UK Heart Failure With Preserved Ejection Fraction

Last updated: May 1, 2025
Sponsor: Manchester University NHS Foundation Trust
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Hyponatremia

Congestive Heart Failure

Treatment

N/A

Clinical Study ID

NCT05441839
B01434
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Written informed consent

  2. Diagnosis of HFpEF by a cardiologist with HF expertise, or a primary care physicianwith HF expertise, or a heart failure nurse

  3. Natriuretic peptide levels measured

Exclusion

Exclusion Criteria:

  1. LV EF < 40% (at screening or any previous measurement)

  2. Known infiltrative cardiomyopathy (e.g., amyloid, sarcoid, lymphoma, endomyocardialfibrosis)

  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 Design

Total Participants: 10000
Study Start date:
October 07, 2022
Estimated Completion Date:
June 01, 2037

Study 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.

Connect with a study center

  • Cwm Taf Morgannwg University Health Board

    Abercynon, CF31 1RQ
    United Kingdom

    Active - Recruiting

  • Buckinghamshire Healthcare NHS Trust

    Aylesbury, HP21 8AL
    United Kingdom

    Active - Recruiting

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, B15 2GW
    United Kingdom

    Active - Recruiting

  • Broomfield Hospital

    Chelmsford, CM1 7ET
    United Kingdom

    Active - Recruiting

  • NHS Tayside

    Dundee, DD2 1UB
    United Kingdom

    Active - Recruiting

  • Glasgow Royal Infirmary

    Glasgow, G4 0SF
    United Kingdom

    Active - Recruiting

  • West Suffolk NHS Foundation Trust

    Ipswich, IP33 2QZ
    United Kingdom

    Active - Recruiting

  • Kettering General Hospital

    Kettering, NN16 8UZ
    United Kingdom

    Active - Recruiting

  • Leeds Teaching Hospitals NHS Trust

    Leeds, LS1 3EX
    United Kingdom

    Active - Recruiting

  • University Hospitals of Leicester NHS Foundation Trust

    Leicester, LE5 4PW
    United Kingdom

    Active - Recruiting

  • Barnet Hospital

    London, EN5 3DJ
    United Kingdom

    Active - Recruiting

  • Guys and St. Thomas' NHS Foundation Trust

    London, SE1 7EH
    United Kingdom

    Active - Recruiting

  • Imperial College Healthcare NHS Trust

    London, W2 1NY
    United Kingdom

    Active - Recruiting

  • Manchester University NHS Foundation trust

    Manchester, M13 9WU
    United Kingdom

    Active - Recruiting

  • The James Cook University Hospital

    Middlesborough, TS4 3BW
    United Kingdom

    Active - Recruiting

  • Northumbria Healthcare NHS Foundation Trust

    Newcastle upon Tyne, NE23 6NZ
    United Kingdom

    Active - Recruiting

  • Norfolk & Norwich University Hospitals NHS Foundation Trust

    Norwich, NR4 7UY
    United Kingdom

    Active - Recruiting

  • George Eliot Hospital

    Nuneaton, CV10 7DJ
    United Kingdom

    Active - Recruiting

  • North West Anglia NHS Foundation Trust

    Peterborough, PE3 9GZ
    United Kingdom

    Active - Recruiting

  • University Hospitals Dorset NHS Foundation Trust

    Poole, BH15 2JB
    United Kingdom

    Active - Recruiting

  • Betsi Cadwaldr University Health Board

    Rhyl, LL18 5UJ
    United Kingdom

    Active - Recruiting

  • Salisbury NHS Foundation Trust

    Salisbury, SP2 8BJ
    United Kingdom

    Active - Recruiting

  • Sheffield Teaching Hospitals NHS Foundation Trust

    Sheffield, S5 7AU
    United Kingdom

    Active - Recruiting

  • University Hospital of North Tees

    Stockton-on-Tees, TS19 8PE
    United Kingdom

    Active - Recruiting

  • South Tyneside & Sunderland NHS Foundation Trust

    Sunderland, SR4 7TP
    United Kingdom

    Active - Recruiting

  • Southend University Hospital

    Westcliff-on-Sea, SS0 0RY
    United Kingdom

    Active - Recruiting

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