Cardiac Magnetic Resonance Assessment for Heart Failure With Preserved Ejection Fraction

NCT ID: NCT04063579

Last Updated: 2023-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

172 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2021-12-31

Brief Summary

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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

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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.

Conditions

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Heart Failure With Preserved Ejection Fraction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients with heart failure with preserved ejection fraction

Group Type EXPERIMENTAL

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

Intervention Type DIAGNOSTIC_TEST

Imaging, blood tests, LV pressure measurement

Non-heart failure patients

Group Type EXPERIMENTAL

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

Intervention Type DIAGNOSTIC_TEST

Imaging, blood tests, LV pressure measurement

Normal Volunteers

Group Type EXPERIMENTAL

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

Intervention Type DIAGNOSTIC_TEST

Imaging and Blood tests

Interventions

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

Imaging, blood tests, LV pressure measurement

Intervention Type DIAGNOSTIC_TEST

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

Imaging and Blood tests

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The University of Hong Kong

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

References

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Ng MY, Kwan CT, Yap PM, Fung SY, Tang HS, Tse WWV, Kwan CNF, Chow YHP, Yiu NC, Lee YP, Fong AHT, Hwang S, Fong ZFW, Ren QW, Wu MZ, Wan EYF, Lee KCK, Leung CY, Li A, Montero D, Vardhanabhuti V, Hai J, Siu CW, Tse HF, Pennell DJ, Mohiaddin R, Senior R, Yiu KH. Diagnostic accuracy of cardiovascular magnetic resonance strain analysis and atrial size to identify heart failure with preserved ejection fraction. Eur Heart J Open. 2023 Mar 7;3(2):oead021. doi: 10.1093/ehjopen/oead021. eCollection 2023 Mar.

Reference Type RESULT
PMID: 36992915 (View on PubMed)

Other Identifiers

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UW18-022

Identifier Type: -

Identifier Source: org_study_id

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