Telemonitoring to Optimize Medication Titration for Heart Failure: a Feasibility Study
Recruiting · NCT07016815 · Interventional (participants receive a specific treatment) · Lead sponsor: Chinese University of Hong Kong
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- Documented history of HF with previous HF admission.
- Current hospitalization for acute HF primarily triggered by pulmonary embolism, cerebrovascular accident, or acute MI.
- 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.
- Haemodynamically severe uncorrected primary cardiac valvular disease.
- eGFR \<30 mL/min/1.73m2 as measured during index hospitalization (latest measurement before randomization) or patients requiring dialysis.
- Documented allergy or intolerance to beta-blocker, renin-angiotensin-aldosterone system inhibitor, mineralocortical receptor antagonist, or angiotensin receptor/neprilysin inhibitor.
- Pregnant or nursing women.
- Psychiatric or severe neurological disorder, cirrhosis, or active malignancy leading to a life expectancy \< 6 months.
- 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.
Where it is running
2 locations listed.
- Prince of Wales Hospital - Hong Kong, Hong Kong, Hong Kong
- Prince of Wales Hospital - Hong Kong, Shatin, Hong Kong