Personalized exercise and dietary program for patients with microvascular coronary dysfunction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the feasibility of a personalized, intense cardiac rehabilitation program called MICROFIT, which combines high intensity interval exercise training and dietary advice, for patients suffering from microvascular coronary dysfunction. The study will evaluate recruitment rates, retention, adherence, and the acceptability of the intervention among participants and practitioners. Additionally, it will gather preliminary data on the impact of MICROFIT on angina symptoms, measured by the Seattle Angina Questionnaire, and assess the fidelity and clinical efficacy of the program. Participants will be randomized into either the MICROFIT group or a usual care group.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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's running

• Royal United Hospitals Bath NHS Foundation Trust
  Bath, United Kingdom Recruiting
• University Hospitals Bristol and Weston NHS Foundation Trust
  Bristol, United Kingdom Recruiting

Study contacts

• Principal investigator: Ali Khavandi — Royal United Hospitals Bath NHS Foundation Trust
• Study coordinator: Joanna Abramik
• Email: joanna.abramik1@nhs.net
• Phone: +44 1225 82109

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.