<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/NCT03251183</url>
  </required_header>
  <id_info>
    <org_study_id>Protocol_ Version 1 20170225</org_study_id>
    <nct_id>NCT03251183</nct_id>
  </id_info>
  <brief_title>Validation of CMR Against Invasive Haemodynamics in Patients With HFpEF</brief_title>
  <acronym>DECIPHER-HFpEF</acronym>
  <official_title>Validation of Cardiovascular Magnetic Resonance Against Invasive Haemodynamics in Patients With Heart Failure With Preserved Ejection Fraction (DECIPHER HFpEF)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Goethe University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Goethe University</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>
      Heart failure (HF) currently affects app. 2% of the western population and app. 10% of people&#xD;
      &gt;75 years. In about 50% of patients with symptomatic HF ejection fraction (EF) is preserved&#xD;
      (HF-PEF). Once patients develop symptoms, the prognosis is poor with 25% mortality at 1 year&#xD;
      and 50% mortality at 5 years. HFpEF is one of the major unresolved areas in clinical&#xD;
      cardiology. The diagnosis of HFpEF remains a diagnosis of exclusion and currently no&#xD;
      non-invasive measure provides a clear diagnosis.&#xD;
&#xD;
      Cardiovascular magnetic resonance (CMR) provides non invasive and radiation free evaluation&#xD;
      of heart structure and function. New CMR parameters offer the possibility to describe the&#xD;
      underlying pathological and physiological changes associated with HFpEF.&#xD;
&#xD;
      The investigators propose to undertake the first systematic comparison between a CMR protocol&#xD;
      and invasive haemodynamics as the best possible gold standard, as well as define the&#xD;
      histopathological drivers in myocardial biopsies. The investigators will also examine the&#xD;
      relations with tissue and serological biomarkers implicated in HFpEF and the role with&#xD;
      standard and novel parameters by echocardiography. If successful, this study will provide&#xD;
      tools for a reliable and accurate non-invasive characterization of patients with HFpEF,&#xD;
      supporting the diagnosis and grading the severity of disease. This study will provide a&#xD;
      reference basis for future diagnostic algorithms in HFpEF, both, for CMR and&#xD;
      echocardiography, but also for their relative value in comparison to blood markers or&#xD;
      invasive testing. In addition to a new pathway to acess the effects of current and novel&#xD;
      therapeutic interventions, the investigators see the greatest potential in identifying a&#xD;
      disease stage where the myocardial injury may be reversible.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 14, 2018</start_date>
  <completion_date type="Actual">December 31, 2022</completion_date>
  <primary_completion_date type="Actual">December 31, 2022</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Significant influence of MR Imaging Parameters on a multivariate model to describe the invasive pressure volume relations (EDPVR).</measure>
    <time_frame>up to 4 weeks. No follow up is planned.</time_frame>
    <description>Using a multivariable regression analysis and a respective F test.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Association between CMR T1-mapping and biopsy results.</measure>
    <time_frame>up to 4 weeks. No follow up is planned.</time_frame>
    <description>Using suitable regression and correlation Analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between CMR flow echocardiographic flow</measure>
    <time_frame>up to 4 weeks. No follow up is planned.</time_frame>
    <description>Using suitable regression and correlation Analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between a model for diastolic function based on CMR with a model of diastolic function based on echocardiography</measure>
    <time_frame>up to 4 weeks. No follow up is planned.</time_frame>
    <description>Using suitable regression and correlation Analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between CMR function and echocardiographic function</measure>
    <time_frame>up to 4 weeks. No follow up is planned.</time_frame>
    <description>Using suitable regression and correlation Analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Discriminatory capacity of a multivariate model of invasive and a multivariate model of non-invasive variables.</measure>
    <time_frame>up to 4 weeks. No follow up is planned.</time_frame>
    <description>Using the patient and control groups with comparative ROC analysis and DeLong tests.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reproducibility at one site.</measure>
    <time_frame>up to 4 weeks. No follow up is planned.</time_frame>
    <description>Using respective intra-class correlations in the groups with multiple measurements.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variability between the different sites.</measure>
    <time_frame>up to 4 weeks. No follow up is planned.</time_frame>
    <description>Using respective intra-class correlations in the groups with multiple measurements.</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">185</enrollment>
  <condition>Heart Failure With Normal Ejection Fraction</condition>
  <arm_group>
    <arm_group_label>Main group</arm_group_label>
    <description>Blood sampling Comprehensive Cardiovascular magnetic resonance (CMR) Transthoracic echocardiography (TTE) (EchoErgo) Invasive pressure-volume (PV) Loops Left ventricular (LV) biopsy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Reproducibility group</arm_group_label>
    <description>Stress-perfusion Cardiovascular magnetic resonance (CMR)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Age/gender matched control group</arm_group_label>
    <description>Blood sampling Stress-perfusion Cardiovascular magnetic resonance (CMR) TTE (EchoErgo)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <description>Blood sampling Stress-perfusion Cardiovascular magnetic resonance (CMR) TTE (EchoErgo)</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Comprehensive Cardiovascular magnetic resonance (CMR)</intervention_name>
    <description>Cardiovascular magnetic resonance (CMR) provides non-invasive, radiation-free and in-depth evaluation of myocardial structure and function. In addition to established tools for assessment of cardiac volume, mass, function and regional myocardial scar with late Gadolinium enhancement (LGE), several novel quantitative CMR parameters will be assessed including T1-mapping or fully quantitative perfusion Imaging.</description>
    <arm_group_label>Age/gender matched control group</arm_group_label>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <arm_group_label>Main group</arm_group_label>
    <arm_group_label>Reproducibility group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Blood sampling</intervention_name>
    <description>Blood samples will eventually be analysed for markers related to heart failure (BNP/NT)-pro-BNP, myocardial inflammation and fibrosis (cytokine profiling, Galectin-3, Procollagen Type I and III, hsCRP). Whole blood will be frozen for DNA isolation and genome analysis. Peripheral blood mononuclear cells will be isolated by Ficoll in a subset of patients and will be used for RNA isolation allowing RNA-seq or reverse transcription (RT) - polymerase chain reaction (PCR) analysis.</description>
    <arm_group_label>Age/gender matched control group</arm_group_label>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <arm_group_label>Main group</arm_group_label>
    <arm_group_label>Reproducibility group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>TTE (EchoErgo)</intervention_name>
    <description>Measurements will include cavity dimensions, flow velocities, myocardial motion velocity and strain as well as for change of parameters during ergometric stress.</description>
    <arm_group_label>Age/gender matched control group</arm_group_label>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <arm_group_label>Main group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Invasive pressure-volume (PV) Loops</intervention_name>
    <description>Multiple parameters (including EDPVR, ESPVR, dp/dt min, Tau, Ea) will be derived from the various PV loop assessments and additional relevant parameters will be calculated. Right ventricular and pulmonary pressures including pulmonary vascular resistance will be measured with Swan-Ganz catheters using right venous femoral approach.</description>
    <arm_group_label>Main group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Left ventricular (LV) biopsy</intervention_name>
    <description>A set of myocardial biopsies for each patient will be stained with Masson Trichrome for qualitative and quantitative assessment of the collagen volume fraction; fat droplets will be identified by red oil staining, Congo Red for amyloid immunohistology will be used to determine total leukocytes (CD45), T-cells (CD3) and monocytes/macrophages (CD68).&#xD;
A second set of biopsies will be frozen immediately and stored at -80°. Western blot analysis will be performed to determine alterations at the myofilament level including titin isoform composition and phosphorylation status.</description>
    <arm_group_label>Main group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with diagnostic criteria for HFpEF, age/gender matched controls and healty&#xD;
        volunteers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Main/reproducibility group:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          1. Ability to provide informed consent&#xD;
&#xD;
          2. Typical HF symptoms (NYHA stage II-III) within the last 6 months&#xD;
&#xD;
          3. EF &gt; 45 % with absence of structural heart disease on echocardiography (except left&#xD;
             ventricular hypertrophy or left atrial enlargement)&#xD;
&#xD;
          4. Echocardiographic evidence of increased left ventricular filling pressures&#xD;
&#xD;
               1. E/E'sep &gt;15 OR E/E'lat &gt;12 OR Av E/E' &gt;13 OR&#xD;
&#xD;
               2. E/E' &gt;9 AND left atrial (LA) volume &gt;34 ml/m2 OR systolic pulmonary artery&#xD;
                  pressure (PAsys): &gt;35 mmHg;&#xD;
&#xD;
          5. Indication for invasive hemodynamic work-up&#xD;
&#xD;
          6. Unclear aetiology of heart failure&#xD;
&#xD;
          7. Adults: age &gt;18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients unable or unwilling to provide informed consent&#xD;
&#xD;
          2. High likelihood of non-diagnostic PV loops of MR imaging (e.g. atrial fibrillation or&#xD;
             high rate of premature ventricular contraction (PVC) (&gt; 10 ventricular Extrasystole&#xD;
             (VES)/minute), &gt; 150 kg body weight, inability to lie flat or still)&#xD;
&#xD;
          3. Contraindication for invasive work-up (allergy to contrast agent, severe renal&#xD;
             insufficiency with estimated glomerular filtration rate (eGRF) &lt;30 ml/min)&#xD;
&#xD;
          4. Contraindications for a contrast enhanced CMR study (allergy to contrast agent,&#xD;
             incompatible devices or implants (e.g. non-MR conditional pacemaker), severe&#xD;
             claustrophobia)&#xD;
&#xD;
          5. Previous medical history of EF &lt;45%&#xD;
&#xD;
          6. Imaging findings confirming a specific diagnosis of myocardial impairment (e.g.&#xD;
             amyloid, ischaemic heart disease, valvular disease)&#xD;
&#xD;
        Age-gender matched controls:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          1. Ability to provide informed consent&#xD;
&#xD;
          2. No current or history of symptoms, signs or therapy for heart disease&#xD;
&#xD;
          3. EF &gt; 45 % with absence of structural heart disease on echocardiography (except left&#xD;
             ventricular hypertrophy or left atrial enlargement)&#xD;
&#xD;
          4. Adults: age &gt;18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients unable or unwilling to provide informed consent&#xD;
&#xD;
          2. High likelihood of non-diagnostic MR imaging (e.g. atrial fibrillation or high rate of&#xD;
             PVC (&gt; 10 VES/minute), &gt; 150 kg body weight, inability to lie flat or still)&#xD;
&#xD;
          3. Contraindications for a contrast enhanced CMR study (allergy to contrast agent,&#xD;
             incompatible devices or implants (e.g. non-MR conditional pacemaker), severe&#xD;
             claustrophobia, severe renal insufficiency with eGRF &lt;30 ml/min))&#xD;
&#xD;
          4. Previous medical history of EF &lt;45%&#xD;
&#xD;
          5. Imaging findings confirming a specific diagnosis of myocardial impairment (e.g.&#xD;
             amyloid, ischaemic heart disease, valvular disease)&#xD;
&#xD;
        Healthy volunteers:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          1. Ability to provide informed consent&#xD;
&#xD;
          2. No current or history of symptoms, signs or therapy for heart disease&#xD;
&#xD;
          3. EF ≥ 50 % with absence of structural heart disease on echocardiography&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Contraindications for an MR study&#xD;
&#xD;
          2. High likelihood of non-diagnostic MR imaging (e.g. atrial fibrillation or high rate of&#xD;
             PVC (&gt; 10 VES/minute), &gt; 150 kg body weight, inability to lie flat or still)&#xD;
&#xD;
          3. Subjects unable or unwilling to provide informed consent&#xD;
&#xD;
          4. EF &lt;50% in patient history&#xD;
&#xD;
          5. Imaging findings confirming a specific diagnosis of myocardial impairment (e.g.&#xD;
             amyloid, ischaemic heart disease, valvular disease)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eike C Nagel, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Goethe University Frankfurt</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Frankfurt</name>
      <address>
        <city>Frankfurt</city>
        <state>Hesse</state>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kerckhoff Klinik</name>
      <address>
        <city>Bad Nauheim</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charite Centrum Herz-, Kreislauf- und Gefäßmedizin</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Göttingen</name>
      <address>
        <city>Göttingen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>Heidelberg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herzzentrum Leipzig</name>
      <address>
        <city>Leipzig</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniersity Hospital Mainz</name>
      <address>
        <city>Mainz</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>May 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>March 8, 2023</last_update_submitted>
  <last_update_submitted_qc>March 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Goethe University</investigator_affiliation>
    <investigator_full_name>Prof. Eike Nagel</investigator_full_name>
    <investigator_title>Univ. Prof. Dr. med.</investigator_title>
  </responsible_party>
  <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>All data will be shared with other researchers within the German Centre for Cardiovascular Research (DZHK) via the Use and Access Rules</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>1 year after finalization of primary analysis</ipd_time_frame>
    <ipd_access_criteria>Via Use and Access Policy of DZHK</ipd_access_criteria>
    <ipd_url>https://www.dzhk.de</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03251183
org study id: Protocol_ Version 1 20170225
nct id: NCT03251183
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Heart failure (HF) currently affects app. 2% of the western population and app. 10% of people
      >75 years. In about 50% of patients with symptomatic HF ejection fraction (EF) is preserved
      (HF-PEF). Once patients develop symptoms, the prognosis is poor with 25% mortality at 1 year
      and 50% mortality at 5 years. HFpEF is one of the major unresolved areas in clinical
      cardiology. The diagnosis of HFpEF remains a diagnosis of exclusion and currently no
      non-invasive measure provides a clear diagnosis.

      Cardiovascular magnetic resonance (CMR) provides non invasive and radiation free evaluation
      of heart structure and function. New CMR parameters offer the possibility to describe the
      underlying pathological and physiological changes associated with HFpEF.

      The investigators propose to undertake the first systematic comparison between a CMR protocol
      and invasive haemodynamics as the best possible gold standard, as well as define the
      histopathological drivers in myocardial biopsies. The investigators will also examine the
      relations with tissue and serological biomarkers implicated in HFpEF and the role with
      standard and novel parameters by echocardiography. If successful, this study will provide
      tools for a reliable and accurate non-invasive characterization of patients with HFpEF,
      supporting the diagnosis and grading the severity of disease. This study will provide a
      reference basis for future diagnostic algorithms in HFpEF, both, for CMR and
      echocardiography, but also for their relative value in comparison to blood markers or
      invasive testing. In addition to a new pathway to acess the effects of current and novel
      therapeutic interventions, the investigators see the greatest potential in identifying a
      disease stage where the myocardial injury may be reversible.
observational model: Cohort
time perspective: Prospective
measure: Significant influence of MR Imaging Parameters on a multivariate model to describe the invasive pressure volume relations (EDPVR).
time frame: up to 4 weeks. No follow up is planned.
description: Using a multivariable regression analysis and a respective F test.
measure: Association between CMR T1-mapping and biopsy results.
time frame: up to 4 weeks. No follow up is planned.
description: Using suitable regression and correlation Analysis.
measure: Association between CMR flow echocardiographic flow
time frame: up to 4 weeks. No follow up is planned.
description: Using suitable regression and correlation Analysis.
measure: Association between a model for diastolic function based on CMR with a model of diastolic function based on echocardiography
time frame: up to 4 weeks. No follow up is planned.
description: Using suitable regression and correlation Analysis.
measure: Association between CMR function and echocardiographic function
time frame: up to 4 weeks. No follow up is planned.
description: Using suitable regression and correlation Analysis.
measure: Discriminatory capacity of a multivariate model of invasive and a multivariate model of non-invasive variables.
time frame: up to 4 weeks. No follow up is planned.
description: Using the patient and control groups with comparative ROC analysis and DeLong tests.
measure: Reproducibility at one site.
time frame: up to 4 weeks. No follow up is planned.
description: Using respective intra-class correlations in the groups with multiple measurements.
measure: Variability between the different sites.
time frame: up to 4 weeks. No follow up is planned.
description: Using respective intra-class correlations in the groups with multiple measurements.
arm group label: Main group
description: Blood sampling Comprehensive Cardiovascular magnetic resonance (CMR) Transthoracic echocardiography (TTE) (EchoErgo) Invasive pressure-volume (PV) Loops Left ventricular (LV) biopsy
arm group label: Reproducibility group
description: Stress-perfusion Cardiovascular magnetic resonance (CMR)
arm group label: Age/gender matched control group
description: Blood sampling Stress-perfusion Cardiovascular magnetic resonance (CMR) TTE (EchoErgo)
arm group label: Healthy volunteers
description: Blood sampling Stress-perfusion Cardiovascular magnetic resonance (CMR) TTE (EchoErgo)
intervention type: Diagnostic Test
intervention name: Comprehensive Cardiovascular magnetic resonance (CMR)
description: Cardiovascular magnetic resonance (CMR) provides non-invasive, radiation-free and in-depth evaluation of myocardial structure and function. In addition to established tools for assessment of cardiac volume, mass, function and regional myocardial scar with late Gadolinium enhancement (LGE), several novel quantitative CMR parameters will be assessed including T1-mapping or fully quantitative perfusion Imaging.
arm group label: Age/gender matched control group
arm group label: Healthy volunteers
arm group label: Main group
arm group label: Reproducibility group
intervention type: Diagnostic Test
intervention name: Blood sampling
description: Blood samples will eventually be analysed for markers related to heart failure (BNP/NT)-pro-BNP, myocardial inflammation and fibrosis (cytokine profiling, Galectin-3, Procollagen Type I and III, hsCRP). Whole blood will be frozen for DNA isolation and genome analysis. Peripheral blood mononuclear cells will be isolated by Ficoll in a subset of patients and will be used for RNA isolation allowing RNA-seq or reverse transcription (RT) - polymerase chain reaction (PCR) analysis.
arm group label: Age/gender matched control group
arm group label: Healthy volunteers
arm group label: Main group
arm group label: Reproducibility group
intervention type: Diagnostic Test
intervention name: TTE (EchoErgo)
description: Measurements will include cavity dimensions, flow velocities, myocardial motion velocity and strain as well as for change of parameters during ergometric stress.
arm group label: Age/gender matched control group
arm group label: Healthy volunteers
arm group label: Main group
intervention type: Diagnostic Test
intervention name: Invasive pressure-volume (PV) Loops
description: Multiple parameters (including EDPVR, ESPVR, dp/dt min, Tau, Ea) will be derived from the various PV loop assessments and additional relevant parameters will be calculated. Right ventricular and pulmonary pressures including pulmonary vascular resistance will be measured with Swan-Ganz catheters using right venous femoral approach.
arm group label: Main group
intervention type: Diagnostic Test
intervention name: Left ventricular (LV) biopsy
description: A set of myocardial biopsies for each patient will be stained with Masson Trichrome for qualitative and quantitative assessment of the collagen volume fraction; fat droplets will be identified by red oil staining, Congo Red for amyloid immunohistology will be used to determine total leukocytes (CD45), T-cells (CD3) and monocytes/macrophages (CD68).
A second set of biopsies will be frozen immediately and stored at -80°. Western blot analysis will be performed to determine alterations at the myofilament level including titin isoform composition and phosphorylation status.
arm group label: Main group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Eike C Nagel, MD, PhD
role: Principal Investigator
affiliation: Goethe University Frankfurt
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Goethe University
investigator full name: Prof. Eike Nagel
investigator title: Univ. Prof. Dr. med.
mesh term: Heart Failure
sharing ipd: Yes
ipd description: All data will be shared with other researchers within the German Centre for Cardiovascular Research (DZHK) via the Use and Access Rules
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: 1 year after finalization of primary analysis
ipd access criteria: Via Use and Access Policy of DZHK
ipd url: https://www.dzhk.de