burden. Risk
        prediction is a useful tool to support decision making across the clinical follow-up of very
        elderly HFpEF patients.
  
        Aim: To develop longitudinal prognostic models based on readily available clinical and
        biological variables, novel biomarkers and elderly-specific predictors to estimate prognosis
        over 1-year follow-up after a HF hospitalization in very elderly patients with HFpEF.
  
        Design: Observational, single-centre, prospective cohort study of very elderly patients (≥80
        years old) with HFpEF consecutively admitted for acute HF.
  
        Main outcome: Composite of 1-year all-cause mortality and/or HF-hospitalization. Sample size:
        184 patients.
  
        Follow-up time: 1 year. Predictors: Routine clinical variables (sociodemographic, medical
        history, physical examination, vital signs, laboratory tests, imaging, concomitant
        medication, quality of life and elderly-specific factors) and novel biomarkers will be
        longitudinally collected during index hospitalization, 30-day and 90-day post-discharge
        visits.
  
        Statistical analysis: Kaplan-meier survival analysis. Logistic and Cox proportional-hazards
        regression models, time-to-event models for repeated events, linear-mixed effects, joint
        models, LASSO and machine learning techniques will be used for model development.
  observational model: Cohort
  time perspective: Prospective
  measure: Composite of 1-year all-cause mortality and/or HF-hospitalization
  time frame: 12 months
  description: Combined outcome of all-cause mortality and/or readmission for acute heart failure during a 12-month follow-up period after index hospitalization
  measure: 1-year HF-hospitalization
  time frame: 12 months
  description: Readmission for acute heart failure during a 12-month follow-up period after index hospitalization
  measure: 3-month HF-hospitalization
  time frame: 3 months
  description: Readmission for acute heart failure during a 3-month follow-up period after index hospitalization
  measure: 1-month HF-hospitalization
  time frame: 1 month
  description: Readmission for acute heart failure during a 1-month follow-up period after index hospitalization
  measure: 1-year all-cause hospitalization
  time frame: 12 months
  description: All-cause readmission during a 12-month follow-up period after index hospitalization
  measure: 3-month all-cause hospitalization
  time frame: 3 months
  description: All-cause readmission during a 3-month follow-up period after index hospitalization
  measure: 1-month all-cause hospitalization
  time frame: 1 month
  description: All-cause readmission during a 1-month follow-up period after index hospitalization
  measure: 1-year all-cause mortality
  time frame: 12 months
  description: All-cause mortality during a 12-month follow-up period after index hospitalization
  measure: 1-year cardiovascular mortality
  time frame: 12 months
  description: Cardiovascular mortality during a 12-month follow-up period after index hospitalization
  measure: 1-year urgent HF visits
  time frame: 12 months
  description: Urgent or unscheduled visit with new or worsening symptoms of acute heart failure requiring initiation of intravenous diuretic or vasoactive agent or mechanical or surgical intervention, with no hospital admission, during a 12-month follow-up period after index hospitalization
  measure: 3-month urgent HF visits
  time frame: 3 months
  description: Urgent or unscheduled visit with new or worsening symptoms of acute heart failure requiring initiation of intravenous diuretic or vasoactive agent or mechanical or surgical intervention, with no hospital admission, during a 3-month follow-up period after index hospitalization
  measure: 1-month urgent HF visits
  time frame: 1 month
  description: Urgent or unscheduled visit with new or worsening symptoms of acute heart failure requiring initiation of intravenous diuretic or vasoactive agent or mechanical or surgical intervention, with no hospital admission, during a 1-month follow-up period after index hospitalization
  measure: 1-year worsening in NYHA class
  time frame: 12 months
  description: Worsening of New York Heart Association (NYHA) Functional Classification (Class I to IV) at 12 months from the index hospitalization.
  arm group label: Very elderly HFpEF
  description: Prospective cohort of very elderly patients (≥80 years old) with heart failure with preserved ejection fraction (HFpEF) consecutively admitted for acute HF
  Serum, EDTA plasma, lithium heparin plasma, and buffy coat.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 80 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Luis Manzano Espinosa, MD PhD
  role: Principal Investigator
  affiliation: Hospital Universitario Ramón y Cajal
  last name: Luis Manzano Espinosa, MD PhD
  phone: 0034913369204
  email: luis.manzano@uah.es
  last name: Martin Fabregate Fuente, MEng
  phone: 0034913369082
  email: martin.fabregate@salud.madrid.org
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  country: Spain
  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: Sponsor
  mesh term: Heart Failure
  sharing ipd: Yes
  ipd description: After the end of the project, the generated dataset and the metadata file will be deposited in an open data repository, complying with open science criteria - FAIR.
  Moreover, study documentation, including study protocol, statistical analysis and informed consent form will be shared openly.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: From 1 year after the end of the project and for at least 5 years.
  ipd access criteria: IPD will be available to stakeholders, authorities, ethics committees and other parties legitimately interested in verifying their proper treatment and management.
  IPD may be used to ensure the scientific quality of the project results. That is to say, to carry out reproducibility of the results, if necessary at the request of scientific publication entities, among others, with prior authorization from the Research Ethics Committee, they may be reused for new research projects, provided that the consent collected allows it and/or in accordance with the applicable laws on data protection.