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Completed

NCT Number: NCT04063579

Cardiac Magnetic Resonance Assessment for Heart Failure With Preserved Ejection Fraction

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Hong Kong

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Diagnostic Test

Imaging, blood tests, LV pressure measurement

Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP)

Diagnostic Test

Imaging and Blood tests

Primary outcomes

  1. Accuracy of feature tracking diastolic strain rate to diagnose diastolic dysfunction by differentiating HFpEF patients from the non-HFpEF patients and normal volunteers

    Time frame: 2 years

Secondary outcomes

  1. Complication rate of cardiac catheterisation

    Time frame: 2 years

  2. Unexpected findings by CMR (eg. Cardiac amyloidosis)

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Aug 21, 2019
Registry last updated
May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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