<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/NCT03260621</url>
  </required_header>
  <id_info>
    <org_study_id>35/8/15</org_study_id>
    <nct_id>NCT03260621</nct_id>
  </id_info>
  <brief_title>CMR Exercise Stress Testing in HFpEF</brief_title>
  <acronym>HFpEF-Stress</acronym>
  <official_title>Cardiovascular Magnetic Resonance Real-time Exercise Stress Testing in Heart Failure With Preserved Ejection Fraction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Göttingen</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>University of Göttingen</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>
      Patients of the University Hospital Göttingen with echocardiographic signs for diastolic&#xD;
      heart failure and indication for right heart catheterisation will undergo additional&#xD;
      diagnostic testing with CMR including exercise stress for detailed evaluation of diastolic&#xD;
      dysfunction and tissue characterisation correlating the results with well-established&#xD;
      clinical standards.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 16, 2017</start_date>
  <completion_date type="Actual">September 1, 2020</completion_date>
  <primary_completion_date type="Actual">September 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cardiovascular magnetic resonance imaging</measure>
    <time_frame>approx. 1 years</time_frame>
    <description>ventricular and atrial volumes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cardiovascular magnetic resonance imaging</measure>
    <time_frame>approx. 1 years</time_frame>
    <description>ventricular and atrial mechanics: strain</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cardiovascular magnetic resonance imaging</measure>
    <time_frame>approx. 1 years</time_frame>
    <description>quantification of extracellular volume (ECV)/interstitial fibrosis</description>
  </primary_outcome>
  <other_outcome>
    <measure>Exercise spirometry</measure>
    <time_frame>approx. 1 years</time_frame>
    <description>maximal oxygen uptake</description>
  </other_outcome>
  <other_outcome>
    <measure>Exercise spirometry</measure>
    <time_frame>approx. 1 years</time_frame>
    <description>respiratory quotient</description>
  </other_outcome>
  <other_outcome>
    <measure>Exercise spirometry</measure>
    <time_frame>approx. 1 years</time_frame>
    <description>power (watt/kg)</description>
  </other_outcome>
  <other_outcome>
    <measure>Right heart catheterization</measure>
    <time_frame>approx. 1 years</time_frame>
    <description>reference for intracardiac pressures: pulmonary artery pressure and pulmonary capillary wedge pressure</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Diastolic Heart Failure</condition>
  <arm_group>
    <arm_group_label>echocardiographic increase in left atrial pressure</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>echocardiographic no increase in left atrial pressure</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>stress CMR</intervention_name>
    <description>additional stress CMR to the established clinical diagnostics</description>
    <arm_group_label>echocardiographic increase in left atrial pressure</arm_group_label>
    <arm_group_label>echocardiographic no increase in left atrial pressure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult patients with dyspnoea under stress, echocardiographic criteria for diastolic&#xD;
             dysfunction (E/E'&gt;8) and clinical indication for right heart catheterisation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  arrhythmia (brady- or tachycardic)&#xD;
&#xD;
          -  bronchial asthma (allergic)&#xD;
&#xD;
          -  incompliant patient&#xD;
&#xD;
          -  pacemaker, ICD, non MRI-capable devices&#xD;
&#xD;
          -  inability to use the ergometer in the MRI&#xD;
&#xD;
          -  haemodynamic relevant valvular heart disease&#xD;
&#xD;
          -  pulmonary disease (vital capacity or forced expiratory flow &lt;80% of healthy control)&#xD;
&#xD;
          -  angina pectoris&#xD;
&#xD;
          -  post cardiac infarction&#xD;
&#xD;
          -  anaemia (Hb &lt;12 g/dl)&#xD;
&#xD;
          -  uncontrollable hypertension (&gt;150 mmHg systolic or &gt;100 mmHg diastolic)&#xD;
&#xD;
          -  age &lt;18 years&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  claustrophobia&#xD;
&#xD;
          -  renal insufficiency&#xD;
&#xD;
          -  allergic to gadolinium based contrast agents&#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>Andreas Schuster, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Göttingen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Goettingen</name>
      <address>
        <city>Göttingen</city>
        <zip>37073</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>November 13, 2020</last_update_submitted>
  <last_update_submitted_qc>November 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Göttingen</investigator_affiliation>
    <investigator_full_name>Andreas Schuster</investigator_full_name>
    <investigator_title>PD 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>
    <mesh_term>Heart Failure, Diastolic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The data acquired within the current study will be available via the german centre for cardiovascular research (DZHK) to researchers who successfully applied to undertake additional scientific studies based on DZHK data.</ipd_description>
  </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/NCT03260621
org study id: 35/8/15
nct id: NCT03260621
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Patients of the University Hospital Göttingen with echocardiographic signs for diastolic
      heart failure and indication for right heart catheterisation will undergo additional
      diagnostic testing with CMR including exercise stress for detailed evaluation of diastolic
      dysfunction and tissue characterisation correlating the results with well-established
      clinical standards.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Cardiovascular magnetic resonance imaging
time frame: approx. 1 years
description: ventricular and atrial volumes
measure: Cardiovascular magnetic resonance imaging
time frame: approx. 1 years
description: ventricular and atrial mechanics: strain
measure: Cardiovascular magnetic resonance imaging
time frame: approx. 1 years
description: quantification of extracellular volume (ECV)/interstitial fibrosis
measure: Exercise spirometry
time frame: approx. 1 years
description: maximal oxygen uptake
measure: Exercise spirometry
time frame: approx. 1 years
description: respiratory quotient
measure: Exercise spirometry
time frame: approx. 1 years
description: power (watt/kg)
measure: Right heart catheterization
time frame: approx. 1 years
description: reference for intracardiac pressures: pulmonary artery pressure and pulmonary capillary wedge pressure
arm group label: echocardiographic increase in left atrial pressure
arm group type: Other
arm group label: echocardiographic no increase in left atrial pressure
arm group type: Other
intervention type: Diagnostic Test
intervention name: stress CMR
description: additional stress CMR to the established clinical diagnostics
arm group label: echocardiographic increase in left atrial pressure
arm group label: echocardiographic no increase in left atrial pressure
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andreas Schuster, MD, PhD
role: Principal Investigator
affiliation: University of Göttingen
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University of Göttingen
investigator full name: Andreas Schuster
investigator title: PD Dr. med
mesh term: Heart Failure
mesh term: Heart Failure, Diastolic
sharing ipd: Yes
ipd description: The data acquired within the current study will be available via the german centre for cardiovascular research (DZHK) to researchers who successfully applied to undertake additional scientific studies based on DZHK data.