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UK Heart Failure With Preserved Ejection Fraction

Sponsor: Manchester University NHS Foundation Trust

NCT ID: NCT05441839

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Not specified by the sponsor
How long the study runs
Study runs about 176 months (dates as stated)
About the drug or intervention
Not specified by the sponsor
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
18 Years and over
Who
All
Number of participants
10,000
Started
2022-10-07
Last checked
2025-05

Plain English Summary

What is this study?

  • • Testing a new treatment for heart failure with preserved ejection fraction (hfpef)
  • • Clinical study - 10,000 participants
  • • Heart failure occurs when the heart is no longer able to pump blood around the body properly

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with heart failure with preserved ejection fraction (hfpef)

Where?

  • • Abercynon - Cwm Taf Morgannwg University Health Board
  • • Aylesbury - Buckinghamshire Healthcare NHS Trust
  • • Birmingham - University Hospitals Birmingham NHS Foundation Trust
  • • Chelmsford - Broomfield Hospital
  • • +22 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Heart Failure With Preserved Ejection Fraction (HFpEF)

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Written agreement to take part
  • ✓Diagnosis of HFpEF by a cardiologist with HF expertise, or a primary care physician with HF expertise, or a heart...
  • ✓Natriuretic peptide levels measured

Who cannot take part

  • ✗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 heart tamponade
  • ✗Known genetic hypertrophic cardiomyopathy or obstructive hypertrophic cardiomyopathy
  • ✗Known arrhythmogenic right ventricular cardiomyopathy
See the full criteria
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

Where Is This Study? (26 UK sites)

Cwm Taf Morgannwg University Health Board

Abercynon CF31 1RQ, United Kingdom

Recruiting
Site contact (verified)

Buckinghamshire Healthcare NHS Trust

Aylesbury HP21 8AL, United Kingdom

Recruiting
Site contact (verified)

University Hospitals Birmingham NHS Foundation Trust

Birmingham B15 2GW, United Kingdom

Recruiting
Site contact (verified)

Broomfield Hospital

Chelmsford CM1 7ET, United Kingdom

Recruiting
Site contact (verified)

NHS Tayside

Dundee DD2 1UB, United Kingdom

Recruiting
Site contact (verified)

Glasgow Royal Infirmary

Glasgow G4 0SF, United Kingdom

Recruiting
Site contact (verified)

West Suffolk NHS Foundation Trust

Ipswich IP33 2QZ, United Kingdom

Recruiting
Site contact (verified)

Kettering General Hospital

Kettering NN16 8UZ, United Kingdom

Recruiting
Site contact (verified)

Leeds Teaching Hospitals NHS Trust

Leeds LS1 3EX, United Kingdom

Recruiting
Site contact (verified)

University Hospitals of Leicester NHS Foundation Trust

Leicester LE5 4PW, United Kingdom

Recruiting
Site contact (verified)

Barnet Hospital

London EN5 3DJ, United Kingdom

Recruiting
Site contact (verified)

Guys and St. Thomas' NHS Foundation Trust

London SE1 7EH, United Kingdom

Recruiting
Site contact (verified)

Imperial College Healthcare NHS Trust

London W2 1NY, United Kingdom

Recruiting
Site contact (verified)

Manchester University NHS Foundation trust

Manchester M13 9WU, United Kingdom

Recruiting
Site contact (verified)
Fardad Soltani 0161 291 32230161 291 3223fardad.soltani@mft.nhs.uk

The James Cook University Hospital

Middlesbrough TS4 3BW, United Kingdom

Recruiting
Site contact (verified)

Northumbria Healthcare NHS Foundation Trust

Newcastle upon Tyne NE23 6NZ, United Kingdom

Recruiting

Norfolk & Norwich University Hospitals NHS Foundation Trust

Norwich NR4 7UY, United Kingdom

Recruiting
Site contact (verified)

George Eliot Hospital

Nuneaton CV10 7DJ, United Kingdom

Recruiting
Site contact (verified)

North West Anglia NHS Foundation Trust

Peterborough PE3 9GZ, United Kingdom

Recruiting
Site contact (verified)

University Hospitals Dorset NHS Foundation Trust

Poole BH15 2JB, United Kingdom

Recruiting
Site contact (verified)

Betsi Cadwaldr University Health Board

Rhyl LL18 5UJ, United Kingdom

Recruiting
Site contact (verified)

Salisbury NHS Foundation Trust

Salisbury SP2 8BJ, United Kingdom

Recruiting
Site contact (verified)

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield S5 7AU, United Kingdom

Recruiting
Site contact (verified)

University Hospital of North Tees

Stockton-on-Tees TS19 8PE, United Kingdom

Recruiting
Site contact (verified)

South Tyneside & Sunderland NHS Foundation Trust

Sunderland SR4 7TP, United Kingdom

Recruiting
Site contact (verified)

Southend University Hospital

Westcliff-on-Sea SS0 0RY, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Fardad Soltani, MBChB MRCP

Sponsor contact

CONTACT

0161 291 3223 fardad.soltani@mft.nhs.uk

Lucy Priestner

Sponsor contact

CONTACT

0044 161 291 3244 lucy.priestner@mft.nhs.uk
Data sourced from ClinicalTrials.gov · Last verified: 2025-05