CMR Exercise Stress Testing in HFpEF (HFpEF-Stress)

Cardiovascular Magnetic Resonance Real-time Exercise Stress Testing in Heart Failure With Preserved Ejection Fraction

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.

Study Overview

• Status: Completed
• Conditions: Diastolic Heart Failure
• Intervention / Treatment: Diagnostic test: stress CMR

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Göttingen, Germany, 37073
    • University Hospital Goettingen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: echocardiographic increase in left atrial pressure	Diagnostic test: stress CMR; additional stress CMR to the established clinical diagnostics
Other: echocardiographic no increase in left atrial pressure	Diagnostic test: stress CMR; additional stress CMR to the established clinical diagnostics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular magnetic resonance imaging	ventricular and atrial volumes	approx. 1 years
Cardiovascular magnetic resonance imaging	ventricular and atrial mechanics: strain	approx. 1 years
Cardiovascular magnetic resonance imaging	quantification of extracellular volume (ECV)/interstitial fibrosis	approx. 1 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise spirometry	maximal oxygen uptake	approx. 1 years
Exercise spirometry	respiratory quotient	approx. 1 years
Exercise spirometry	power (watt/kg)	approx. 1 years
Right heart catheterization	reference for intracardiac pressures: pulmonary artery pressure and pulmonary capillary wedge pressure	approx. 1 years

Collaborators and Investigators

• Sponsor: University of Göttingen
• Collaborators: Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
• Investigators: Principal Investigator: Andreas Schuster, MD, PhD, University of Göttingen

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2017
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: August 10, 2017
• First Submitted That Met QC Criteria: August 23, 2017
• First Posted (Actual): August 24, 2017

Study Record Updates

• Last Update Posted (Actual): November 16, 2020
• Last Update Submitted That Met QC Criteria: November 13, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Heart Failure, Diastolic
• Other Study ID Numbers: 35/8/15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No