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Clinical Trials/NCT04063579
NCT04063579
Completed
Not Applicable

Cardiac Magnetic Resonance Assessment for Heart Failure With Preserved Ejection Fraction

The University of Hong Kong1 site in 1 country172 target enrollmentJune 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure With Preserved Ejection Fraction
Sponsor
The University of Hong Kong
Enrollment
172
Locations
1
Primary Endpoint
Accuracy of feature tracking diastolic strain rate to diagnose diastolic dysfunction by differentiating HFpEF patients from the non-HFpEF patients and normal volunteers
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2018
End Date
December 31, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

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

Study Sites (1)

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