Cardiac Magnetic Resonance Assessment for Heart Failure With Preserved Ejection Fraction

Not Applicable

Completed

• Conditions: Heart Failure With Preserved Ejection Fraction

• Registration Number: NCT04063579
• Lead Sponsor: The University of Hong Kong

Brief Summary

This is a prospective study that aims to define the utility of cardiac magnetic resonance feature tracking (CMR-FT) as a non-invasive quantification tool to assess diastolic functionality in patients with Heart Failure with preserved ejection fraction.

Detailed Description

Despite the increasing prevalence and poor prognosis of HFpEF worldwide, it is facing diagnostic challenges due to its non-specific clinical manifestations. Currently, echocardiography serves as the main diagnostic tool, but alternatives are limited to less preferred invasive procedures in most clinical situations.

It is therefore proposed to investigate HFpEF using cardiovascular magnetic resonance imaging (CMR), as an alternative non-invasive diagnostic tool which carries lower risk than invasive procedures.

The study aims to: (1) access the utility of CMR-FT as a new indicator to diagnose diastolic dysfunction by differentiating HFpEF patients from non-HFpEF patient and normal volunteers. (2) Compare accuracy of CMR-FT to CMR tagging and phase contrast imaging.

Study Timeline

• Study Start: 2018-06-01
• Study First Submitted: 2019-08-16
• Study First Submitted QC: 2019-08-20
• Study First Posted: 2019-08-21
• Primary Completion: 2021-09-29
• Study Completion: 2021-12-31
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

• Patients presenting with symptoms and signs suggestive of HFpEF
• Patients undergoing coronary catheterisation for stable chest pain with no evidence of diastolic dysfunction, heart failure, infarct, left ventricular ejection fraction <50% or significant coronary artery disease (ie. >50% narrowing of one or more coronary arteries)
• Volunteers must be asymptomatic with no cardiac risk factors and no previous cardiac history

Exclusion Criteria

• Patients suspected to have HFpEF but echocardiography and/or invasive pressure measurements do not confirm diagnosis of HFpEF.
• Significant underlying ischaemia based on clinical history and non-invasive imaging or catheter coronary angiography if indicated.
• Contraindication to CMR study
• Estimated glomerular filtration rate <30 ml/min/1.73 m2
• More than moderate valvular disease
• Severe pulmonary disease (ie. FEV1 <- 50% predicted)
• Cardiomyopathy
• Constrictive pericarditis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Accuracy of feature tracking diastolic strain rate to diagnose diastolic dysfunction by differentiating HFpEF patients from the non-HFpEF patients and normal volunteers	2 years

Secondary Outcome Measures

Name	Time	Method
Complication rate of cardiac catheterisation	2 years
Unexpected findings by CMR (eg. Cardiac amyloidosis)	2 years

Trial Locations

Locations (1)

The University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong