Heart Failure With Preserved Ejection Fraction (HFpEF)UK HFpEFNCT05441839
UK Heart Failure With Preserved Ejection Fraction
An observational study of Heart Failure With Preserved Ejection Fraction (HFpEF), run by Manchester University NHS Foundation Trust at 26 sites in United Kingdom.
Trial summary
Heart failure occurs when the heart is no longer able to pump blood around the body properly. It can cause breathlessness, swollen feet and ankles, and tiredness. In about half of patients with heart failure, one measure of the heart's pumping function, called the 'ejection fraction', is normal. 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 (HFpEF)
- How many people
- 10,000 participants
- Where
- 26 sitesUnited Kingdom
- Study dates
- 7 Oct 2022to 1 Jun 2037
- 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: All individuals will be considered for inclusion in this study regardless of age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion and belief, sex, and sexual orientation, except where the study inclusion and exclusion criteria explicitly state otherwise.
Who may be able to join
- Written informed consent
- Diagnosis of HFpEF by a cardiologist with HF expertise, or a primary care physician with HF expertise, or a heart failure nurse
- Natriuretic peptide levels measured
Who cannot join
- LV EF < 40% (at screening or any previous measurement)
- Known infiltrative cardiomyopathy (e.g., amyloid, sarcoid, lymphoma, endomyocardial fibrosis)
- Known active myocarditis, constrictive pericarditis, or cardiac tamponade
- Known genetic hypertrophic cardiomyopathy or obstructive hypertrophic cardiomyopathy
- Known arrhythmogenic right ventricular cardiomyopathy
- Known severe primary valvular heart disease
Show all 9Show fewer
- Known idiopathic, heritable or drug-induced pulmonary arterial hypertension
- Heart transplantation or ventricular assist device
- Complex congenital heart disease
Trial locations and contacts
26 sites in 1 country. Contact the study team or a site near you to ask about taking part.
26 sites in 1 country
United Kingdom26 sites, 26 recruiting
- Recruiting
Cwm Taf Morgannwg University Health Board
Abercynon, CF31 1RQ
Rhys Williams, 0161 291 4075, Lisa.Roche2@wales.nhs.uk
- Recruiting
Buckinghamshire Healthcare NHS Trust
Aylesbury, HP21 8AL
Mayooran Shanmuganathan, 0161 291 4075, josephine.chaplin@nhs.net
- Recruiting
University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2GW
Peysh Patel, 0161 291 4075, Annette.Nilsson@uhb.nhs.uk
- Recruiting
Broomfield Hospital
Chelmsford, CM1 7ET
Rachael Arnold, 0161 291 4075, rachael.arnold@nhs.net
- Recruiting
NHS Tayside
Dundee, DD2 1UB
Ify Mordi, 0161 291 4075, tay.crc@nhs.scot
- Recruiting
Glasgow Royal Infirmary
Glasgow, G4 0SF
Prof M Petrie, 0161 291 4075, Andrew.Dougherty@ggc.scot.nhs.uk
- Recruiting
West Suffolk NHS Foundation Trust
Ipswich, IP33 2QZ
Justin Zaman, 0161 291 4075, Joanne.Kellett@wsh.nhs.uk
- Recruiting
Kettering General Hospital
Kettering, NN16 8UZ
Mohsin Farooq, 0161 291 4075, parizade.raymode@nhs.net
- Recruiting
Leeds Teaching Hospitals NHS Trust
Leeds, LS1 3EX
Kate Gatenby, 0161 291 4075, emma.grant26@nhs.net
- Recruiting
University Hospitals of Leicester NHS Foundation Trust
Leicester, LE5 4PW
Prof Squire, 0161 291 4075, RIContract@uhl-tr.nhs.uk
- Recruiting
Barnet Hospital
London, EN5 3DJ
Ameet Bakhai, 0161 291 4075, alice.fisher8@nhs.net
- Recruiting
Guys and St. Thomas' NHS Foundation Trust
London, SE1 7EH
Rebekah Schiff, 0161 291 4075, AgeingandHealthResearch@gstt.nhs.uk
- Recruiting
Imperial College Healthcare NHS Trust
London, W2 1NY
Prof Jamil Mayet, 0161 291 4075, umaymah.sharif@nhs.net
- Recruiting
Manchester University NHS Foundation trust
Manchester, M13 9WU
Fardad Soltani 0161 291 3223, 0161 291 3223, fardad.soltani@mft.nhs.uk
- Recruiting
The James Cook University Hospital
Middlesbrough, TS4 3BW
Michael Chapman, 0161 291 4075, rachel.kipling@nhs.net
- Recruiting
Northumbria Healthcare NHS Foundation Trust
Newcastle upon Tyne, NE23 6NZ
David Ripley, 0161 291 4075, hayley.mckie@northumbria-healthcare.nhs.uk
- Recruiting
Norfolk & Norwich University Hospitals NHS Foundation Trust
Norwich, NR4 7UY
Pankaj Garg, 0161 291 4075, laura.staff@nnuh.nhs.uk
- Recruiting
George Eliot Hospital
Nuneaton, CV10 7DJ
Asok Venkatamaran, 0161 291 4075, rosemary.musanhu@nhs.net
- Recruiting
North West Anglia NHS Foundation Trust
Peterborough, PE3 9GZ
Daniele Arcoria, 0161 291 4075, nwangliaft.pchemedresearch@nhs.net
- Recruiting
University Hospitals Dorset NHS Foundation Trust
Poole, BH15 2JB
Raj Chahal, 0161 291 4075, Tanith.Changuion@uhd.nhs.uk
- Recruiting
Betsi Cadwaldr University Health Board
Rhyl, LL18 5UJ
Mohammad Aldwaik, 0161 291 4075, rachel.manley2@wales.nhs.uk
- Recruiting
Salisbury NHS Foundation Trust
Salisbury, SP2 8BJ
Tom Jackson, 0161 291 4075, fiona.trim@nhs.net
- Recruiting
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S5 7AU
Prof Al-Mohammad, 0161 291 4075, Samantha.walmsley@nhs.net
- Recruiting
University Hospital of North Tees
Stockton-on-Tees, TS19 8PE
Matthew Dewhurst, 0161 291 4075, emma.connell3@nhs.net
- Recruiting
South Tyneside & Sunderland NHS Foundation Trust
Sunderland, SR4 7TP
Alykhan Bandali, 0161 291 4075, karen.davidson17@nhs.net
- Recruiting
Southend University Hospital
Westcliff-on-Sea, SS0 0RY
Swapna Kunhunny, 0161 291 4075, s.kunhunny@nhs.net
About this study
Official title: UK Heart Failure With Preserved Ejection Fraction Registry
Heart failure occurs when the heart is no longer able to pump blood around the body properly. It can cause breathlessness, swollen feet and ankles, and tiredness. In about half of patients with heart failure, one measure of the heart's pumping function, called the 'ejection fraction', is normal. This type of heart failure is called heart failure with preserved ejection fraction, or HFpEF.
HFpEF remains poorly understood. It is not clear why some people develop HFpEF, or what determines the severity of the condition. Treatment options may be limited.
UK HFpEF is a study that aims to gain a better understanding of why people develop HFpEF, develop better tests to diagnosis it, identify and test new treatments, and follow the health of the people taking part over many years.
Read the detailed description
Approximately half of patients with heart failure have a normal, or preserved, left ventricular ejection fraction (HFpEF) (Owen et al, 2006). Rather than being a single diagnosis, it has become clear that HFpEF represents a heterogeneous syndrome involving a range of pathophysiological mechanisms, clinical factors and outcomes (Lewis et al, 2017). However, to-date, HFpEF has generally been considered as a single disease entity. Several high profile phase III trials in HFpEF have shown potentially impressive efficacy in some subgroups of patients, but failed to prove significance over entire cohorts (Pitt et al, 2014) (Solomon et al, 2019). This is likely due to the 'one-size-fits-all' approach taken, with insufficient stratification of the various underlying disease mechanisms.
The large and rapidly growing burden that HFpEF places on our healthcare systems mean there is a pressing need to better understand HFpEF and improve the management of patients with it. The recurrent lack of benefit of the one-size-fits-all approach mandates a new, personalised approach.
The UK HFpEF registry will be a key platform for collaborative UK clinical and translational HFpEF research. The aim is that multiple centres will collaborate and contribute patients such that the registry will provide deep phenotyping, linked to outcomes, in, ultimately, many thousands of patients. This will enable, for example, machine learning techniques to be applied at scale in order to reclassify HFpEF more powerfully. It will provide a platform for the development of diagnostics specific to the different HFpEF subgroups, and for more effective trials that will target groups of patients in whom new, repurposed or previously discarded treatments are expected to be effective. Moreover, it will provide cohorts of patients readily available for recruitment, with linkage in place for outcomes. It could be used to leverage commercial funding and participation, facilitated by simplified, single-point access for industry. It will enable scaled investigation aimed at understanding causes of HFpEF, improving risk stratification and providing better care.
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of distinct subgroups of HFpEF
Identify distinct subgroups of HFpEF based on disease mechanisms, clinical factors and outcomes
Measured: 10 years
Improve understanding of the causes of HFpEF
Improve the understanding of the cause of HFpEF to provide the basis for developing and evaluating new therapies and diagnostics
Measured: 10 years
Improve risk stratification of HFpEF
Identify and improve risk stratification models for HFpEF patients
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start7 Oct 2022
- Primary completion1 Jun 2037 (estimated)
- Study completion1 Jun 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Preserved Ejection Fraction (HFpEF)Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- Pumping Marvellous Foundation, British Society for Heart Failure, National Institute for Health Research, United Kingdom, British Heart Foundation Data Science Centre
- Responsible party
- Sponsor
- Investigators
- Chris Miller, MBChB FRCP, Study chair, Manchester University NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05441839
- Sponsor's protocol ID
- B01434
- Acronym
- UK HFpEF
- Status last verified
- May 2025
- First submitted
- 26 May 2022
- Last updated
- 6 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participants will be asked to provide consent for pseudonymised study data, including, for example, individual patient-level data, scans and any other study data, to be shared for research purposes with investigators or organisations, including independent commercial organisations ('industry'), in the United Kingdom or overseas, including outside of the European Economic Area and in the United States of America. Participant personal details such as name, address, date of birth, will not be shared. Requests for access to the data will be managed by the Executive Steering Committee. Release of data to investigators or organisations requesting access, whether they reside within or outside the UK, will be covered by a Data Transfer Agreement. The Data Transfer Agreement is a legally binding document that will regulate the use of data to ensure that standards are maintained.
Publications
Owan TE, Hodge DO, Herges RM, Jacobsen SJ, Roger VL, Redfield MM. Trends in prevalence and outcome of heart failure with preserved ejection fraction. N Engl J Med. 2006 Jul 20;355(3):251-9. doi: 10.1056/NEJMoa052256.
PubMed 16855265Lewis GA, Schelbert EB, Williams SG, Cunnington C, Ahmed F, McDonagh TA, Miller CA. Biological Phenotypes of Heart Failure With Preserved Ejection Fraction. J Am Coll Cardiol. 2017 Oct 24;70(17):2186-2200. doi: 10.1016/j.jacc.2017.09.006.
PubMed 29050567Pitt B, Pfeffer MA, Assmann SF, Boineau R, Anand IS, Claggett B, Clausell N, Desai AS, Diaz R, Fleg JL, Gordeev I, Harty B, Heitner JF, Kenwood CT, Lewis EF, O'Meara E, Probstfield JL, Shaburishvili T, Shah SJ, Solomon SD, Sweitzer NK, Yang S, McKinlay SM; TOPCAT Investigators. Spironolactone for heart failure with preserved ejection fraction. N Engl J Med. 2014 Apr 10;370(15):1383-92. doi: 10.1056/NEJMoa1313731.
PubMed 24716680Solomon SD, McMurray JJV, Anand IS, Ge J, Lam CSP, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Redfield MM, Rouleau JL, van Veldhuisen DJ, Zannad F, Zile MR, Desai AS, Claggett B, Jhund PS, Boytsov SA, Comin-Colet J, Cleland J, Dungen HD, Goncalvesova E, Katova T, Kerr Saraiva JF, Lelonek M, Merkely B, Senni M, Shah SJ, Zhou J, Rizkala AR, Gong J, Shi VC, Lefkowitz MP; PARAGON-HF Investigators and Committees. Angiotensin-Neprilysin Inhibition in Heart Failure with Preserved Ejection Fraction. N Engl J Med. 2019 Oct 24;381(17):1609-1620. doi: 10.1056/NEJMoa1908655. Epub 2019 Sep 1.
PubMed 31475794UK HFpEF Collaborative Group. Rationale and design of the United Kingdom Heart Failure with Preserved Ejection Fraction Registry. Heart. 2024 Feb 12;110(5):359-365. doi: 10.1136/heartjnl-2023-323049.
PubMed 37827557
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UK Heart Failure With Preserved Ejection Fraction Registry
- ClinicalTrials.gov ID
- NCT05441839
- Acronym / sponsor ID
- UK HFpEF / B01434
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Collaborators
- Pumping Marvellous Foundation, British Society for Heart Failure, National Institute for Health Research, United Kingdom, British Heart Foundation Data Science Centre
- Study start
- 7 Oct 2022 (actual)
- Primary completion
- 1 Jun 2037 (estimated)
- Study completion
- 1 Jun 2037 (estimated)
- First posted
- 1 Jul 2022 (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 occurs when the heart is no longer able to pump blood around the body properly. It can cause breathlessness, swollen feet and ankles, and tiredness. In about half of patients with heart failure, one measure of the heart's pumping function, called the 'ejection fraction', is normal. This type of heart failure is called heart failure with preserved ejection fraction, or HFpEF.
HFpEF remains poorly understood. It is not clear why some people develop HFpEF, or what determines the severity of the condition. Treatment options may be limited.
UK HFpEF is a study that aims to gain a better understanding of why people develop HFpEF, develop better tests to diagnosis it, identify and test new treatments, and follow the health of the people taking part over many years.
Detailed description
Approximately half of patients with heart failure have a normal, or preserved, left ventricular ejection fraction (HFpEF) (Owen et al, 2006). Rather than being a single diagnosis, it has become clear that HFpEF represents a heterogeneous syndrome involving a range of pathophysiological mechanisms, clinical factors and outcomes (Lewis et al, 2017). However, to-date, HFpEF has generally been considered as a single disease entity. Several high profile phase III trials in HFpEF have shown potentially impressive efficacy in some subgroups of patients, but failed to prove significance over entire cohorts (Pitt et al, 2014) (Solomon et al, 2019). This is likely due to the 'one-size-fits-all' approach taken, with insufficient stratification of the various underlying disease mechanisms.
The large and rapidly growing burden that HFpEF places on our healthcare systems mean there is a pressing need to better understand HFpEF and improve the management of patients with it. The recurrent lack of benefit of the one-size-fits-all approach mandates a new, personalised approach.
The UK HFpEF registry will be a key platform for collaborative UK clinical and translational HFpEF research. The aim is that multiple centres will collaborate and contribute patients such that the registry will provide deep phenotyping, linked to outcomes, in, ultimately, many thousands of patients. This will enable, for example, machine learning techniques to be applied at scale in order to reclassify HFpEF more powerfully. It will provide a platform for the development of diagnostics specific to the different HFpEF subgroups, and for more effective trials that will target groups of patients in whom new, repurposed or previously discarded treatments are expected to be effective. Moreover, it will provide cohorts of patients readily available for recruitment, with linkage in place for outcomes. It could be used to leverage commercial funding and participation, facilitated by simplified, single-point access for industry. It will enable scaled investigation aimed at understanding causes of HFpEF, improving risk stratification and providing better care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All individuals will be considered for inclusion in this study regardless of age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion and belief, sex, and sexual orientation, except where the study inclusion and exclusion criteria explicitly state otherwise.
Key inclusion criteria (3 listed)
- Written informed consent
- Diagnosis of HFpEF by a cardiologist with HF expertise, or a primary care physician with HF expertise, or a heart failure nurse
- Natriuretic peptide levels measured
Key exclusion criteria (9 listed)
- LV EF < 40% (at screening or any previous measurement)
- Known infiltrative cardiomyopathy (e.g., amyloid, sarcoid, lymphoma, endomyocardial fibrosis)
- Known active myocarditis, constrictive pericarditis, or cardiac tamponade
- Known genetic hypertrophic cardiomyopathy or obstructive hypertrophic cardiomyopathy
- Known arrhythmogenic right ventricular cardiomyopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of distinct subgroups of HFpEF
Time frame: 10 years
Identify distinct subgroups of HFpEF based on disease mechanisms, clinical factors and outcomes
Improve understanding of the causes of HFpEF
Time frame: 10 years
Improve the understanding of the cause of HFpEF to provide the basis for developing and evaluating new therapies and diagnostics
Improve risk stratification of HFpEF
Time frame: 10 years
Identify and improve risk stratification models for HFpEF patients
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 6 May 2025.
- Background: PubMed 16855265Owan TE, Hodge DO, Herges RM, Jacobsen SJ, Roger VL, Redfield MM. Trends in prevalence and outcome of heart failure with preserved ejection fraction. N Engl J Med. 2006 Jul 20;355(3):251-9. doi: 10.1056/NEJMoa052256.
- Background: PubMed 29050567Lewis GA, Schelbert EB, Williams SG, Cunnington C, Ahmed F, McDonagh TA, Miller CA. Biological Phenotypes of Heart Failure With Preserved Ejection Fraction. J Am Coll Cardiol. 2017 Oct 24;70(17):2186-2200. doi: 10.1016/j.jacc.2017.09.006.
- Background: PubMed 24716680Pitt B, Pfeffer MA, Assmann SF, Boineau R, Anand IS, Claggett B, Clausell N, Desai AS, Diaz R, Fleg JL, Gordeev I, Harty B, Heitner JF, Kenwood CT, Lewis EF, O'Meara E, Probstfield JL, Shaburishvili T, Shah SJ, Solomon SD, Sweitzer NK, Yang S, McKinlay SM; TOPCAT Investigators. Spironolactone for heart failure with preserved ejection fraction. N Engl J Med. 2014 Apr 10;370(15):1383-92. doi: 10.1056/NEJMoa1313731.
- Background: PubMed 31475794Solomon SD, McMurray JJV, Anand IS, Ge J, Lam CSP, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Redfield MM, Rouleau JL, van Veldhuisen DJ, Zannad F, Zile MR, Desai AS, Claggett B, Jhund PS, Boytsov SA, Comin-Colet J, Cleland J, Dungen HD, Goncalvesova E, Katova T, Kerr Saraiva JF, Lelonek M, Merkely B, Senni M, Shah SJ, Zhou J, Rizkala AR, Gong J, Shi VC, Lefkowitz MP; PARAGON-HF Investigators and Committees. Angiotensin-Neprilysin Inhibition in Heart Failure with Preserved Ejection Fraction. N Engl J Med. 2019 Oct 24;381(17):1609-1620. doi: 10.1056/NEJMoa1908655. Epub 2019 Sep 1.
- Derived from this study: PubMed 37827557UK HFpEF Collaborative Group. Rationale and design of the United Kingdom Heart Failure with Preserved Ejection Fraction Registry. Heart. 2024 Feb 12;110(5):359-365. doi: 10.1136/heartjnl-2023-323049.
- Individual participant dataSharing planned: Yes. Participants will be asked to provide consent for pseudonymised study data, including, for example, individual patient-level data, scans and any other study data, to be shared for research purposes with investigators or organisations, including independent commercial organisations ('industry'), in the United Kingdom or overseas, including outside of the European Economic Area and in the United States of America. Participant personal details such as name, address, date of birth, will not be shared. Requests for access to the data will be managed by the Executive Steering Committee. Release of data to investigators or organisations requesting access, whether they reside within or outside the UK, will be covered by a Data Transfer Agreement. The Data Transfer Agreement is a legally binding document that will regulate the use of data to ensure that standards are maintained.
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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.
Chris Miller, MBChB FRCP study chair
Manchester University NHS Foundation Trust
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure With Preserved Ejection Fraction (HFpEF), run by Manchester University NHS Foundation Trust at 26 sites in United Kingdom.
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 3 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Fardad Soltani, MBChB MRCP (0161 291 3223, fardad.soltani@mft.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of distinct subgroups of HFpEF (time frame: 10 years). The study lists 3 primary outcomes in all. 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 NCT05441839, which also lists 5 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 6 May 2025.