Heart failure with preserved ejection fraction (HFpEF) pathophysiology study (IDENTIFY-HF): does increased arterial stiffness associate with HFpEF, in addition to ageing and vascular effects of comorbidities? Rationale and design

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Author
Ali, Danish
Callan, Nualla
Ennis, Stuart
Powell, Richard
McGuire, Scott
McGregor, Gordon
Weickert, Martin
Miller, Michelle A.
Cappuccio, Francesco P.
Banerjee, Prithwish
Date
2019-11-19Acceptance date
2019-09-24
Type
Article
Publisher
BMJ Publishing Group
ISSN
2044-6055
Metadata
Show full item recordAbstract
Aims: There has been a paradigm shift proposing that comorbidities are a major contributor towards the heart failure with preserved ejection fraction (HFpEF) syndrome. Furthermore, HFpEF patients have abnormal macrovascular and microvascular function, which may significantly contribute towards altered ventricular-vascular coupling in these patients. The IDENTIFY-HF study will investigate whether gradually increased arterial stiffness (in addition to ageing) as a result of increasing common comorbidities, such as hypertension and diabetes, is associated with HFpEF.
Methods and analysis: In our observational study, arterial compliance and microvascular function will be assessed in five groups (Groups A to E) of age, sex and body mass index matched subjects (age ≥70 years in all groups):
Group A; normal healthy volunteers without major comorbidities such as hypertension and diabetes mellitus (control). Group B; patients with hypertension without diabetes mellitus or heart failure (HF). Group C; patients with hypertension and diabetes mellitus without HF. Group D; patients with HFpEF. Group E; patients with heart failure and reduced ejection fraction (parallel group). Vascular function and arterial compliance will be assessed using pulse wave velocity, as the primary outcome measure. Further outcome measures include cutaneous laser Doppler flowmetry as a measure of endothelial function, transthoracic echocardiography and exercise tolerance measures. Biomarkers include NT-proBNP, high-sensitivity troponin T, as well as serum galectin-3 as a marker of fibrosis.
Ethics and dissemination: The study was approved by the regional research ethics committee (REC), West Midland and Black Country 17/WM/0039, UK, and permission to conduct the study in the hospital was also obtained from the RDI, UHCW NHS Trust. The results will be published in peer-reviewed journals and presented in local, national and international medical society meetings.
Trial registration number: NCT03186833
Journal/conference proceeding
BMJ Open;
Citation
Ali, D., Callan, N., Ennis, S., Powell, R., McGuire, S., McGregor, G., Weickert, M.O., Miller, M.A., Cappuccio, F.P. and Banerjee, P. (2019) 'Heart failure with preserved ejection fraction (HFpEF) pathophysiology study (IDENTIFY-HF): does increased arterial stiffness associate with HFpEF, in addition to ageing and vascular effects of comorbidities? Rationale and design', BMJ Open, 9(11). DOI: 10.1136/bmjopen-2018-027984.
Description
Article published in BMJ Open on 19 November 2019, available open access at: http://dx.doi.org/10.1136/bmjopen-2018-027984.
Sponsorship
Cardiff Metropolitan University (Grant ID: Cardiff Metropolian (Internal))
Research grant from the West Midlands Clinical Research Network, National Institute of Health Research, UK. The study is sponsored by the Research, Development & Innovation department of the University Hospitals Coventry & Warwickshire NHS Trust (RDI, UHCW), UK.
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