NCT05114785

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
69mo left

Started Jan 2022

Longer than P75 for all trials

Status
not yet recruiting

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 Progress44%
Jan 2022Jan 2032

First Submitted

Initial submission to the registry

September 28, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 10, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2032

Expected
Last Updated

January 5, 2022

Status Verified

November 1, 2021

Enrollment Period

4 years

First QC Date

September 28, 2021

Last Update Submit

December 13, 2021

Conditions

Heart Failure With Preserved Ejection FractionHeart Diseases

Keywords

Heart failurehemodynamicsmagnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

  • 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..

    30 days

Secondary Outcomes (1)

  • Prognostic relevance of left ventricular pressures measured by cardiac MRI

    Ten years

Study Arms (2)

HFpEF group

Suspected HFpEF group: 80 patients will be recruited with history of dyspnoea, LV ejection fraction ≥ 50%, raised NTproBNP

Diagnostic Test: Multi Parametric Cardiac Magnetic Resonance

Control group

20 patients with suspected CAD but with no dyspnoea and normal echocardiogram.

Diagnostic Test: Multi Parametric Cardiac Magnetic Resonance

Interventions

Multi Parametric Cardiac Magnetic ResonanceDIAGNOSTIC_TEST

Research based Cardiac MRI evaluation to determine cardiovascular haemodynamics

Control groupHFpEF group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* Suspected heart failure patients * Suspected coronary artery disease patients

You may qualify if:

  • 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).

You may not qualify if:

  • 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).
  • Previous medical history of EF \<50%
  • Pregnancy
  • The extended observational arm of the study will have wider eligibility criteria
  • \- Patients undergoing cardiac MRI for clinical indications irrespective of EF

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Bana A, Li R, Mehmood Z, Rogers C, Grafton-Clarke C, Bali T, Hall D, Jamil M, Ramachenderam L, Dudhiya U, Spohr H, Underwood V, Girling R, Kasmai B, Nair S, Matthews G, Garg P. Does CMR improve aetiological sub-phenotyping beyond echocardiography in patients with elevated LV filling pressure? A prospective registry study (PREFER-CMR). BMJ Open. 2026 Jan 14;16(1):e102836. doi: 10.1136/bmjopen-2025-102836.

    PMID: 41535077DERIVED

  • Grafton-Clarke C, Assadi H, Li R, Mehmood Z, Hall R, Matthews G, Tsampasian V, Alabed S, Kasmai B, Staff L, Curtin J, Yashoda GK, Sun J, Nair S, Hewson D, Thampi K, Broncano J, Ricci F, Swoboda P, Swift AJ, Vassiliou VS, Geest RJV, Garg P. Four-dimensional flow provides incremental diagnostic value over echocardiography in aortic stenosis. Open Heart. 2025 May 7;12(1):e003081. doi: 10.1136/openhrt-2024-003081.

    PMID: 40340893DERIVED

  • Assadi HS, Zhao X, Matthews G, Li R, Broncano Cabrero J, Kasmai B, Alabed S, Royuela Del Val J, Spohr H, Gurung-Koney Y, Aung N, Nair S, Swift AJ, Vassiliou VS, Zhong L, Al-Mohammad A, van der Geest RJ, Swoboda PP, Plein S, Garg P. Cardiovascular magnetic resonance imaging markers of ageing: a multi-centre, cross-sectional cohort study. Eur Heart J Open. 2025 May 2;5(3):oeaf032. doi: 10.1093/ehjopen/oeaf032. eCollection 2025 May.

    PMID: 40322642DERIVED

  • Assadi H, Sawh C, Spohr H, Nelthorpe F, Nair S, Hughes M, Ashman D, Ryding A, Matthews G, Li R, Grafton-Clarke C, Mehmood Z, Al-Mohammad A, Kasmai B, Vassiliou VS, Garg P. Clinical relevance of aortic conduit and reservoir function. Open Heart. 2024 Aug 19;11(2):e002713. doi: 10.1136/openhrt-2024-002713.

    PMID: 39160086DERIVED

  • Assadi H, Alabed S, Li R, Matthews G, Karunasaagarar K, Kasmai B, Nair S, Mehmood Z, Grafton-Clarke C, Swoboda PP, Swift AJ, Greenwood JP, Vassiliou VS, Plein S, van der Geest RJ, Garg P. Development and validation of AI-derived segmentation of four-chamber cine cardiac magnetic resonance. Eur Radiol Exp. 2024 Jul 12;8(1):77. doi: 10.1186/s41747-024-00477-7.

    PMID: 38992116DERIVED

  • Mehmood Z, Assadi H, Grafton-Clarke C, Li R, Matthews G, Alabed S, Girling R, Underwood V, Kasmai B, Zhao X, Ricci F, Zhong L, Aung N, Petersen SE, Swift AJ, Vassiliou VS, Cavalcante J, Geest RJV, Garg P. Validation of 2D flow MRI for helical and vortical flows. Open Heart. 2024 Mar 8;11(1):e002451. doi: 10.1136/openhrt-2023-002451.

    PMID: 38458769DERIVED

MeSH Terms

Conditions

Heart DiseasesHeart Failure

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Pankaj Garg, MD

    University of East Anglia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pankaj Garg, MD

CONTACT

+441603591721p.garg@uea.ac.uk

Marcus D Flather, MBBS

CONTACT

m.flather@uea.ac.uk

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2021

First Posted

November 10, 2021

Study Start

January 1, 2022

Primary Completion

January 1, 2026

Study Completion (Estimated)

January 1, 2032

Last Updated

January 5, 2022

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will share

The dataset of this study are available at the discretion of the Principal Investigator on reasonable request.