FLOW mediated vasodialatation and endothelial function response to heart failure REHABilitation (FlowRehab study)
Implementing Organization
Manipal Academy of Higher Education
Principal Investigator
Dr. Abraham Samuel Babu
Manipal Academy Of Higher Education, Manipal, Karnataka
abrahambabu@gmail.com
CO-Principal Investigator
Dr. Prakashini K
Manipal Academy Of Higher Education
Manipal,Madhav Nagar, Manipal,Karnataka,Udupi-576104
Dr. Padma Kumar R
Manipal Academy Of Higher Education, Manipal,Madhav Nagar, Manipal,Karnataka,Udupi-576104
Dr. Sanjay Bharati
Manipal Academy Of Higher Education,Tiger Circle Road, Madhav Nagar, Manipal,Karnataka,Udupi-576104
About
Decompensation requiring re-admission is a major concern for patients with heart failure (HF). Each episode of decompensation has been shown to worsen endothelial function and thereby initiate a cascade of events that eventually results in end stage heart disease. The need to minimise re-admissions is therefore vital to the continuum of HF care. With progression in worsening function, breaking the cycle is important and could be mediated through exercise and cardiac rehabilitation (CR). With increasing costs on therapies for patients with HF, it is important to establish effectiveness of rehabilitation pathways to better promote and facilitate continuum of care. We hypothesise that worsening HF would worsen endothelial function (both peripherally and at the cellular level) thereby impacting function. Exercise improves endothelial function and therefore could have reverse effect on endothelial function resulting in a change in outcomes in those with decompensated HF. Therefore, a prospective randomized controlled trial will be carried out on 52 patients who have been stabilised following decompensation for HF. They will be randomized to either the CR pathway or standard care. The primary outcome to be assessed will be peripheral endothelial function, assessed by flow mediated vasodilatation from ultrasound. Secondary outcomes will include biochemical markers of endothelial function (endothelin-1 and vascular endothelial growth factor), galectin-3, peripheral muscle function (lactate build up), ventricular strain, exercise capacity and quality of life. Additionally, the number of re-admission and mortality will be assessed. All these outcomes will be assessed at enrolment, discharge, 3 months, 6 months and 12 months following randomization. All outcomes will be subject to robust statistical analysis and will be analysed as per initial group allocation.
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