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/NCT06023134</url>
    </required_header>
    <id_info>
      <org_study_id>PH-RHF</org_study_id>
      <nct_id>NCT06023134</nct_id>
    </id_info>
    <brief_title>Clinical Characteristics and Outcomes of Patients With Pulmonary Hypertension Associated Right Heart Failure</brief_title>
    <official_title>Clinical Characteristics and Outcomes of Patients With Pulmonary Hypertension Associated Right Heart Failure</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Jingyi Ren</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>China-Japan Friendship Hospital</source>
    <oversight_info>
      <has_dmc>Yes</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 study aims to describe the clinical characteristics and clarify the predictors of the&#xD;
        short- and long-term outcomes of RHF patients, further assist the diagnosis, risk&#xD;
        stratification and treatment of RHF.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Right heart failure(RHF) is a clinical syndrome with symptoms, signs, and evidence of right&#xD;
        ventricular systolic and/or diastolic dysfunction. For many years, it was largely neglected&#xD;
        in the consideration of left-sided heart failure, while it is now evident that RHF is not&#xD;
        only common but its presence also strongly contributes to increased morbidity and mortality.&#xD;
        The in-hospital mortality of RHF is 7%, and the 30-day readmission rate is 20%. Therefore,&#xD;
        diagnosis, potential treatment strategies, and prognosis improvement have become an unmet&#xD;
        need in the field of cardiovascular disease.&#xD;
  &#xD;
        In clinical practice, accurate diagnosis of RHF is the key to timely initiation of treatment&#xD;
        and improvement of prognosis. Although current guidelines recommend clinical symptoms and&#xD;
        signs combined with echocardiography, cardiac magnetic resonance, and other imaging means to&#xD;
        evaluate right heart dysfunction for comprehensive diagnosis of right heart failure, the key&#xD;
        diagnostic indicators included are inconsistent, the weight ratio of each indicator is&#xD;
        different, the diagnostic threshold is not uniform, and the lack of comprehensive diagnostic&#xD;
        model system brings great challenges to clinical practice.&#xD;
  &#xD;
        This study aims to integrate multiple clinical biomarkers, imaging, and hemodynamic data to&#xD;
        describe the clinical characteristics, establish noninvasive easy-to-use diagnosis models for&#xD;
        right heart failure, and explore the risk factors for short- and long-term poor prognosis in&#xD;
        patients with RHF.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">January 1, 2015</start_date>
    <completion_date type="Anticipated">December 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Time to first event of adjudicated CV death mortality or adjudicated HHF</measure>
      <time_frame>24 weeks</time_frame>
      <description>The composite primary endpoint for this trial is the time to first event of adjudicated CV death or adjudicated hospitalization for heart failure （HHF） in patients with right heart failure.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Occurrence of adjudicated HHF (first and recurrent)</measure>
      <time_frame>24 weeks</time_frame>
      <description>any hospital admission due to HHF in 24 weeks</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to adjudicated CV death</measure>
      <time_frame>24 weeks</time_frame>
      <description>any CV death in 24 weeks</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to all-cause mortality</measure>
      <time_frame>24 weeks</time_frame>
      <description>any all-cause mortality in 24 weeks</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to first all-cause hospitalisation</measure>
      <time_frame>24 weeks</time_frame>
      <description>any hospital admission in 24 weeks</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Composite of time to first event of all-cause mortality and all cause hospitalisation</measure>
      <time_frame>24 weeks</time_frame>
      <description>The composite primary endpoint for this trial is the time to first event of all-cause mortality and all cause hospitalisation in patients with pulmonary hypertension</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in NYHA class from baseline at week 24</measure>
      <time_frame>24 weeks</time_frame>
      <description>Patients are assessed for NYHA class at each admission</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) from baseline over time</measure>
      <time_frame>24 weeks</time_frame>
      <description>Change from baseline to week 24 in N-terminal pro-brain natriuretic peptide (NT-proBNP).Baseline value was defined as the mean of all available measurements at the time of the first right heart catheterization</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in liver functions from baseline over time</measure>
      <time_frame>24 weeks</time_frame>
      <description>Change of transaminase or bilirubin from baseline to week 24 .Baseline value was defined as the mean of all available measurements at the time of the first right heart catheterization</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in renal function from baseline over time</measure>
      <time_frame>24 weeks</time_frame>
      <description>Change of estimated Glomerular Filtration Rate from baseline to week 24. The baseline value was defined as the mean of all available measurements at the time of the first right heart catheterization</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in echocardiographic data from baseline over time</measure>
      <time_frame>24 weeks</time_frame>
      <description>Change from baseline to week 24 in echocardiographic data. Baseline value was defined as the mean of all available measurements at the time of the first right heart catheterization</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in ECG data from baseline over time</measure>
      <time_frame>24 weeks</time_frame>
      <description>Change from baseline to week 24 in ECG data.Baseline value was defined as the mean of all available measurements at the time of the first right heart catheterization</description>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">800</enrollment>
    <condition>Right Heart Failure</condition>
    <condition>Pulmonary Hypertension</condition>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <description>Participants met the indication for right heart catheterization but did not meet the diagnostic criteria for pulmonary hypertension and right heart failure.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Pulmonary Hypertension group</arm_group_label>
      <description>Participants were classified according to the 2022 ESC/ERS guidelines for the diagnosis and treatment of pulmonary hypertension, meaning that a mean pulmonary artery pressure (mPAP) ≥20 mmHg was defined as PH.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Right heart failure group</arm_group_label>
      <description>Right heart failure was considered present when RV fractional area change (FAC) was &lt;35% or tricuspid annular systolic velocity (RV S') was &lt;9.5 cm/s or tricuspid annular plane systolic excursion (TAPSE) &lt;17mm.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Echocardiography</intervention_name>
      <description>Echocardiography will be used for specific right ventricular measurements or findings: TAPSE, TAPSE:PASP ratio, tissue Doppler velocity at lateral tricuspid annulus, fractional area change, right ventricular strain, right ventricular hypertrophy, right atrial size, volumes, ejection fraction, tricuspid and pulmonary regurgitation, inferior vena cava diameter and collapsibility, shift of interventricular septum, further assisting the diagnosis of RHF.</description>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_label>Pulmonary Hypertension group</arm_group_label>
      <arm_group_label>Right heart failure group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Right heart catheterization</intervention_name>
      <description>Right heart catheterization is the &quot;gold standard&quot; for the diagnosis of PH. It also allows for direct measurement of intracardiac and pulmonary pressures, as well as cardiac output, and is commonly used to estimate right ventricular preload and afterload.</description>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_label>Pulmonary Hypertension group</arm_group_label>
      <arm_group_label>Right heart failure group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The participants who met the indications for right heart catheterization were monitored by&#xD;
          hemodynamics and evaluated cardiac function by echocardiography. Those who met the&#xD;
          diagnostic criteria for pulmonary hypertension were included in the pulmonary hypertension&#xD;
          group, those who also met the diagnostic criteria for right heart failure were included in&#xD;
          the right heart failure group, and the rest of the patients were included in the control&#xD;
          group.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Aged ≥18 years at the time of consent&#xD;
  &#xD;
            2. Acceptation of right heart catheterization examination&#xD;
  &#xD;
            3. Able to perform the entire protocol&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Life expectancy of less than 1 year based on the investigator's clinical judgment&#xD;
  &#xD;
            2. Pregnant or nursing&#xD;
  &#xD;
            3. Malignancy&#xD;
  &#xD;
            4. Planned to undergo heart transplantation or device implantation&#xD;
  &#xD;
            5. Acute coronary syndrome, uncontrolled severe arrhythmia and shock.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jingyi Ren</last_name>
      <role>Principal Investigator</role>
      <affiliation>China-Japan Friendship Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>China-Japan Friendship Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>China-Japan Friendship Hospital</investigator_affiliation>
      <investigator_full_name>Jingyi Ren</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Right heart failure</keyword>
    <keyword>Prognosis</keyword>
    <keyword>Right ventricular function</keyword>
    <keyword>Pulmonary hypertension</keyword>
    <keyword>Biomarkers</keyword>
    <keyword>diagnosis</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypertension, Pulmonary</mesh_term>
      <mesh_term>Hypertension</mesh_term>
      <mesh_term>Heart Failure</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/NCT06023134
  org study id: PH-RHF
  nct id: NCT06023134
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The study aims to describe the clinical characteristics and clarify the predictors of the
        short- and long-term outcomes of RHF patients, further assist the diagnosis, risk
        stratification and treatment of RHF.
  Right heart failure(RHF) is a clinical syndrome with symptoms, signs, and evidence of right
        ventricular systolic and/or diastolic dysfunction. For many years, it was largely neglected
        in the consideration of left-sided heart failure, while it is now evident that RHF is not
        only common but its presence also strongly contributes to increased morbidity and mortality.
        The in-hospital mortality of RHF is 7%, and the 30-day readmission rate is 20%. Therefore,
        diagnosis, potential treatment strategies, and prognosis improvement have become an unmet
        need in the field of cardiovascular disease.
  
        In clinical practice, accurate diagnosis of RHF is the key to timely initiation of treatment
        and improvement of prognosis. Although current guidelines recommend clinical symptoms and
        signs combined with echocardiography, cardiac magnetic resonance, and other imaging means to
        evaluate right heart dysfunction for comprehensive diagnosis of right heart failure, the key
        diagnostic indicators included are inconsistent, the weight ratio of each indicator is
        different, the diagnostic threshold is not uniform, and the lack of comprehensive diagnostic
        model system brings great challenges to clinical practice.
  
        This study aims to integrate multiple clinical biomarkers, imaging, and hemodynamic data to
        describe the clinical characteristics, establish noninvasive easy-to-use diagnosis models for
        right heart failure, and explore the risk factors for short- and long-term poor prognosis in
        patients with RHF.
  observational model: Cohort
  time perspective: Retrospective
  measure: Time to first event of adjudicated CV death mortality or adjudicated HHF
  time frame: 24 weeks
  description: The composite primary endpoint for this trial is the time to first event of adjudicated CV death or adjudicated hospitalization for heart failure （HHF） in patients with right heart failure.
  measure: Occurrence of adjudicated HHF (first and recurrent)
  time frame: 24 weeks
  description: any hospital admission due to HHF in 24 weeks
  measure: Time to adjudicated CV death
  time frame: 24 weeks
  description: any CV death in 24 weeks
  measure: Time to all-cause mortality
  time frame: 24 weeks
  description: any all-cause mortality in 24 weeks
  measure: Time to first all-cause hospitalisation
  time frame: 24 weeks
  description: any hospital admission in 24 weeks
  measure: Composite of time to first event of all-cause mortality and all cause hospitalisation
  time frame: 24 weeks
  description: The composite primary endpoint for this trial is the time to first event of all-cause mortality and all cause hospitalisation in patients with pulmonary hypertension
  measure: Change in NYHA class from baseline at week 24
  time frame: 24 weeks
  description: Patients are assessed for NYHA class at each admission
  measure: Changes in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) from baseline over time
  time frame: 24 weeks
  description: Change from baseline to week 24 in N-terminal pro-brain natriuretic peptide (NT-proBNP).Baseline value was defined as the mean of all available measurements at the time of the first right heart catheterization
  measure: Change in liver functions from baseline over time
  time frame: 24 weeks
  description: Change of transaminase or bilirubin from baseline to week 24 .Baseline value was defined as the mean of all available measurements at the time of the first right heart catheterization
  measure: Change in renal function from baseline over time
  time frame: 24 weeks
  description: Change of estimated Glomerular Filtration Rate from baseline to week 24. The baseline value was defined as the mean of all available measurements at the time of the first right heart catheterization
  measure: Change in echocardiographic data from baseline over time
  time frame: 24 weeks
  description: Change from baseline to week 24 in echocardiographic data. Baseline value was defined as the mean of all available measurements at the time of the first right heart catheterization
  measure: Change in ECG data from baseline over time
  time frame: 24 weeks
  description: Change from baseline to week 24 in ECG data.Baseline value was defined as the mean of all available measurements at the time of the first right heart catheterization
  arm group label: Control group
  description: Participants met the indication for right heart catheterization but did not meet the diagnostic criteria for pulmonary hypertension and right heart failure.
  arm group label: Pulmonary Hypertension group
  description: Participants were classified according to the 2022 ESC/ERS guidelines for the diagnosis and treatment of pulmonary hypertension, meaning that a mean pulmonary artery pressure (mPAP) ≥20 mmHg was defined as PH.
  arm group label: Right heart failure group
  description: Right heart failure was considered present when RV fractional area change (FAC) was <35% or tricuspid annular systolic velocity (RV S') was <9.5 cm/s or tricuspid annular plane systolic excursion (TAPSE) <17mm.
  intervention type: Diagnostic Test
  intervention name: Echocardiography
  description: Echocardiography will be used for specific right ventricular measurements or findings: TAPSE, TAPSE:PASP ratio, tissue Doppler velocity at lateral tricuspid annulus, fractional area change, right ventricular strain, right ventricular hypertrophy, right atrial size, volumes, ejection fraction, tricuspid and pulmonary regurgitation, inferior vena cava diameter and collapsibility, shift of interventricular septum, further assisting the diagnosis of RHF.
  arm group label: Control group
  arm group label: Pulmonary Hypertension group
  arm group label: Right heart failure group
  intervention type: Diagnostic Test
  intervention name: Right heart catheterization
  description: Right heart catheterization is the "gold standard" for the diagnosis of PH. It also allows for direct measurement of intracardiac and pulmonary pressures, as well as cardiac output, and is commonly used to estimate right ventricular preload and afterload.
  arm group label: Control group
  arm group label: Pulmonary Hypertension group
  arm group label: Right heart failure group
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jingyi Ren
  role: Principal Investigator
  affiliation: China-Japan Friendship Hospital
  facility: 
  country: China
  responsible party type: Sponsor-Investigator
  investigator affiliation: China-Japan Friendship Hospital
  investigator full name: Jingyi Ren
  investigator title: Professor
  mesh term: Hypertension, Pulmonary
  mesh term: Hypertension
  mesh term: Heart Failure
  sharing ipd: No