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Cardiac Magnetic Resonance Assessment for Heart Failure With Preserved Ejection Fraction

The University of Hong Kong (HKU) logo

The University of Hong Kong (HKU)

Status

Completed

Conditions

Heart Failure With Preserved Ejection Fraction

Treatments

Diagnostic Test: Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP), cardiac catheterization
Diagnostic Test: Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP)

Study type

Interventional

Funder types

Other

Identifiers

NCT04063579
UW18-022

Details and patient eligibility

About

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.

Full 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.

Enrollment

172 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

172 participants in 3 patient groups

Patients with heart failure with preserved ejection fraction
Experimental group
Treatment:
Diagnostic Test: Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP), cardiac catheterization
Non-heart failure patients
Experimental group
Treatment:
Diagnostic Test: Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP), cardiac catheterization
Normal Volunteers
Experimental group
Treatment:
Diagnostic Test: Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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