Heart Failure With Preserved Ejection Fraction: Evaluation and Recognition by CMR

ConditionsHeart Failure With Preserved Ejection Fraction Heart Diseases

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorUniversity of East Anglia

About this trial

Heart failure with preserved ejection fraction (HFpEF) is a common and growing condition with a poor prognosis but the pathophysiology and management are still being investigated. The PREFER-CMR project aims to evaluate and validate the application of novel 4D cardiac magnetic resonance flow dynamic methods to measure left ventricular pressures and validate these measurements with direct pressure measurement by coronary angiography. This is a prospective observational study of patients with HFpEF undergoing clinical evaluation with coronary angiography who will also undergo contemporaneous cardiac MRI. The primary outcome will be the level of agreement between the two methods using angiography as the reference method.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults: age≥18 years.

Typical HF symptoms (NYHA stage>I) within the last six months.

Raised NTproBNP (>400 pg/ml)

EF>50 % with the absence of structural heart disease on TTE (except left ventricular hypertrophy or left atrial enlargement).

Disqualifiers

Patients unable/unwilling to provide informed consent.

Bodyweight>120 kg or inability to lie flat/still.

Contraindication for invasive workup (allergy to contrast, severe renal insufficiency with estimated glomerular filtration rate (eGRF)<30 ml/min).

Contraindications for a contrast-enhanced CMR study (allergy to contrast, incompatible devices or implants, severe claustrophobia).

Trial population

* Suspected heart failure patients * Suspected coronary artery disease patients

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Multi Parametric Cardiac Magnetic Resonance
Diagnostic test
Research based Cardiac MRI evaluation to determine cardiovascular haemodynamics

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: HFpEF group1 intervention

Group B: Control group1 intervention

Trial outcomes

Primary outcomes

Left ventricular pressure measured by invasive angiography (reference method) and modelled by cardiovascular magnetic resonance imaging

Agreement of invasively measured left ventricular pressure in millimeters of mercury (mmHg) by invasive angiography to non-invasively modelled left ventricular pressure by cardiac magnetic resonance imaging. The agreement will be tested by Bland-Altman plots..

Time frame

30 days

Secondary outcomes

Prognostic relevance of left ventricular pressures measured by cardiac MRI

Is cardiovascular magnetic resonance modelled left ventricular pressure in millimeters of mercury (mmHg) associated with MACE events including re-hospitalization, stroke, myocardial infarction and death. Association between pressure measurements and MACE will be tested by Cox proportional hazards regression and Kaplan-Meier survival analysis.

Time frame

Ten years

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of East Anglia

Lead sponsor

Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)

Collaborator

Source ClinicalTrials.gov

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