CMR Exercise Stress Testing in HFpEF

Diastolic Heart Failure Clinical Trial

— HFpEF-Stress  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03260621
• Other study ID #: 35/8/15
• Status: Completed
• Phase: N/A
• Start date: August 16, 2017
• Est. completion date: September 1, 2020

Study information

• Verified date: November 2020
• Source: University of Göttingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: September 1, 2020
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diastolic Heart Failure
• Heart Failure
• Heart Failure, Diastolic

Intervention

Diagnostic Test:
• stress CMR
additional stress CMR to the established clinical diagnostics

Locations

Country	Name	City	State
Germany	University Hospital Goettingen	Göttingen

Sponsors (2)

Lead Sponsor	Collaborator
University of Göttingen	Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exercise spirometry	maximal oxygen uptake	approx. 1 years
Other	Exercise spirometry	respiratory quotient	approx. 1 years
Other	Exercise spirometry	power (watt/kg)	approx. 1 years
Other	Right heart catheterization	reference for intracardiac pressures: pulmonary artery pressure and pulmonary capillary wedge pressure	approx. 1 years
Primary	Cardiovascular magnetic resonance imaging	ventricular and atrial volumes	approx. 1 years
Primary	Cardiovascular magnetic resonance imaging	ventricular and atrial mechanics: strain	approx. 1 years
Primary	Cardiovascular magnetic resonance imaging	quantification of extracellular volume (ECV)/interstitial fibrosis	approx. 1 years