Myocardial FibrosisNCT07530562
A Health Coach-Led Digital Lifestyle Intervention (HEALDI)
A study testing HEALDI Intervention in people with Myocardial Fibrosis and Left Ventricle Hypertrophy, run by National University of Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Myocardial Fibrosis, Left Ventricle Hypertrophy, Hypertensive Disease
- What is being tested?
- HEALDI Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Health Coach-Led Digital Lifestyle Intervention (HEALDI) for the Regression of Diffuse Myocardial Fibrosis: A Randomised Controlled Trial
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.
Read more
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.
Read the detailed description
Specific Study Aims
- To compare the effectiveness of HEALDI on change in diffuse myocardial fibrosis, ambulatory blood pressure, with secondary outcomes including multi-organ clinical parameters (e.g. blood tests, liver and brain imaging) and patient-reported outcomes (e.g. physical activity, dietary practices, perceived stress, sleep quality, medication adherence, social support, psychological health, and health-related quality of life).
- Examine the cost-effectiveness of HEALDI intervention.
- Explore the perceptions of the individuals with HHD and health coaches regarding HEALDI.
Hypotheses
It is hypothesised that participants who received the HEALDI intervention, compared to the control group will have:
- Greater regression in diffuse myocardial fibrosis;
- Greater improvement in ambulatory blood pressure;
- Improved multi-organ clinical paramaters;
- Greater adoption and sustained adherence to health behaviours;
- Better quality of life;
- Lower cost to participants and hospitals.
HEALDI Intervention The HEALDI intervention is a 12-month, AI-assisted, health coach-led digital lifestyle intervention comprising a wearable device, HEALDI mobile application, health coach web portal, and administrative web portal. The system functions as an integrated platform to facilitate interaction between participants and health coaches, supporting personalised lifestyle modification.
Participants will access the HEALDI mobile application via their personal smartphones and will be provided with a wearable device that continuously collects activity and physiological data. These data, together with participant-entered health metrics (e.g., blood pressure, medication), will be synchronised to a secure cloud server and made available on the health coach portal to inform coaching sessions, including goal setting and progress review.
Certified health coaches will deliver 30-45-minute remote coaching sessions over 12 months: weekly during the first month, biweekly for the subsequent 5 months, and monthly for the remaining 6 months.
Data Analysis Data will be analysed using IBM SPSS Statistics Version 29.0, with two-tailed p<0.05 indicating statistical significance. Analyses will follow the intention-to-treat principle. Baseline categorical variables will be compared using Chi-squared or Fisher's exact tests, and continuous variables using independent t-tests or Mann-Whitney U tests, depending on normality. Linear mixed models will assess repeated continuous outcomes, and generalized estimating equations (GEE) will be used for ordinal outcomes. Descriptive analyses will summarise utilisation of the mobile app, wearable adherence, and coaching engagement.
Qualitative interviews will be audio-recorded, transcribed, and analysed thematically using Braun and Clarke's six-step framework. Two independent coders will familiarise themselves with the data, generate initial codes and iteratively refine them through discussion.
- Being tested
- HEALDI Intervention
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEALDI InterventionOther
Proposed Mobile application features include: educational content on HHD and lifestyle behaviours (e.g., physical activity, nutrition, stress, sleep), AI-driven exercise recommendations (frequency, intensity, duration, and type), reviewed and approved by health coaches prior to delivery, Health logging (e.g., blood pressure, medication), Personalised dashboard displaying wearable and self-reported data, Goal setting and progress tracking (short- and long-term), Behavioural nudges (AI-driven and rule-based), Messaging function to facilitate communication with health coaches. Health coaching session involve personalised goal setting and review.
| Study group | Role | What they receive |
|---|---|---|
| HEALDI Intervention Group | Experimental | A 12-month, AI-assisted, health coach-led digital lifestyle intervention where participants will receive a wearable, HEALDI mobile app and remote health coaching sessions. Receives: Other: HEALDI Intervention |
| Control Group | No intervention | Participants will receive a wearable and basic mobile app without intervention features, used solely for data collection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regression of diffuse myocardial fibrosis
Change in indexed interstitial volume assessed by cardiovascular magnetic resonance
Measured: Baseline and 12 months upon randomisation
Secondary outcomes (39)
Blood pressure
Change in the average 24-hour systolic and diastolic blood pressure
Measured: Baseline and 12 months upon randomisation
Left ventricular function
Assessed using cardiovascular magnetic resonance
Measured: Baseline and 12 months upon randomisation.
Left ventricular mass
Assessed using cardiovascular magnetic resonance for changes from baseline, indexed to body surface area (g/m2).
Measured: Baseline and 12 months upon randomisation.
Left ventricular volume
Assessed using cardiovascular magnetic resonance.
Measured: Baseline and 12 months upon randomisation.
Diastolic and systolic function
Assessed by echocardiogram
Measured: Baseline and 12 months (upon randomisation)
Valvular function
Assessed by echocardiogram
Measured: Baseline and 12 months (upon randomisation).
Heart function
Assessed by electrocardiogram
Measured: Baseline and 12 months upon randomisation
First occurrence of cardiovascular event
Heart failure, Myocardial Infarction, Strokes and Death
Measured: 2 years
Markers of liver fat, inflammation and stiffness
Assessed by liver fibroscan
Measured: Baseline, 12 months and 24 months upon randomisation
Markers of liver fat, inflammation and stiffness
Assessed by liver magnetic resonance
Measured: Baseline and 12 months upon randomisation.
Brain structure
Assessed using brain magnetic resonance to characterise brain microstructure and extracellular space.
Measured: Baseline, 12 months and 24 months upon randomisation.
Cognitive function
Cognitive function will be assessed by the Montreal Cognitive Assessment (MoCA), on a 0-30 scoring scale.
Thresholds are:
Severe cognitive impairment: 0-9 Moderate cognitive impairment: 10-17 Mild cognitive impairment: 18-25 Normal cognitive performance: 26-30
Measured: Baseline and 12 months upon randomisation.
Cardiac and inflammatory markers
Cardiac and inflammatory markers, including but not limited to C-reactive Protein and Cardiac Troponins, will be assessed by blood specimen.
Measured: Baseline, 12 months and 24 months
Circulating biomarkers of inflammation and fibrosis
Assessed using blood specimen, inclusive of but not limited to, PICP (procollagen type I carboxy-terminal propeptide) and PIINP ( procollagen type III amino-terminal propeptide).
Measured: Baseline and 12 months upon randomisation.
Liver function tests
Assessed by blood specimen
Measured: Baseline, 12 months and 24 months from randomisation
Lipid profile
Assessed by blood specimen
Measured: Baseline, 12 months and 24 months upon randomisation
Renal function markers
Renal function markers, including but not limited to creatinine, will be assessed by blood specimen
Measured: Baseline, 12 months and 24 months from randomisation
Glycemic control
Assessed by fasting blood specimen
Measured: Baseline, 12 months and 24 months upon randomisation.
Body Mass Index
Change in Body Mass Index (BMI) will be assessed using weight (kilograms) and height (meters) combined to report BMI in kg/m^2.
Measured: Baseline, 12 months and 24 months upon randomisation.
Body composition: Body fat
Body fat (% or kg) will be assessed by Bioelectrical Impedance Analysis (BIA) and dual-energy X-ray absorptiometry (DEXA)
Measured: Baseline and 12 months upon randomisation.
Body composition: Muscle Mass
Muscle mass (kg) will be assessed by Bioelectrical Impedance Analysis (BIA) and dual-energy X-ray absorptiometry (DEXA).
Measured: Baseline and 12 months upon randomisation.
Body composition: Total body water
Total body water (% or Litre) will be assessed by Bioelectrical Impedance Analysis (BIA) and dual-energy X-ray absorptiometry (DEXA).
Measured: Baseline and 12 months upon randomisation.
Waist Circumference
Change in waist circumference
Measured: Baseline, 12 months and 24 months upon randomisation.
Energy expenditure
Assessed by whole body calorimetry
Measured: Baseline and 12 months upon randomisation.
Depressive symptoms
Change in depressive symptoms will be assessed by the Patient Health Questionnaire-9 (PHQ-9), on a scale of 0-27.
The following PHQ-9 ranges will be used:
Minimal: 0 - 4 Mild: 5 - 9 Moderate: 10 - 14 Moderately severe: 15 - 19 Severe: 20 - 27
Measured: Baseline, 6 months, 12 months and 24 months upon enrolment.
Anxiety symptoms
Change in anxiety symptoms will be assessed by the Generalized Anxiety Disorder-7 (GAD-7), on a scale of 0-21.
The following ranges will be used:
None/minimal: 0 - 4 Mild: 5 - 9 Moderate: 10 - 14 Severe: 15 - 21
Measured: Baseline, 6 months, 12 months and 24 months upon enrolment.
Health Behaviour: Physical Activity (Wearable)
Change in physical activity-related wearable data such as accelerometery.
Measured: Baseline, 6 months, 12 months and 24 months upon randomisation.
Health Behaviour: Physical Activity (IPAQ-SF)
Change in physical activity behaviour will be assessed by the International Physical Activity Questionnaire-Short Form (IPAQ-SF) to serve as a recall estimate of time spent performing physical activity (moderate or vigorous) and inactivity (sitting).
The 7-items include:
- Vigorous activity (days)
- Vigorous activity (minutes per day)
- Moderate activity (days)
- Moderate activity (minutes per day)
- Walking (days)
- Walking (minutes per day)
- Sitting (days)
Measured: Baseline, 6 months, 12 months and 24 months upon randomisation.
Health Behaviour: Physical Activity (MPAM-R)
Change in physical activity behaviour will be assessed by the Motives for Physical Activities Measure-Revised (MPAM-R), consisting of 30-items, each on a 7-point Likert scale (1 = Not at all true for me; 7 = Very true for me), for a total score ranging between 30 - 210. A higher score will indicate higher motivation, while a lower score will indicate lower motivation.
Measured: Baseline, 6 months, 12 months and 24 months upon randomisation.
Health Behaviour: Physical Activity (Stage of Change for Physical Activity Questionnaire)
Change in physical activity behaviour will be assessed by the Stage of Change for Physical Activity Questionnaire. The scale consists of 4-items designed to categorise individuals into the five stages of change: pre-contemplation, contemplation, preparation, action, maintenance, based on the Stages of Motivational Readiness for Change Model.
Measured: Baseline, 6 months, 12 months and 24 months upon randomisation.
Health Behaviour: Sleep Quality and Duration
Change in Sleep Quality and Duration will be assessed using the Pittsburgh Sleep Quality Index (PSQI) and wearable-derived metrics.
The scale consists of 19-items across seven components: (1) sleep duration, (2) sleep disturbance, (3) sleep latency, (4) daytime dysfunction, (5) sleep efficiency, (6) sleep quality, and (7) sleep medication usage. Each component will yield a score from 0 - 3, and will be tallied to yield a score from 0 - 21, with higher scores indicating worse sleep quality.
Good sleep quality: 0 - 5 Poor sleep quality: 6 - 21
Measured: Baseline, 6 months, 12 months and 24 months upon randomisation.
Health Behaviour: Sleep (Wearable)
Change in sleep-related wearable data
Measured: Baseline, 6 months, 12 months and 24 months upon randomisation
Health Behaviour: Perceived Stress
Change in perceived stress will be assessed using the Perceived Stress Scale-10 (PSS-10).
The scale consists of 10 items rated on a 5-point Likert scale (0 - 4, 0 = Never; 4 = Very often), totalling a score of 40.
The following score range will be used:
Low stress: 0 - 13 Moderate stress: 14 - 26 High stress: 27 - 40
Measured: Baseline, 6 months, 12 months and 24 months upon randomisation.
Health Behaviour: Social Support
Change in social support scores will be assessed using the Multidimensional Scale of Perceived Social Support (MSPSS). It consists of 12-items on a 7-point Likert scale ranging from 1 (very strongly disagree) to 5 (very strongly agree), for a maximum possible score of 84. A higher score will indicate higher perceived social support.
Measured: Baseline, 6 months, 12 months and 24 months upon randomisation.
Health Behaviour: Medication Adherence
Change in medication adherence will be assessed using the Medication Adherence Report Scale (MARS).
The scale consists of 5-items on a 5-point Likert scale ranging from 1 (never) to 5 (always), with total scores ranging between 5 - 25. Higher scores indicate higher medication adherence.
Measured: Baseline, 6 months, 12 months and 24 months upon randomisation.
Health Behaviour: Dietary Behaviour
Change in dietary behaviour will be assessed by the Health Promotion Board Singapore Dietary Questionnaire published in the 2010 National Nutrition Survey.
The scale consists of 8 items assessing the consumption frequency of fruits and vegetables, wholemeal products, sweetened drinks and food bought from eateries.
Measured: Baseline, 6 months, 12 months and 24 months upon randomisation.
Health-related quality of life
Change in health-related quality of life will be assessed using the EQ-5D-5L. The EQ-5D-5L questionnaire will be used to evaluate the health-related quality of life of an individual to derive a 5-digit health profile code (e.g. 11211) and utility score (0 = worse than death; 1 = full health).
Measured: Baseline, 6 months, 12 months, 24 months from enrolment.
Work Productivity and Activity Impairment Questionnaire: General Health V2.0 (WPAI)
Work Productivity and Activity Impairment Questionnaire: General Health V2.0 will be used to assess absenteeism, presenteeism, and work productivity loss.
Activity impairment will be measured on a 0-10 scale, with 0 representing no problems and 10 representing severe problems. Total work impairment will be multiplied by the hourly wage to derive the valuation. This will make up part of indirect costs, which will be used for cost effectiveness analysis.
Measured: 6 months, 12 months and 24 months upon randomisation.
Cost-Effectiveness Analysis (CEA)
Cost effectiveness Analysis (CEA) will be assessed via the incremental cost effectiveness ratio (ICER).
Below details the steps required for conducting CEA:
- Direct costs will adopt a healthcare system perspective, while indirect costs will be from a societal perspective.
- Quality-adjusted life years (QALY) will be derived from a cost-survey analysis (direct costs: healthcare resources used will be valued using Singapore-specific unit costs; indirect costs: WPAI questionnaire and informal healthcare costs) and EQ-5D-5L (Singapore-specific value set).
- ICER will be derived from the difference in mean costs divided by the difference in QALY between the intervention and the control group.
Measured: 6 months, 12 months and 24 months upon randomisation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Myocardial FibrosisStudies of the same condition, open and under way.
- More trials run by National University of SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart Centre Singapore
- Responsible party
- Principal investigator, Wang Wenru, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07530562
- Sponsor's protocol ID
- 2024-3874
- Other IDs
- OFLCG22may-0010
- Status last verified
- Apr 2026
- First submitted
- 17 Mar 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Due to the extensiveness of the clinical parameters and self-reported data, there could be exploratory analyses conducted in the future. As such, there are no current plans to share IPD.
Publications
Wang K, Deng Y, Xiao H. Exercise and cardiac fibrosis. Current Opinion in Physiology. 2023;31(100630)doi:https://doi.org/10.1016/j.cophys.2022.100630
Gonzalez A, Lopez B, Ravassa S, San Jose G, Latasa I, Butler J, Diez J. Myocardial Interstitial Fibrosis in Hypertensive Heart Disease: From Mechanisms to Clinical Management. Hypertension. 2024 Feb;81(2):218-228. doi: 10.1161/HYPERTENSIONAHA.123.21708. Epub 2023 Dec 12.
PubMed 38084597Lawson CA, Zaccardi F, Squire I, Okhai H, Davies M, Huang W, Mamas M, Lam CSP, Khunti K, Kadam UT. Risk Factors for Heart Failure: 20-Year Population-Based Trends by Sex, Socioeconomic Status, and Ethnicity. Circ Heart Fail. 2020 Feb;13(2):e006472. doi: 10.1161/CIRCHEARTFAILURE.119.006472. Epub 2020 Feb 14.
PubMed 32059630Dai H, Bragazzi NL, Younis A, Zhong W, Liu X, Wu J, Grossman E. Worldwide Trends in Prevalence, Mortality, and Disability-Adjusted Life Years for Hypertensive Heart Disease From 1990 to 2017. Hypertension. 2021 Apr;77(4):1223-1233. doi: 10.1161/HYPERTENSIONAHA.120.16483. Epub 2021 Feb 15.
PubMed 33583201
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Health Coach-Led Digital Lifestyle Intervention (HEALDI) for the Regression of Diffuse Myocardial Fibrosis: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07530562
- Acronym / sponsor ID
- 2024-3874
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- National Heart Centre Singapore
- Study start
- Apr 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 15 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Specific Study Aims
- To compare the effectiveness of HEALDI on change in diffuse myocardial fibrosis, ambulatory blood pressure, with secondary outcomes including multi-organ clinical parameters (e.g. blood tests, liver and brain imaging) and patient-reported outcomes (e.g. physical activity, dietary practices, perceived stress, sleep quality, medication adherence, social support, psychological health, and health-related quality of life).
- Examine the cost-effectiveness of HEALDI intervention.
- Explore the perceptions of the individuals with HHD and health coaches regarding HEALDI.
Hypotheses
It is hypothesised that participants who received the HEALDI intervention, compared to the control group will have:
- Greater regression in diffuse myocardial fibrosis;
- Greater improvement in ambulatory blood pressure;
- Improved multi-organ clinical paramaters;
- Greater adoption and sustained adherence to health behaviours;
- Better quality of life;
- Lower cost to participants and hospitals.
HEALDI Intervention The HEALDI intervention is a 12-month, AI-assisted, health coach-led digital lifestyle intervention comprising a wearable device, HEALDI mobile application, health coach web portal, and administrative web portal. The system functions as an integrated platform to facilitate interaction between participants and health coaches, supporting personalised lifestyle modification.
Participants will access the HEALDI mobile application via their personal smartphones and will be provided with a wearable device that continuously collects activity and physiological data. These data, together with participant-entered health metrics (e.g., blood pressure, medication), will be synchronised to a secure cloud server and made available on the health coach portal to inform coaching sessions, including goal setting and progress review.
Certified health coaches will deliver 30-45-minute remote coaching sessions over 12 months: weekly during the first month, biweekly for the subsequent 5 months, and monthly for the remaining 6 months.
Data Analysis Data will be analysed using IBM SPSS Statistics Version 29.0, with two-tailed p<0.05 indicating statistical significance. Analyses will follow the intention-to-treat principle. Baseline categorical variables will be compared using Chi-squared or Fisher's exact tests, and continuous variables using independent t-tests or Mann-Whitney U tests, depending on normality. Linear mixed models will assess repeated continuous outcomes, and generalized estimating equations (GEE) will be used for ordinal outcomes. Descriptive analyses will summarise utilisation of the mobile app, wearable adherence, and coaching engagement.
Qualitative interviews will be audio-recorded, transcribed, and analysed thematically using Braun and Clarke's six-step framework. Two independent coders will familiarise themselves with the data, generate initial codes and iteratively refine them through discussion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HEALDI Intervention Group | Experimental | Other: HEALDI InterventionA 12-month, AI-assisted, health coach-led digital lifestyle intervention where participants will receive a wearable, HEALDI mobile app and remote health coaching sessions. |
| Control Group | No intervention | –Participants will receive a wearable and basic mobile app without intervention features, used solely for data collection. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HEALDI InterventionProposed Mobile application features include: educational content on HHD and lifestyle behaviours (e.g., physical activity, nutrition, stress, sleep), AI-driven exercise recommendations (frequency, intensity, duration, and type), reviewed and approved by health coaches prior to delivery, Health logging (e.g., blood pressure, medication), Personalised dashboard displaying wearable and self-reported data, Goal setting and progress tracking (short- and long-term), Behavioural nudges (AI-driven and rule-based), Messaging function to facilitate communication with health coaches. Health coaching session involve personalised goal setting and review. | Other | HEALDI Intervention Group |
Primary outcome
Regression of diffuse myocardial fibrosis
Time frame: Baseline and 12 months upon randomisation
Change in indexed interstitial volume assessed by cardiovascular magnetic resonance
39 secondary outcomes
Blood pressure
Time frame: Baseline and 12 months upon randomisation
Left ventricular function
Time frame: Baseline and 12 months upon randomisation.
Left ventricular mass
Time frame: Baseline and 12 months upon randomisation.
Left ventricular volume
Time frame: Baseline and 12 months upon randomisation.
Diastolic and systolic function
Time frame: Baseline and 12 months (upon randomisation)
Valvular function
Time frame: Baseline and 12 months (upon randomisation).
Heart function
Time frame: Baseline and 12 months upon randomisation
First occurrence of cardiovascular event
Time frame: 2 years
Markers of liver fat, inflammation and stiffness
Time frame: Baseline, 12 months and 24 months upon randomisation
Markers of liver fat, inflammation and stiffness
Time frame: Baseline and 12 months upon randomisation.
Brain structure
Time frame: Baseline, 12 months and 24 months upon randomisation.
Cognitive function
Time frame: Baseline and 12 months upon randomisation.
Cardiac and inflammatory markers
Time frame: Baseline, 12 months and 24 months
Circulating biomarkers of inflammation and fibrosis
Time frame: Baseline and 12 months upon randomisation.
Liver function tests
Time frame: Baseline, 12 months and 24 months from randomisation
Lipid profile
Time frame: Baseline, 12 months and 24 months upon randomisation
Renal function markers
Time frame: Baseline, 12 months and 24 months from randomisation
Glycemic control
Time frame: Baseline, 12 months and 24 months upon randomisation.
Body Mass Index
Time frame: Baseline, 12 months and 24 months upon randomisation.
Body composition: Body fat
Time frame: Baseline and 12 months upon randomisation.
Body composition: Muscle Mass
Time frame: Baseline and 12 months upon randomisation.
Body composition: Total body water
Time frame: Baseline and 12 months upon randomisation.
Waist Circumference
Time frame: Baseline, 12 months and 24 months upon randomisation.
Energy expenditure
Time frame: Baseline and 12 months upon randomisation.
Depressive symptoms
Time frame: Baseline, 6 months, 12 months and 24 months upon enrolment.
Anxiety symptoms
Time frame: Baseline, 6 months, 12 months and 24 months upon enrolment.
Health Behaviour: Physical Activity (Wearable)
Time frame: Baseline, 6 months, 12 months and 24 months upon randomisation.
Health Behaviour: Physical Activity (IPAQ-SF)
Time frame: Baseline, 6 months, 12 months and 24 months upon randomisation.
Health Behaviour: Physical Activity (MPAM-R)
Time frame: Baseline, 6 months, 12 months and 24 months upon randomisation.
Health Behaviour: Physical Activity (Stage of Change for Physical Activity Questionnaire)
Time frame: Baseline, 6 months, 12 months and 24 months upon randomisation.
Health Behaviour: Sleep Quality and Duration
Time frame: Baseline, 6 months, 12 months and 24 months upon randomisation.
Health Behaviour: Sleep (Wearable)
Time frame: Baseline, 6 months, 12 months and 24 months upon randomisation
Health Behaviour: Perceived Stress
Time frame: Baseline, 6 months, 12 months and 24 months upon randomisation.
Health Behaviour: Social Support
Time frame: Baseline, 6 months, 12 months and 24 months upon randomisation.
Health Behaviour: Medication Adherence
Time frame: Baseline, 6 months, 12 months and 24 months upon randomisation.
Health Behaviour: Dietary Behaviour
Time frame: Baseline, 6 months, 12 months and 24 months upon randomisation.
Health-related quality of life
Time frame: Baseline, 6 months, 12 months, 24 months from enrolment.
Work Productivity and Activity Impairment Questionnaire: General Health V2.0 (WPAI)
Time frame: 6 months, 12 months and 24 months upon randomisation.
Cost-Effectiveness Analysis (CEA)
Time frame: 6 months, 12 months and 24 months upon randomisation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- BackgroundWang K, Deng Y, Xiao H. Exercise and cardiac fibrosis. Current Opinion in Physiology. 2023;31(100630)doi:https://doi.org/10.1016/j.cophys.2022.100630
- Background: PubMed 38084597Gonzalez A, Lopez B, Ravassa S, San Jose G, Latasa I, Butler J, Diez J. Myocardial Interstitial Fibrosis in Hypertensive Heart Disease: From Mechanisms to Clinical Management. Hypertension. 2024 Feb;81(2):218-228. doi: 10.1161/HYPERTENSIONAHA.123.21708. Epub 2023 Dec 12.
- Background: PubMed 32059630Lawson CA, Zaccardi F, Squire I, Okhai H, Davies M, Huang W, Mamas M, Lam CSP, Khunti K, Kadam UT. Risk Factors for Heart Failure: 20-Year Population-Based Trends by Sex, Socioeconomic Status, and Ethnicity. Circ Heart Fail. 2020 Feb;13(2):e006472. doi: 10.1161/CIRCHEARTFAILURE.119.006472. Epub 2020 Feb 14.
- Background: PubMed 33583201Dai H, Bragazzi NL, Younis A, Zhong W, Liu X, Wu J, Grossman E. Worldwide Trends in Prevalence, Mortality, and Disability-Adjusted Life Years for Hypertensive Heart Disease From 1990 to 2017. Hypertension. 2021 Apr;77(4):1223-1233. doi: 10.1161/HYPERTENSIONAHA.120.16483. Epub 2021 Feb 15.
- Individual participant dataSharing planned: Undecided. Due to the extensiveness of the clinical parameters and self-reported data, there could be exploratory analyses conducted in the future. As such, there are no current plans to share IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing HEALDI Intervention in people with Myocardial Fibrosis and Left Ventricle Hypertrophy, run by National University of Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenru Wang, PhD ((65) 66011761, nurww@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regression of diffuse myocardial fibrosis (time frame: Baseline and 12 months upon randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07530562, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.