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Trial record 1 of 1 for:    NCT03260621
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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

Tracking Information
First Submitted Date  ICMJE August 10, 2017
First Posted Date  ICMJE August 24, 2017
Last Update Posted Date November 16, 2020
Actual Study Start Date  ICMJE August 16, 2017
Actual Primary Completion Date September 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 23, 2017)
  • Cardiovascular magnetic resonance imaging [ Time Frame: approx. 1 years ]
    ventricular and atrial volumes
  • Cardiovascular magnetic resonance imaging [ Time Frame: approx. 1 years ]
    ventricular and atrial mechanics: strain
  • Cardiovascular magnetic resonance imaging [ Time Frame: approx. 1 years ]
    quantification of extracellular volume (ECV)/interstitial fibrosis
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: August 23, 2017)
  • Exercise spirometry [ Time Frame: approx. 1 years ]
    maximal oxygen uptake
  • Exercise spirometry [ Time Frame: approx. 1 years ]
    respiratory quotient
  • Exercise spirometry [ Time Frame: approx. 1 years ]
    power (watt/kg)
  • Right heart catheterization [ Time Frame: approx. 1 years ]
    reference for intracardiac pressures: pulmonary artery pressure and pulmonary capillary wedge pressure
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE CMR Exercise Stress Testing in HFpEF
Official Title  ICMJE Cardiovascular Magnetic Resonance Real-time Exercise Stress Testing in Heart Failure With Preserved Ejection Fraction
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Diastolic Heart Failure
Intervention  ICMJE Diagnostic Test: stress CMR
additional stress CMR to the established clinical diagnostics
Study Arms  ICMJE
  • echocardiographic increase in left atrial pressure
    Intervention: Diagnostic Test: stress CMR
  • echocardiographic no increase in left atrial pressure
    Intervention: Diagnostic Test: stress CMR
Publications * Backhaus SJ, Lange T, George EF, Hellenkamp K, Gertz RJ, Billing M, Wachter R, Steinmetz M, Kutty S, Raaz U, Lotz J, Friede T, Uecker M, Hasenfuß G, Seidler T, Schuster A. Exercise Stress Real-Time Cardiac Magnetic Resonance Imaging for Noninvasive Characterization of Heart Failure With Preserved Ejection Fraction: The HFpEF-Stress Trial. Circulation. 2021 Apr 13;143(15):1484-1498. doi: 10.1161/CIRCULATIONAHA.120.051542. Epub 2021 Jan 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 7, 2020)
75
Original Estimated Enrollment  ICMJE
 (submitted: August 23, 2017)
70
Actual Study Completion Date  ICMJE September 1, 2020
Actual Primary Completion Date September 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03260621
Other Study ID Numbers  ICMJE 35/8/15
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Responsible Party Andreas Schuster, University of Göttingen
Study Sponsor  ICMJE University of Göttingen
Collaborators  ICMJE Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Investigators  ICMJE
Principal Investigator: Andreas Schuster, MD, PhD University of Göttingen
PRS Account University of Göttingen
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP