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Characteristics, Phenotypes, and TRAITS of Heart Failure With Preserved Ejection Fraction (TRAITS-HFpEF)

Sponsor: Manchester University NHS Foundation Trust

NCT ID: NCT05383287

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 86 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
1,250
Started
2022-08-12
Last checked
2025-09

Plain English Summary

What is this study?

  • • Testing a new treatment for heart failure with preserved ejection fraction (hfpef)
  • • Clinical study - 1,250 participants
  • • Heart failure with preserved ejection fraction (HFpEF), a certain type of heart failure, occurs when the heart doesn't 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?

  • • Manchester - Manchester University NHS Foundation trust

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

About This Trial

Heart failure with preserved ejection fraction (HFpEF), a certain type of heart failure, occurs when the heart doesn't pump blood around the body properly. It can cause breathlessness, tiredness, and swollen feet or ankles. It is not clear why people develop HFpEF and treatment options are very limited. TRAITS-HFpEF is a study that aims to understand why people develop HFpEF, identify new tests and treatments, and gain information on the life expectancy of people living with this condition. It will do this by routinely collecting information on people attending a specialised outpatient HFpEF clinic.

More detail

HFpEF represents the single largest unmet need in cardiovascular medicine (Butler et al, 2014). The proportion of patients with HFpEF ranges from 22 to 73% of all heart failure patients across all clinical settings, including primary care, hospital care and hospital admission (Ponikowski et al, 2016). Treatment options in HFpEF are very limited, and several clinical trials have demonstrated neutral results when assessing survival benefit from medical therapy. A common theme for this is the heterogeneity that exists in the HFpEF patient population and non-targeted therapy is inadequate for this diverse population. Patients need to be characterised according to their clinical phenotypes and underlying biological mechanisms in order to provide targeted patient-specific treatment. (Shah et al, 2016) TRAITS-HFpEF is an observational cohort study that aims to assess the epidemiology, and the association of clinical variables and outcomes of patients with HFpEF. A dedicated specialist HFpEF clinic provides the opportunity to recruit and collect data on a large cohort of patients that can provide insights into different HFpEF phenotypes and their associations and outcomes. This can help direct future research and delivery of specialist care. All patients attending the HFpEF clinic at Manchester University NHS Foundation Trust (MFT) will be approached. The expectation is to recruit approximately 1,250 patients over a 5-year period. With the patients consent, a blood sample of approximately 10mL will be taken for biobanking to allow measurement of yet to be identified biomarkers, including plasma and DNA. This will be optional for patients. All clinical variables will be documented at the time of the recruitment.

Heart Failure With Preserved Ejection Fraction (HFpEF)

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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

  • ✓Patients attending the HFpEF clinic at MFT.

Who cannot take part

  • ✗Age \< 18 years
  • ✗Imprisonment
  • ✗Inability to provide full written or verbal agreement to take part in English
See the full criteria
Inclusion Criteria: * Patients attending the HFpEF clinic at MFT. Exclusion Criteria: * Age \< 18 years * Imprisonment * Inability to provide full written or verbal informed consent in English

Where Is This Study? (1 UK site)

Manchester University NHS Foundation trust

Manchester M13 9WU, 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
Data sourced from ClinicalTrials.gov · Last verified: 2025-09