MICROFIT feasibility study
Research type
Research Study
Full title
MICROFIT (Microvascular coronary rehabilitation for improving treatment), a feasibility study
IRAS ID
340782
Contact name
Joanna Abramik
Contact email
Sponsor organisation
Royal United Hospitals Bath NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 2 months, 28 days
Research summary
Coronary heart disease is common in the UK, with most research focusing on coronary artery disease caused by atherosclerosis (resulting from build up of cholesterol and inflammation in heart arteries). However, some individuals experience angina symptoms without significant atherosclerosis due to coronary microvascular dysfunction (CMD), a condition involving the small vessels of the heart that are invisible to the naked eye. CMD can cause significant chest pain, breathlessness, and is linked to increased risk of cardiovascular complications or death. Despite advancements in diagnosing CMD, the condition remains under-recognized, and treatment options are limited.
MICROFIT is a 24-week, individualized diet and exercise rehabilitation programme specifically designed to address CMD. 40 patients will be randomly allocated into Usual Care or Usual Care + MICROFIT programme. Developed by a team of cardiologists, physiologists, dieticians, and personal trainers, the programme includes one-on-one high-intensity interval training (HIIT) sessions at local fitness facilities, with additional prescribed home exercises. HIIT has been proven safe and effective in patients with heart disease. Patients will also receive regular support from a dietician to adopt a Mediterranean-based diet, which has been scientifically proven to benefit CMD patients. A cardiologist ensures the patients are prescribed optimal medical therapies for their symptoms and related conditions, such as hypertension or high cholesterol.
The goal of MICROFIT is to help patients sustain long-term healthy lifestyle changes. Expected outcomes include improvements in weight, blood pressure, diabetes control, fitness levels, and blood flow to the heart. These changes are anticipated to reduce chest pain symptoms and lessen the need for medication.
This feasibility trial will be a first stepping stone to design of a multicentre RCT which will assess the efficacy of MICROFIT in reducing anginal burden in CMD patients. We believe MICROFIT will offer a valuable new, sustainable treatment option for this important, but often overlooked patient population.REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
24/SW/0125
Date of REC Opinion
22 Oct 2024
REC opinion
Favourable Opinion