Microvascular Coronary Rehabilitation For Improving Treatment - Feasibility Study

Recruiting now · Not applicable

Conditions studied: Microvascular Coronary Dysfunction, Microvascular Angina, Coronary Microvascular Dysfunction (CMD)

In brief

The goal of this clinical trial is to assess the feasibility of undertaking a randomized controlled trial assessing the impact of a personalised, intense cardiac rehabilitation programme involving high intensity interval exercise (HIIT) and dietary advice (termed MICROFIT) on symptom burden in patients with microvascular coronary dysfunction. The main questions it aims to answer are: 1. Feasibility of undertaking randomised controlled trial of MICROFIT in patients with coronary microvascular dysfunction (recruitment rates, retention and adherence, acceptability of MICROFIT and participants' and practitioners' experiences of trial participation) 2. Preliminary data on the effect that MICROFIT has on angina symptoms in patients with microvascular coronary dysfunction, as measured by Seattle Angina Questionnaire 3. Preliminary data on the fidelity and clinical efficacy of MICROFIT Participants will be randomized to either MICROFIT + Usual Care, or Usual Care group. Participants in both arms of the trial will: * Undergo a series of investigations, including cardiopulmonary exercise test (CPET), dual xray absorptiometry (DEXA), echocardiogram, cardiac MRI scan, blood tests, at the start of the trial and again after 6 months * Measure their living activity by using an activity tracker (GeneActiv) as well as a photographic diet diary for a week at the start of the trial and again after 6 months * Complete a series of questionnaires to assess angina symptom burden, mental health and quality of life, at the start of the trial and again after 6 months. Participants in the intervention arm of the study will: 1. Undergo MICROFIT intervention. MICROFIT includes a combination of exercise and diet management sessions over 24 weeks. It involves: * 1:1 high-intensity interval training ('HIIT') sessions with a personal trainer and guidance on exercise sessions to be performed at home * 1:1 sessions with a dietician to support them with improvements in diet. 2. Visit clinic on two additional occassions during the trial to discuss their progress with a cardiologist 3. Undergo an interview at the end of the study to discuss their experiences of participation in the study 4. Receive a debrief on their investigation results and progress made at the end of their study Participants in the Usual Care arm of the study will: 1. Receive standard Usual Care advice regarding lifestyle changes and targeted medical therapy offered to patients with coronary microvascular dysfunction. 2. Receive a debrief on their investigation results and progress made at the end of their study 3. Undergo a 'taster' session with the personal trainer to discover what the intervention involves.

Key facts

Study ID: NCT06681896
Run by: Royal United Hospitals Bath NHS Foundation Trust
People needed: 40
Starts: 2024-11-12
Expected to finish: 2027-01-01
Last updated by the study team: 2025-06-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age ≥18
Angina or angina equivalent symptoms
Unobstructed coronary arteries at the time of coronary angiogram. This will be defined as plaque causing <40% epicardial vessel stenosis or 40-90% with a fractional flow reserve (FFR) ≥0.8
Evidence of microvascular dysfunction on ICA (CFR <2.5 and/or AchFR <1.5)

You may not qualify if…

New York Heart Association class III/IV heart failure
Severe left ventricular impairment (ejection fraction≤35%)
Severe heart valve disease
Significant cardiomyopathy (as assessed by a cardiologist)
Severe hypertension (defined as blood pressure >180/120mmHg (despite three anti-hypertensive agents)
Uncontrolled arrhythmia
A history of aortic dissection, recent (<6 months) acute pulmonary embolus, deep vein thrombosis, stroke or transient ischaemic attack, severe autonomic or peripheral neuropathy, acute systemic illness or fever, severe acute or chronic renal failure, severe pulmonary fibrosis or interstitial lung disease (in line with other trials investigating HIIT exercise)
Pregnancy or breastfeeding (at any point during the study. Patients becoming pregnant during the study will be asked to withdraw due to additional radiation exposure and risks from HIIT)
Physical inability to participate in exercise
Significant claustrophobia or metallic implants which would limit MRI imaging
Intolerance to regadenoson testing (high degree atrioventricular block, severe asthma or airways disease)
Current participation in another intervention-based trial
Inability to fully understand the verbal and written descriptions of the study and instructions provided during the study duration.

Where it is running

Royal United Hospitals Bath NHS Foundation Trust — Bath, United Kingdom (enrolling)
University Hospitals Bristol and Weston NHS Foundation Trust — Bristol, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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