Remote monitoring to speed safe heart-failure medication adjustments
Telemonitoring to Optimize Medication Titration for Heart Failure (TOM-HF): a Feasibility Study
We will test whether wearables and a mobile app can help doctors safely speed up medication adjustments for people hospitalized with acute HFrEF.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 2 sites (Hong Kong, Hong Kong and 1 other locations) |
| Trial ID | NCT07016815 on ClinicalTrials.gov |
What this trial studies
This feasibility project uses wrist-worn heart-rate/activity monitors, a Bluetooth weight scale with bioimpedance, a Bluetooth blood-pressure device, and a smartphone app to remotely monitor patients after an acute HFrEF hospitalization. Clinicians will use continuous remote data to guide more rapid up-titration of guideline-directed medical therapy while watching for hypotension or bradycardia. The protocol targets earlier and more frequent medication adjustments than usual care to try to increase the proportion of patients reaching target drug doses without added safety events. The work is being conducted at Prince of Wales Hospital in Hong Kong and explicitly considers local resource limits and patient access to wearable technology.
Who should consider this trial
Good fit: Ideal candidates are adults hospitalized with acute decompensated heart failure and LVEF <40% with elevated NT-proBNP who can use or be supported to use wearable devices and a smartphone app and who have not had prior HF admissions.
Not a fit: Patients with prior HF admissions, recent or planned major cardiac interventions, expected transplant/LVAD or circulatory support, or those unable to use the required devices or app are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could help more patients reach guideline-recommended medication doses sooner and more safely, potentially lowering readmissions and improving outcomes.
How similar studies have performed: Intensive follow-up programs like STRONG-HF have shown rapid GDMT up-titration is feasible, and remote monitoring has been used in heart failure, but combining continuous wearable monitoring specifically to drive medication titration remains relatively novel and undertested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Clinical symptoms of Dyspnoea (exertional or at rest) and 1 of the following signs: * Congestion on chest X-ray * Rales on chest auscultation * Clinically relevant oedema (e.g. ≥1+ on a 0 to 3+ scale) * Elevated jugular venous pressure. 2. NT-proBNP which is measured within the same hospitalization with level \>300ng/L or 600ng/L if ongoing atrial fibrillation/atrial flutter. 3. Left ventricular ejection fraction less than 40% by any form of imaging. Exclusion Criteria: 1. Documented history of HF with previous HF admission. 2. Current hospitalization for acute HF primarily triggered by pulmonary embolism, cerebrovascular accident, or acute MI. 3. Cardiac interventions (listed below) in past 30 days prior or planned during the study period. 1. Major cardiac surgery, or Tran Aortic Valve Implantation, or Percutaneous Coronary Intervention, or MitraClip 2. Current or expected heart transplant, LVAD, IABP, or patients with planned inotropic support in an outpatient setting. 4. Haemodynamically severe uncorrected primary cardiac valvular disease. 5. eGFR \<30 mL/min/1.73m2 as measured during index hospitalization (latest measurement before randomization) or patients requiring dialysis. 6. Documented allergy or intolerance to beta-blocker, renin-angiotensin-aldosterone system inhibitor, mineralocortical receptor antagonist, or angiotensin receptor/neprilysin inhibitor. 7. Pregnant or nursing women. 8. Psychiatric or severe neurological disorder, cirrhosis, or active malignancy leading to a life expectancy \< 6 months. 9. Non-ambulatory patients. 10. Patients who are unable to operate simple electronic devices; or unable to assess a mobile network service in the place of residence. 11. Patients who are unable to given written informed consent.
Where this trial is running
Hong Kong, Hong Kong and 1 other locations
- Prince of Wales Hospital — Hong Kong, Hong Kong, Hong Kong (Recruiting)
- Prince of Wales Hospital — Hong Kong, Shatin, Hong Kong (Recruiting)
Study contacts
- Study coordinator: Daniel Xu
- Email: gtan@cuhk.edu.hk
- Phone: 852+35051518
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.