A Health Coach-Led Digital Lifestyle Intervention (HEALDI) for the Regression of Diffuse Myocardial Fibrosis: A Randomised Controlled Trial
Sponsor: National University of Singapore
Trial Details
| Condition | Myocardial Fibrosis, Left Ventricle Hypertrophy, Hypertensive Disease, Hypertension |
| Intervention | HEALDI Intervention |
| Phase | NA |
| Status | Not_yet_recruiting |
| Participants | 200 |
| Est. Completion | 1 June 2028 |
| Last Updated | 15 Apr 2026 |
Primary Outcome
Regression of diffuse myocardial fibrosis
Eligibility Criteria
Inclusion Criteria
Inclusion Criteria: * Left ventricular hypertrophy on cardiovascular magnetic resonance based on local age and sex specific criteria * Age 40-70 years old * Has internet access * Owns and uses a smartphone daily * Able to converse and comprehend the English or Chinese language Exclusion Criteria: * History of major cardiovascular events (MACE), which is defined as coronary heart disease death, non-fatal myocardial infarction, stroke * Diagnosed with secondary causes of hypertension (E.g., renal causes - renal artery stenosis, chronic renal failure; endocrine causes- pheochromocytoma, Cushing's syndrome, hyperthyroidism; cardiac causes - coarctation of the aorta) * Diagnosed with significant coronary artery disease with previous percutaneous intervention or coronary artery bypass surgeries * Diagnosed with cardiac arrhythmias such as atrial fibrillation and frequent premature ventricular contractions * Diagnosed with inherited/acquired cardiomyopathies (E.g., hypertrophic cardiomyopathy, dilated cardiomyopathy) * Diagnosed with infiltrative disease (E.g., cardiac amyloid, cardiac sarcoid) * Contraindications to Brain and Cardiac Magnetic Resonance or gadolinium contrast (E.g., renal failure- eGFR \<30ml/min/m2 or documented contrast allergy; implantable devices such as cardiac pacemakers, brain aneurysms or clips, metal implants (including braces), foreign bodies in the eye; claustrophobia; end organ failure; women who are pregnant or breast-feeding) * Any pre-existing medical conditions or disabilities that limits their participation in lifestyle interventions (E.g., Dementia) * Individuals who have achieved the Singapore physical activity guideline of 150 minutes of moderate intensity exercise or 75 minutes of vigorous intensity exercise per week or an equivalent combination per week * Limited life expectancy of less than 12 months * Participating in other research projects involving behavioural therapy or changes related to physical activity
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