UK Heart Failure With Preserved Ejection Fraction

NCT ID: NCT05441839

Last Updated: 2025-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-07

Study Completion Date

2037-06-01

Brief Summary

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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

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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.

Conditions

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Heart Failure With Preserved Ejection Fraction (HFpEF)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pumping Marvellous Foundation

UNKNOWN

Sponsor Role collaborator

British Society for Heart Failure

UNKNOWN

Sponsor Role collaborator

National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role collaborator

British Heart Foundation Data Science Centre

UNKNOWN

Sponsor Role collaborator

Manchester University NHS Foundation Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chris Miller, MBChB FRCP

Role: STUDY_CHAIR

Manchester University NHS Foundation Trust

Locations

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Cwm Taf Morgannwg University Health Board

Abercynon, , United Kingdom

Site Status RECRUITING

Buckinghamshire Healthcare NHS Trust

Aylesbury, , United Kingdom

Site Status RECRUITING

University Hospitals Birmingham NHS Foundation Trust

Birmingham, , United Kingdom

Site Status RECRUITING

Broomfield Hospital

Chelmsford, , United Kingdom

Site Status RECRUITING

NHS Tayside

Dundee, , United Kingdom

Site Status RECRUITING

Glasgow Royal Infirmary

Glasgow, , United Kingdom

Site Status RECRUITING

West Suffolk NHS Foundation Trust

Ipswich, , United Kingdom

Site Status RECRUITING

Kettering General Hospital

Kettering, , United Kingdom

Site Status RECRUITING

Leeds Teaching Hospitals NHS Trust

Leeds, , United Kingdom

Site Status RECRUITING

University Hospitals of Leicester NHS Foundation Trust

Leicester, , United Kingdom

Site Status RECRUITING

Barnet Hospital

London, , United Kingdom

Site Status RECRUITING

Guys and St. Thomas' NHS Foundation Trust

London, , United Kingdom

Site Status RECRUITING

Imperial College Healthcare NHS Trust

London, , United Kingdom

Site Status RECRUITING

Manchester University NHS Foundation trust

Manchester, , United Kingdom

Site Status RECRUITING

The James Cook University Hospital

Middlesbrough, , United Kingdom

Site Status RECRUITING

Northumbria Healthcare NHS Foundation Trust

Newcastle upon Tyne, , United Kingdom

Site Status RECRUITING

Norfolk & Norwich University Hospitals NHS Foundation Trust

Norwich, , United Kingdom

Site Status RECRUITING

George Eliot Hospital

Nuneaton, , United Kingdom

Site Status RECRUITING

North West Anglia NHS Foundation Trust

Peterborough, , United Kingdom

Site Status RECRUITING

University Hospitals Dorset NHS Foundation Trust

Poole, , United Kingdom

Site Status RECRUITING

Betsi Cadwaldr University Health Board

Rhyl, , United Kingdom

Site Status RECRUITING

Salisbury NHS Foundation Trust

Salisbury, , United Kingdom

Site Status RECRUITING

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, , United Kingdom

Site Status RECRUITING

University Hospital of North Tees

Stockton-on-Tees, , United Kingdom

Site Status RECRUITING

South Tyneside & Sunderland NHS Foundation Trust

Sunderland, , United Kingdom

Site Status RECRUITING

Southend University Hospital

Westcliff-on-Sea, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Fardad Soltani, MBChB MRCP

Role: CONTACT

0161 291 3223

Lucy Priestner

Role: CONTACT

0044 161 291 3244

Facility Contacts

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Rhys Williams

Role: primary

0161 291 4075

Mayooran Shanmuganathan

Role: primary

0161 291 4075

Peysh Patel

Role: primary

0161 291 4075

Rachael Arnold

Role: primary

0161 291 4075

Ify Mordi

Role: primary

0161 291 4075

Prof M Petrie

Role: primary

0161 291 4075

Justin Zaman

Role: primary

0161 291 4075

Mohsin Farooq

Role: primary

0161 291 4075

Kate Gatenby

Role: primary

0161 291 4075

Prof Squire

Role: primary

0161 291 4075

Ameet Bakhai

Role: primary

0161 291 4075

Rebekah Schiff

Role: primary

0161 291 4075

Prof Jamil Mayet

Role: primary

0161 291 4075

Fardad Soltani 0161 291 3223

Role: primary

0161 291 3223

Michael Chapman

Role: primary

0161 291 4075

David Ripley

Role: primary

0161 291 4075

Pankaj Garg

Role: primary

0161 291 4075

Asok Venkatamaran

Role: primary

0161 291 4075

Daniele Arcoria

Role: primary

0161 291 4075

Raj Chahal

Role: primary

0161 291 4075

Mohammad Aldwaik

Role: primary

0161 291 4075

Tom Jackson

Role: primary

0161 291 4075

Prof Al-Mohammad

Role: primary

0161 291 4075

Matthew Dewhurst

Role: primary

0161 291 4075

Alykhan Bandali

Role: primary

0161 291 4075

Swapna Kunhunny

Role: primary

0161 291 4075

References

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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.

Reference Type BACKGROUND
PMID: 16855265 (View on PubMed)

Lewis 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.

Reference Type BACKGROUND
PMID: 29050567 (View on PubMed)

Pitt 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.

Reference Type BACKGROUND
PMID: 24716680 (View on PubMed)

Solomon 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.

Reference Type BACKGROUND
PMID: 31475794 (View on PubMed)

UK 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.

Reference Type DERIVED
PMID: 37827557 (View on PubMed)

Other Identifiers

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B01434

Identifier Type: -

Identifier Source: org_study_id

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