A Health Coach-Led Digital Lifestyle Intervention (HEALDI) for the Regression of Diffuse Myocardial Fibrosis: A Randomised Controlled Trial
Trial ID: NCT07530562
Status: NOT_YET_RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2026-04
Completion date: 2028-06
Sponsor: National University of Singapore
Collaborators: National Heart Centre Singapore
Conditions: Myocardial Fibrosis; Left Ventricle Hypertrophy; Hypertensive Disease; Hypertension
Interventions: HEALDI Intervention
Enrollment: 200
Age range: 40 Years - 70 Years
Sex: ALL

Summary:
Aim: To evaluate the effectiveness of an artificial intelligence (AI)-assisted 12-month Health Coach-Led Digital Lifestyle Intervention (HEALDI) versus control on diffuse myocardial fibrosis and ambulatory blood pressure in individuals with hypertensive heart disease (HHD), with secondary outcomes including multi-organ health parameters, health behaviours, social support, psychological health, and health-related quality of life.

Background: The global prevalence of hypertensive heart disease (HHD) has increased approximately 1.5-fold, from 7.82 million cases in 1990 to 12.50 million in 2021, and it is now the second leading cause of heart failure worldwide. In HHD, chronic pressure overload drives fibroblast activation and interstitial collagen deposition, leading to diffuse myocardial fibrosis which is associated with cardiac dysfunction, arrhythmias, impaired coronary flow reserve, and an increased risk of sudden cardiac death and heart failure. Although diffuse myocardial fibrosis is potentially reversible, no approved anti-fibrotic pharmacological therapy currently exists. Furthermore, there is limited evidence evaluating the effectiveness of lifestyle interventions, particularly aerobic exercise, in reversing diffuse myocardial fibrosis.

Design: A parallel, single-blinded two-arm randomised controlled trial.

Method: This study is a randomised controlled trial with repeated measures, recruiting 200 physically inactive individuals with HHD from the community, including participants from Project RESET, a community-based cohort study in Singapore. Participants will be randomly allocated to either the intervention or control group.

Participants in the intervention group will receive the 12-month HEALDI intervention, which includes the HEALDI mobile application, wearable device, and remote health coaching. Participants in the control group will receive a wearable device and a basic mobile application without intervention features, used solely for data collection.

Data will be collected at baseline (upon randomisation) and at 6, 12 and 24 months. A process evaluation will be conducted using intervention engagement data. In addition, semi-structured interviews with participants and health coaches will explore perceptions of the intervention and behaviour change. A within-trial economic evaluation, from both healthcare system and societal perspectives, will be performed to assess cost-effectiveness.

Significance: This study will generate insights into the role of lifestyle modification as a complementary, non-pharmacological strategy alongside pharmacotherapy to halt or slow HHD progression, improving long-term cardiovascular outcomes.

Eligibility 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

Outcomes:
Regression of diffuse myocardial fibrosis