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CMR Exercise Stress Testing in HFpEF (HFpEF-Stress)

Primary Purpose

Diastolic Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
stress CMR
Sponsored by
University of Göttingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diastolic Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Goettingen

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

echocardiographic increase in left atrial pressure

echocardiographic no increase in left atrial pressure

Arm Description

Outcomes

Primary Outcome Measures

Cardiovascular magnetic resonance imaging
ventricular and atrial volumes
Cardiovascular magnetic resonance imaging
ventricular and atrial mechanics: strain
Cardiovascular magnetic resonance imaging
quantification of extracellular volume (ECV)/interstitial fibrosis

Secondary Outcome Measures

Full Information

First Posted
August 10, 2017
Last Updated
November 13, 2020
Sponsor
University of Göttingen
Collaborators
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
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1. Study Identification

Unique Protocol Identification Number
NCT03260621
Brief Title
CMR Exercise Stress Testing in HFpEF
Acronym
HFpEF-Stress
Official Title
Cardiovascular Magnetic Resonance Real-time Exercise Stress Testing in Heart Failure With Preserved Ejection Fraction
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
August 16, 2017 (Actual)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
September 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Göttingen
Collaborators
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diastolic Heart Failure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
echocardiographic increase in left atrial pressure
Arm Type
Other
Arm Title
echocardiographic no increase in left atrial pressure
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
stress CMR
Intervention Description
additional stress CMR to the established clinical diagnostics
Primary Outcome Measure Information:
Title
Cardiovascular magnetic resonance imaging
Description
ventricular and atrial volumes
Time Frame
approx. 1 years
Title
Cardiovascular magnetic resonance imaging
Description
ventricular and atrial mechanics: strain
Time Frame
approx. 1 years
Title
Cardiovascular magnetic resonance imaging
Description
quantification of extracellular volume (ECV)/interstitial fibrosis
Time Frame
approx. 1 years
Other Pre-specified Outcome Measures:
Title
Exercise spirometry
Description
maximal oxygen uptake
Time Frame
approx. 1 years
Title
Exercise spirometry
Description
respiratory quotient
Time Frame
approx. 1 years
Title
Exercise spirometry
Description
power (watt/kg)
Time Frame
approx. 1 years
Title
Right heart catheterization
Description
reference for intracardiac pressures: pulmonary artery pressure and pulmonary capillary wedge pressure
Time Frame
approx. 1 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Schuster, MD, PhD
Organizational Affiliation
University of Göttingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Goettingen
City
Göttingen
ZIP/Postal Code
37073
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
33472397
Citation
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.
Results Reference
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CMR Exercise Stress Testing in HFpEF

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