UK Heart Failure With Preserved Ejection Fraction (UK HFpEF)

May 1, 2025 updated by: Manchester University NHS Foundation Trust

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • Abercynon, United Kingdom, CF31 1RQ
        • Recruiting
        • Cwm Taf Morgannwg University Health Board
        • Contact:
      • Aylesbury, United Kingdom, HP21 8AL
        • Recruiting
        • Buckinghamshire Healthcare NHS Trust
        • Contact:
      • Birmingham, United Kingdom, B15 2GW
        • Recruiting
        • University Hospitals Birmingham NHS Foundation Trust
        • Contact:
      • Chelmsford, United Kingdom, CM1 7ET
        • Recruiting
        • Broomfield Hospital
        • Contact:
      • Dundee, United Kingdom, DD2 1UB
        • Recruiting
        • NHS Tayside
        • Contact:
      • Glasgow, United Kingdom, G4 0SF
      • Ipswich, United Kingdom, IP33 2QZ
        • Recruiting
        • West Suffolk NHS Foundation Trust
        • Contact:
      • Kettering, United Kingdom, NN16 8UZ
        • Recruiting
        • Kettering General Hospital
        • Contact:
      • Leeds, United Kingdom, LS1 3EX
        • Recruiting
        • Leeds Teaching Hospitals NHS Trust
        • Contact:
      • Leicester, United Kingdom, LE5 4PW
        • Recruiting
        • University Hospitals of Leicester NHS Foundation Trust
        • Contact:
      • London, United Kingdom, W2 1NY
        • Recruiting
        • Imperial College Healthcare NHS Trust
        • Contact:
      • London, United Kingdom, EN5 3DJ
        • Recruiting
        • Barnet Hospital
        • Contact:
      • London, United Kingdom, SE1 7EH
      • Manchester, United Kingdom, M13 9WU
        • Recruiting
        • Manchester University NHS Foundation Trust
        • Contact:
      • Middlesborough, United Kingdom, TS4 3BW
        • Recruiting
        • The James Cook University Hospital
        • Contact:
      • Newcastle upon Tyne, United Kingdom, NE23 6NZ
      • Norwich, United Kingdom, NR4 7UY
        • Recruiting
        • Norfolk & Norwich University Hospitals NHS Foundation Trust
        • Contact:
      • Nuneaton, United Kingdom, CV10 7DJ
        • Recruiting
        • George Eliot Hospital
        • Contact:
      • Peterborough, United Kingdom, PE3 9GZ
      • Poole, United Kingdom, BH15 2JB
        • Recruiting
        • University Hospitals Dorset NHS Foundation Trust
        • Contact:
      • Rhyl, United Kingdom, LL18 5UJ
        • Recruiting
        • Betsi Cadwaldr University Health Board
        • Contact:
      • Salisbury, United Kingdom, SP2 8BJ
        • Recruiting
        • Salisbury Nhs Foundation Trust
        • Contact:
      • Sheffield, United Kingdom, S5 7AU
        • Recruiting
        • Sheffield Teaching Hospitals NHS Foundation Trust
        • Contact:
      • Stockton-on-Tees, United Kingdom, TS19 8PE
        • Recruiting
        • University Hospital of North Tees
        • Contact:
      • Sunderland, United Kingdom, SR4 7TP
        • Recruiting
        • South Tyneside & Sunderland NHS Foundation Trust
        • Contact:
      • Westcliff-on-Sea, United Kingdom, SS0 0RY
        • Recruiting
        • Southend University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  1. Written informed consent
  2. Diagnosis of HFpEF by a cardiologist with HF expertise, or a primary care physician with HF expertise, or a heart failure nurse
  3. Natriuretic peptide levels measured

Exclusion Criteria:

  1. LV EF < 40% (at screening or any previous measurement)
  2. Known infiltrative cardiomyopathy (e.g., amyloid, sarcoid, lymphoma, endomyocardial fibrosis)
  3. Known active myocarditis, constrictive pericarditis, or cardiac tamponade
  4. Known genetic hypertrophic cardiomyopathy or obstructive hypertrophic cardiomyopathy
  5. Known arrhythmogenic right ventricular cardiomyopathy
  6. Known severe primary valvular heart disease
  7. Known idiopathic, heritable or drug-induced pulmonary arterial hypertension
  8. Heart transplantation or ventricular assist device
  9. Complex congenital heart disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of distinct subgroups of HFpEF
Time Frame: 10 years
Identify distinct subgroups of HFpEF based on disease mechanisms, clinical factors and outcomes
10 years
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
10 years
Improve risk stratification of HFpEF
Time Frame: 10 years
Identify and improve risk stratification models for HFpEF patients
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Manchester University NHS Foundation Trust

Collaborators

Pumping Marvellous Foundation
British Society for Heart Failure
NIHR National Biosample Centre
British Heart Foundation Data Science Centre

Investigators

  • Study Chair: Chris Miller, MBChB FRCP, Manchester University NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2022

Primary Completion (Estimated)

June 1, 2037

Study Completion (Estimated)

June 1, 2037

Study Registration Dates

First Submitted

May 26, 2022

First Submitted That Met QC Criteria

June 28, 2022

First Posted (Actual)

July 1, 2022

Study Record Updates

Last Update Posted (Actual)

May 6, 2025

Last Update Submitted That Met QC Criteria

May 1, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B01434

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Within the life time of the study

IPD Sharing 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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