UK Heart Failure With Preserved Ejection Fraction
UK HFpEF
1 other identifier
observational
10,000
1 country
26
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2022
Longer than P75 for all trials
26 active sites
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
First Submitted
Initial submission to the registry
May 26, 2022
CompletedFirst Posted
Study publicly available on registry
July 1, 2022
CompletedStudy Start
First participant enrolled
October 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2037
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2037
May 6, 2025
May 1, 2025
14.7 years
May 26, 2022
May 1, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Identification of distinct subgroups of HFpEF
Identify distinct subgroups of HFpEF based on disease mechanisms, clinical factors and outcomes
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
10 years
Improve risk stratification of HFpEF
Identify and improve risk stratification models for HFpEF patients
10 years
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
- Known idiopathic, heritable or drug-induced pulmonary arterial hypertension
- Heart transplantation or ventricular assist device
- Complex congenital heart disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Manchester University NHS Foundation Trustlead
- Pumping Marvellous Foundationcollaborator
- British Society for Heart Failurecollaborator
- National Institute for Health Research, United Kingdomcollaborator
- British Heart Foundation Data Science Centrecollaborator
Study Sites (26)
Cwm Taf Morgannwg University Health Board
Abercynon, CF31 1RQ, United Kingdom
Buckinghamshire Healthcare NHS Trust
Aylesbury, HP21 8AL, United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2GW, United Kingdom
Broomfield Hospital
Chelmsford, CM1 7ET, United Kingdom
NHS Tayside
Dundee, DD2 1UB, United Kingdom
Glasgow Royal Infirmary
Glasgow, G4 0SF, United Kingdom
West Suffolk NHS Foundation Trust
Ipswich, IP33 2QZ, United Kingdom
Kettering General Hospital
Kettering, NN16 8UZ, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, LS1 3EX, United Kingdom
University Hospitals of Leicester NHS Foundation Trust
Leicester, LE5 4PW, United Kingdom
Barnet Hospital
London, EN5 3DJ, United Kingdom
Guys and St. Thomas' NHS Foundation Trust
London, SE1 7EH, United Kingdom
Imperial College Healthcare NHS Trust
London, W2 1NY, United Kingdom
Manchester University NHS Foundation trust
Manchester, M13 9WU, United Kingdom
The James Cook University Hospital
Middlesbrough, TS4 3BW, United Kingdom
Northumbria Healthcare NHS Foundation Trust
Newcastle upon Tyne, NE23 6NZ, United Kingdom
Norfolk & Norwich University Hospitals NHS Foundation Trust
Norwich, NR4 7UY, United Kingdom
George Eliot Hospital
Nuneaton, CV10 7DJ, United Kingdom
North West Anglia NHS Foundation Trust
Peterborough, PE3 9GZ, United Kingdom
University Hospitals Dorset NHS Foundation Trust
Poole, BH15 2JB, United Kingdom
Betsi Cadwaldr University Health Board
Rhyl, LL18 5UJ, United Kingdom
Salisbury NHS Foundation Trust
Salisbury, SP2 8BJ, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S5 7AU, United Kingdom
University Hospital of North Tees
Stockton-on-Tees, TS19 8PE, United Kingdom
South Tyneside & Sunderland NHS Foundation Trust
Sunderland, SR4 7TP, United Kingdom
Southend University Hospital
Westcliff-on-Sea, SS0 0RY, United Kingdom
Related Publications (5)
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.
PMID: 16855265BACKGROUNDLewis 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.
PMID: 29050567BACKGROUNDPitt 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.
PMID: 24716680BACKGROUNDSolomon 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.
PMID: 31475794BACKGROUNDUK 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.
PMID: 37827557DERIVED
Biospecimen
Blood sampling will be performed for DNA extraction, plasma and serum. The total volume of blood collected will be up to 50 ml. Samples will undergo initial processing and storage at sites, before being transferred to a central repository (NIHR National Biosample Centre). Further details regarding collection, initial processing and storage, and transfer of samples to the central repository will be provided in the Study Reference Manual.
Study Officials
- STUDY CHAIR
Chris Miller, MBChB FRCP
Manchester University NHS Foundation Trust
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2022
First Posted
July 1, 2022
Study Start
October 7, 2022
Primary Completion (Estimated)
June 1, 2037
Study Completion (Estimated)
June 1, 2037
Last Updated
May 6, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Within the life time of the study
- Access Criteria
- Release of data or samples to investigators or organisations requesting access, whether they reside within or outside the UK, will be covered by Data and/or Material Transfer Agreements. The Agreements are legally binding documents that will regulate the use of data and/or samples to ensure that standards are maintained.
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.