HAPPIFY_v1
Research type
Research Study
Full title
Heart fAilure with Preserved ejection fraction: Plethysmography for Interstitial Function and skin biopsY
IRAS ID
224508
Contact name
Giacomo Rossitto
Contact email
Sponsor organisation
NHS Greater Glasgow and Clyde
Duration of Study in the UK
0 years, 7 months, 31 days
Research summary
Heart failure with preserved ejection fraction (HFpEF) currently accounts for approximately half of cases of heart failure (HF), and no effective treatment has yet been found. This is due to a complex pathophysiology, in which both cardiac and “peripheral” mechanism, such as vascular stiffness and endothelial dysfunction, act as contributors.
Hypertension precedes HFpEF and is the most prevalent co-morbidity. Recent evidence showed that direct determinants of hypertension development can be primary changes in peripheral (skin) interstitium, such as hypertonic tissue salt accumulation and derangement in its regulators (glycosaminoglycans, lymphatic vessels, immune cells). A functional demonstration still lacks in humans.
We speculate that primary changes in the interstitial milieu might directly result in interstitial dysfunction which would secondarily affect also vascular and cardiac performance. This would mark the progression of hypertension to overt fluid tolerance impairment, i.e. HFpEF.
The physiological, cross-sectional HAPPIFY study aims at comparing microvascular permeability and filtration (as indexes of interstitial function) between HFpEF patients and age-matched controls, as assessed non-invasively by strain gauge plethysmography. Functional data will be correlated with ex-vivo analysis of interstitial composition and structure, from skin biopsies.
A further optional sub-study will extend these ex-vivo analyses to the impact of interstitium on the function of resistance arteries, dissected from a gluteal subcutaneous fat biopsy.
The study design includes an eligibility visit, unless assessed during a routine Clinic visit, and a single main study visit at the Queen Elizabeth University Hospital Clinical Research Facility (QEUH CRF). Participants will undergo strain gauge plethysmography for interstitial function, other non-invasive measurements of vascular function and a skin biopsy; those consenting also to the sub-study will undergo also a gluteal biopsy and will be invited for a wound check 7-10 days later.REC name
West of Scotland REC 3
REC reference
17/WS/0091
Date of REC Opinion
2 Jun 2017
REC opinion
Further Information Favourable Opinion