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CMR Exercise Stress Testing in HFpEF (HFpEF-Stress)

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ClinicalTrials.gov Identifier: NCT03260621
Recruitment Status : Completed
First Posted : August 24, 2017
Last Update Posted : November 16, 2020
Sponsor:
Collaborator:
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Information provided by (Responsible Party):
Andreas Schuster, University of Göttingen

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diastolic Heart Failure Diagnostic Test: stress CMR Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Cardiovascular Magnetic Resonance Real-time Exercise Stress Testing in Heart Failure With Preserved Ejection Fraction
Actual Study Start Date : August 16, 2017
Actual Primary Completion Date : September 1, 2019
Actual Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
echocardiographic increase in left atrial pressure Diagnostic Test: stress CMR
additional stress CMR to the established clinical diagnostics

echocardiographic no increase in left atrial pressure Diagnostic Test: stress CMR
additional stress CMR to the established clinical diagnostics




Primary Outcome Measures :
  1. Cardiovascular magnetic resonance imaging [ Time Frame: approx. 1 years ]
    ventricular and atrial volumes

  2. Cardiovascular magnetic resonance imaging [ Time Frame: approx. 1 years ]
    ventricular and atrial mechanics: strain

  3. Cardiovascular magnetic resonance imaging [ Time Frame: approx. 1 years ]
    quantification of extracellular volume (ECV)/interstitial fibrosis


Other Outcome Measures:
  1. Exercise spirometry [ Time Frame: approx. 1 years ]
    maximal oxygen uptake

  2. Exercise spirometry [ Time Frame: approx. 1 years ]
    respiratory quotient

  3. Exercise spirometry [ Time Frame: approx. 1 years ]
    power (watt/kg)

  4. Right heart catheterization [ Time Frame: approx. 1 years ]
    reference for intracardiac pressures: pulmonary artery pressure and pulmonary capillary wedge pressure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients with dyspnoea under stress, echocardiographic criteria for diastolic dysfunction (E/E'>8) and clinical indication for right heart catheterisation

Exclusion Criteria:

  • arrhythmia (brady- or tachycardic)
  • bronchial asthma (allergic)
  • incompliant patient
  • pacemaker, ICD, non MRI-capable devices
  • inability to use the ergometer in the MRI
  • haemodynamic relevant valvular heart disease
  • pulmonary disease (vital capacity or forced expiratory flow <80% of healthy control)
  • angina pectoris
  • post cardiac infarction
  • anaemia (Hb <12 g/dl)
  • uncontrollable hypertension (>150 mmHg systolic or >100 mmHg diastolic)
  • age <18 years
  • pregnancy
  • claustrophobia
  • renal insufficiency
  • allergic to gadolinium based contrast agents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03260621


Locations
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Germany
University Hospital Goettingen
Göttingen, Germany, 37073
Sponsors and Collaborators
University of Göttingen
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Investigators
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Principal Investigator: Andreas Schuster, MD, PhD University of Göttingen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Andreas Schuster, PD Dr. med, University of Göttingen
ClinicalTrials.gov Identifier: NCT03260621    
Other Study ID Numbers: 35/8/15
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: November 16, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases