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

Recruiting

• Conditions: Heart Failure With Preserved Ejection Fraction (HFpEF)

• Registration Number: NCT05383287
• Lead Sponsor: Manchester University NHS Foundation Trust

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-04-25
• Study First Submitted QC: 2022-05-16
• Study First Posted: 2022-05-20
• Study Start: 2022-08-12
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-30
• Last Update Posted: 2023-08-31
• Primary Completion: 2029-10
• Study Completion: 2029-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite of all cause mortality and hospitalisation for heart failure	7.5 years

Secondary Outcome Measures

Name	Time	Method
Hospitalisation for heart failure	7.5 years
All cause mortality	7.5 years
Identification of HFpEF phenotypes	7.5 years	Machine Learning analysis will be implemented to assess relationships between multiple clinical variables and the aforementioned outcome measures to identify novel HFpEF phenotypes.

Trial Locations

Locations (1)

Manchester University NHS Foundation trust; 🇬🇧 Manchester, United Kingdom