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Cardiac Magnetic Resonance Assessment for Heart Failure With Preserved Ejection Fraction

Cardiac Magnetic Resonance Assessment for Heart Failure With Preserved Ejection Fraction

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04063579
Enrollment
172
Registered
2019-08-21
Start date
2018-06-01
Completion date
2021-12-31
Last updated
2023-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure With Preserved Ejection Fraction

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.

Interventions

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

Imaging, blood tests, LV pressure measurement

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

Imaging and Blood tests

Sponsors

The University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Accuracy of feature tracking diastolic strain rate to diagnose diastolic dysfunction by differentiating HFpEF patients from the non-HFpEF patients and normal volunteers2 years

Secondary

MeasureTime frame
Complication rate of cardiac catheterisation2 years
Unexpected findings by CMR (eg. Cardiac amyloidosis)2 years

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026