Heart Failure With Preserved Ejection FractionPREFER-CMRNCT05114785
Heart Failure With Preserved Ejection Fraction: Evaluation and Recognition by CMR
An observational study of Heart Failure With Preserved Ejection Fraction and Heart Diseases, run by University of East Anglia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction, Heart Diseases
- What is being tested?
- Multi Parametric Cardiac Magnetic Resonance
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2022to Jan 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Suspected heart failure patients * Suspected coronary artery disease patients
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Marcus D Flather, MBBS contact
About this study
Official title: PReserved Ejection Fraction Evaluation and Recognition by Cardiac Magnetic Resonance
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.
Read the detailed description
Heart failure with preserved ejection fraction (HFpEF) is prevalent, increasing in incidence and has a poor prognosis. Accurate left ventricular (LV) haemodynamic assessment is needed to diagnose and manage patients with HFpEF. The reference method for assessment is an invasive study using catheters to measure intra-ventricular pressure but this is rarely done due to its invasive nature, high procedural costs and lack of expertise, despite the fact that haemodynamic guided therapy is associated with reduced re-hospitalisation and mortality. Non-invasive methods of LV haemodynamic assessment are inaccurate. The Investigators have developed an accurate four-dimensional flow cardiac magnetic resonance (4D flow CMR) protocol which is non-invasive and addresses the issues with existing practices to evaluate HFpEF. This observational-analytical study aims to assess the utility of a non-invasive 4D flow CMR protocol for haemodynamic assessment of HFpEF, to generate clinical data to support future clinical trials, clinical translation and patient benefit. This research study will involve generating a precise haemodynamic model using invasive and non-invasive data of prospectively recruited patients. This model will be also optimised in clinical patients with arrhythmias. Also, observational data will be collected to test the model's prognostic value.
- Being tested
- Multi Parametric Cardiac Magnetic Resonance
- Keywords
- Heart failure, hemodynamics, magnetic resonance imaging
- Medical subject headings
- Heart Diseases, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi Parametric Cardiac Magnetic ResonanceDiagnostic test
Research based Cardiac MRI evaluation to determine cardiovascular haemodynamics
| Study group | Role | What they receive |
|---|---|---|
| HFpEF group | Suspected HFpEF group: 80 patients will be recruited with history of dyspnoea, LV ejection fraction ≥ 50%, raised NTproBNP Receives: Diagnostic Test: Multi Parametric Cardiac Magnetic Resonance | |
| Control group | 20 patients with suspected CAD but with no dyspnoea and normal echocardiogram. Receives: Diagnostic Test: Multi Parametric Cardiac Magnetic Resonance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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..
Measured: 30 days
Secondary outcomes (1)
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.
Measured: Ten years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study startJan 2022 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of East Anglia
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
- Responsible party
- Sponsor
- Investigators
- Pankaj Garg, MD, Principal investigator, University of East Anglia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05114785
- Sponsor's protocol ID
- IRAS 301141
- Acronym
- PREFER-CMR
- Status last verified
- Nov 2021
- First submitted
- 28 Sep 2021
- Last updated
- 5 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The dataset of this study are available at the discretion of the Principal Investigator on reasonable request.
Publications
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.
PubMed 41535077Grafton-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.
PubMed 40340893Assadi 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.
PubMed 40322642Assadi 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.
PubMed 39160086Assadi 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.
PubMed 38992116Mehmood 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.
PubMed 38458769
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PReserved Ejection Fraction Evaluation and Recognition by Cardiac Magnetic Resonance
- ClinicalTrials.gov ID
- NCT05114785
- Acronym / sponsor ID
- PREFER-CMR / IRAS 301141
- Keywords
- Heart failure, hemodynamics, magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of East AngliaUniversity, hospital or other
- Collaborators
- Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
- Study start
- Jan 2022 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2032 (estimated)
- First posted
- 10 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Heart failure with preserved ejection fraction (HFpEF) is prevalent, increasing in incidence and has a poor prognosis. Accurate left ventricular (LV) haemodynamic assessment is needed to diagnose and manage patients with HFpEF. The reference method for assessment is an invasive study using catheters to measure intra-ventricular pressure but this is rarely done due to its invasive nature, high procedural costs and lack of expertise, despite the fact that haemodynamic guided therapy is associated with reduced re-hospitalisation and mortality. Non-invasive methods of LV haemodynamic assessment are inaccurate. The Investigators have developed an accurate four-dimensional flow cardiac magnetic resonance (4D flow CMR) protocol which is non-invasive and addresses the issues with existing practices to evaluate HFpEF. This observational-analytical study aims to assess the utility of a non-invasive 4D flow CMR protocol for haemodynamic assessment of HFpEF, to generate clinical data to support future clinical trials, clinical translation and patient benefit. This research study will involve generating a precise haemodynamic model using invasive and non-invasive data of prospectively recruited patients. This model will be also optimised in clinical patients with arrhythmias. Also, observational data will be collected to test the model's prognostic value.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFpEF group | – | Diagnostic Test: Multi Parametric Cardiac Magnetic ResonanceSuspected HFpEF group: 80 patients will be recruited with history of dyspnoea, LV ejection fraction ≥ 50%, raised NTproBNP |
| Control group | – | Diagnostic Test: Multi Parametric Cardiac Magnetic Resonance20 patients with suspected CAD but with no dyspnoea and normal echocardiogram. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Suspected heart failure patients * Suspected coronary artery disease patients
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (8 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi Parametric Cardiac Magnetic ResonanceResearch based Cardiac MRI evaluation to determine cardiovascular haemodynamics | Diagnostic test | Control group, HFpEF group |
Primary outcome
Left ventricular pressure measured by invasive angiography (reference method) and modelled by cardiovascular magnetic resonance imaging
Time frame: 30 days
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..
1 secondary outcome
Prognostic relevance of left ventricular pressures measured by cardiac MRI
Time frame: Ten years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
- Derived from this study: PubMed 41535077Bana 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.
- Derived from this study: PubMed 40340893Grafton-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.
- Derived from this study: PubMed 40322642Assadi 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.
- Derived from this study: PubMed 39160086Assadi 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.
- Derived from this study: PubMed 38992116Assadi 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.
- Derived from this study: PubMed 38458769Mehmood 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.
- Individual participant dataSharing planned: Yes. The dataset of this study are available at the discretion of the Principal Investigator on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marcus D Flather, MBBS contact
Pankaj Garg, MD principal investigator
University of East Anglia
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure With Preserved Ejection Fraction and Heart Diseases, run by University of East Anglia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pankaj Garg, MD (+441603591721, p.garg@uea.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular pressure measured by invasive angiography (reference method) and modelled by cardiovascular magnetic resonance imaging (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05114785, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2022.