NCT04063579

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 21, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

3.3 years

First QC Date

August 16, 2019

Last Update Submit

May 8, 2023

Conditions

Heart Failure With Preserved Ejection Fraction

Outcome Measures

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

    2 years

Secondary Outcomes (2)

  • Complication rate of cardiac catheterisation

    2 years

  • Unexpected findings by CMR (eg. Cardiac amyloidosis)

    2 years

Study Arms (3)

Patients with heart failure with preserved ejection fraction

EXPERIMENTAL
Diagnostic Test: Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP), cardiac catheterization

Non-heart failure patients

EXPERIMENTAL
Diagnostic Test: Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP), cardiac catheterization

Normal Volunteers

EXPERIMENTAL
Diagnostic Test: Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP)

Interventions

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

Imaging, blood tests, LV pressure measurement

Non-heart failure patientsPatients with heart failure with preserved ejection fraction
Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP)DIAGNOSTIC_TEST

Imaging and Blood tests

Normal Volunteers

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (1)

  • 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.

    PMID: 36992915RESULT

MeSH Terms

Interventions

EchocardiographyCardiac Catheterization

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, CardiovascularCatheterizationTherapeuticsInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2019

First Posted

August 21, 2019

Study Start

June 1, 2018

Primary Completion

September 29, 2021

Study Completion

December 31, 2021

Last Updated

May 10, 2023

Record last verified: 2023-05

Locations

HK(1)