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Cardiac Magnetic Resonance Assessment for Heart Failure With Preserved Ejection Fraction

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ClinicalTrials.gov Identifier: NCT04063579
Recruitment Status : Recruiting
First Posted : August 21, 2019
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong

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.

Condition or disease Intervention/treatment Phase
Heart Failure With Preserved Ejection Fraction Diagnostic Test: Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP), cardiac catheterization Diagnostic Test: Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Cardiac Magnetic Resonance Assessment for Heart Failure With Preserved Ejection Fraction
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Patients with heart failure with preserved ejection fraction Diagnostic Test: Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP), cardiac catheterization
Imaging, blood tests, LV pressure measurement

Experimental: Non-heart failure patients Diagnostic Test: Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP), cardiac catheterization
Imaging, blood tests, LV pressure measurement

Experimental: Normal Volunteers Diagnostic Test: Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP)
Imaging and Blood tests




Primary Outcome Measures :
  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 Outcome Measures :
  1. Complication rate of cardiac catheterisation [ Time Frame: 2 years ]
  2. Unexpected findings by CMR (eg. Cardiac amyloidosis) [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04063579


Contacts
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Contact: Ming Yen Ng, BMBS 22554524 ext 4524 myng2@hku.hk

Locations
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Hong Kong
The University of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: Ming Yen Ng, BMBS    22554524    myng2@hku.hk   
Sponsors and Collaborators
The University of Hong Kong

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Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT04063579     History of Changes
Other Study ID Numbers: UW18-022
First Posted: August 21, 2019    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Natriuretic Peptide, Brain
Natriuretic Agents
Physiological Effects of Drugs