NCT07016815Recruiting
Telemonitoring to Optimize Medication Titration for Heart Failure: a Feasibility Study
Telemonitoring to Optimize Medication Titration for Heart Failure (TOM-HF): a Feasibility Study
Source: ClinicalTrials.gov · Last updated 30 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Problem: Aggressive titration of guideline-directed medical therapy is the cornerstone of heart failure management to reduce heart failure related hospitalization and mortality. A major hurdle to uptitration of medical therapy is the safety concerns of these medications namely hypotension and bradycardia. Early and frequent clinic visits will be required to ensure the safe uptitration of these treatments, but this is difficult to implement in daily practice due to resources constrain. Advancement in wearable and wireless technologies enables remote and continuous monitoring of patients in ambulatory setting and potentially achieving safe and effective uptitration of medical therapy while minimizing the demand on the current healthcare system. However, access to these wearable and wireless technologies is not universal and patients in low socio-economic tiers might be deprived of the opportunity to realize the benefits from these technologies. Solution: This project therefore aims to develop a mobile platform and to provide wearable devices to patients with acute heart failure to improve and optimize the use of guideline-directed medical therapy in these patients. Impacts: The finding from this project will inform future heart failure management and help to implement and integrate telemedicine in the vulnerable stage of heart failure care. It will help to maximize healthcare resources utilization and help to bridge the gap between those who have limited access to healthcare services. The model of heart failure care generated from this project can be propagate and replicated in general patients care.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 27 May 2025
- Start date
- 1 Jun 2025
- Primary completion date
- 1 Dec 2028
- Lead sponsor
- Chinese University of Hong Kong
- Diseases
- Heart failure
- NCT number
- NCT07016815
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 1 Jun 2025 to the primary completion date, 1 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Documented history of HF with previous HF admission.
- Cardiac interventions (listed below) in past 30 days prior or planned during the study period.
- Major cardiac surgery, or Tran Aortic Valve Implantation, or Percutaneous Coronary Intervention, or MitraClip
- Current or expected heart transplant, LVAD, IABP, or patients with planned inotropic support in an outpatient setting.
Other illness
- Haemodynamically severe uncorrected primary cardiac valvular disease.
- Documented allergy or intolerance to beta-blocker, renin-angiotensin-aldosterone system inhibitor, mineralocortical receptor antagonist, or angiotensin receptor/neprilysin inhibitor.
- Psychiatric or severe neurological disorder, cirrhosis, or active malignancy leading to a life expectancy \< 6 months.
Lab values
- eGFR \<30 mL/min/1.73m2 as measured during index hospitalization (latest measurement before randomization) or patients requiring dialysis.
Other
- Current hospitalization for acute HF primarily triggered by pulmonary embolism, cerebrovascular accident, or acute MI.
- Pregnant or nursing women.
- Non-ambulatory patients.
- Patients who are unable to operate simple electronic devices; or unable to assess a mobile network service in the place of residence.
- Patients who are unable to given written informed consent.
Who the study is looking for
- 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.
- NT-proBNP which is measured within the same hospitalization with level \>300ng/L or 600ng/L if ongoing atrial fibrillation/atrial flutter.
- Left ventricular ejection fraction less than 40% by any form of imaging.
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Prince of Wales Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.