Characteristics, Phenotypes, and TRAITS of Heart Failure With Preserved Ejection Fraction (TRAITS-HFpEF)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
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 Design
Outcome Measures
Primary Outcome Measures
- Composite of all cause mortality and hospitalisation for heart failure [7.5 years]
Secondary Outcome Measures
- All cause mortality [7.5 years]
- Hospitalisation for heart failure [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.
Eligibility Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Manchester University NHS Foundation Trust
Investigators
- Principal Investigator: Chris Miller, MBChB, MRCP, Manchester University NHS FT
Study Documents (Full-Text)
None provided.More Information
Publications
- 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. Review.
- Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JG, Coats AJ, Falk V, González-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.
- 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. Review.
- 2016CD012