NCT07016815 Telemonitoring to Optimize Medication Titration for Heart Failure: a Feasibility Study
| NCT ID | NCT07016815 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese University of Hong Kong |
| Condition | Acute Heart Failure With Reduced Left Ventricular Ejection Fraction |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2028-12-01 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2025-06-01 with a primary completion date of 2028-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07016815 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Acute Heart Failure With Reduced Left Ventricular Ejection Fraction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07016815 currently recruiting?
Yes, NCT07016815 is actively recruiting participants. Contact the research team at gtan@cuhk.edu.hk for enrollment information.
Where is the NCT07016815 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong, Hong Kong, Hong Kong.
Who is sponsoring the NCT07016815 clinical trial?
NCT07016815 is sponsored by Chinese University of Hong Kong. The trial plans to enroll 80 participants.
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