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

Heart Failure With Preserved Ejection Fraction (HFpEF) Clinical Trial

— TRAITS-HFpEF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05383287
• Other study ID #: 2016CD012
• Status: Recruiting
• Start date: August 12, 2022
• Est. completion date: October 2029

Study information

• Verified date: August 2023
• Source: Manchester University NHS Foundation Trust
• Contact: Fardad Soltani, MBChB, MRCP
• Phone: 0161 291 3223
• Email: fardad.soltani[@]mft.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1250
• Est. completion date: October 2029
• Est. primary completion date: October 2029
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United Kingdom	Manchester University NHS Foundation trust	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Manchester University NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

Butler J, Fonarow GC, Zile MR, Lam CS, Roessig L, Schelbert EB, Shah SJ, Ahmed A, Bonow RO, Cleland JG, Cody RJ, Chioncel O, Collins SP, Dunnmon P, Filippatos G, Lefkowitz MP, Marti CN, McMurray JJ, Misselwitz F, Nodari S, O'Connor C, Pfeffer MA, Pieske B, Pitt B, Rosano G, Sabbah HN, Senni M, Solomon SD, Stockbridge N, Teerlink JR, Georgiopoulou VV, Gheorghiade M. Developing therapies for heart failure with preserved ejection fraction: current state and future directions. JACC Heart Fail. 2014 Apr;2(2):97-112. doi: 10.1016/j.jchf.2013.10.006. — View Citation

Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JG, Coats AJ, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GM, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; Authors/Task Force Members; Document Reviewers. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2016 Aug;18(8):891-975. doi: 10.1002/ejhf.592. Epub 2016 May 20. No abstract available. — View Citation

Shah SJ, Kitzman DW, Borlaug BA, van Heerebeek L, Zile MR, Kass DA, Paulus WJ. Phenotype-Specific Treatment of Heart Failure With Preserved Ejection Fraction: A Multiorgan Roadmap. Circulation. 2016 Jul 5;134(1):73-90. doi: 10.1161/CIRCULATIONAHA.116.021884. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of all cause mortality and hospitalisation for heart failure		7.5 years
Secondary	All cause mortality		7.5 years
Secondary	Hospitalisation for heart failure		7.5 years
Secondary	Identification of HFpEF phenotypes	Machine Learning analysis will be implemented to assess relationships between multiple clinical variables and the aforementioned outcome measures to identify novel HFpEF phenotypes.	7.5 years