RECRUITINGINTERVENTIONAL

Telemonitoring to Optimize Medication Titration for Heart Failure: a Feasibility Study

Telemonitoring to Optimize Medication Titration for Heart Failure (TOM-HF): a Feasibility Study

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: 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. Who Should NOT Join This Trial: 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 willing to sign a consent form. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DEVICE

Wearable wrist heart rate and activity monitor

A commercially available smart watch capable of continuous monitoring of heart rate and activities including daily steps count and daily activity level, detection of arrythmia using a proprietary FDA approved algorithm14, and measuring peripheral capillary oxygen saturation will be provided to the patient. Patients will be encouraged to wear the watch as often as possible during daytime and during sleep. Data gathered will be automatically transmitted wirelessly to a cloud-based platform provided by the manufacturer accessible only by the research team and the patient.

DEVICE

Bluetooth enabled body weight scale with bioimpedance analysis

An electronic scale which measures bioimpedance using bioelectrical analysis from foot-to-foot impedance and body fluid percentage (BF%) using a proprietary equation15,16 will be provided to the patients. Patient will be encouraged to measure their bodyweight (BW) and bioimpedance twice per day, one in the morning, and one before bath, with minimal clothing. Both data will be automatically transmitted wirelessly to a cloud-based platform provided by the manufacturer accessible only by the research team and the patients.

DEVICE

Bluetooth enabled electronic blood pressure device

An electronic cuffed arm blood pressure monitor will be provided to the patient with instruction on how to perform proper blood pressure measurement at home16. Patients are encouraged to take at least 2 blood pressure reading daily, one in the morning and one in the evening. Blood pressure reading will be transmitted wirelessly to an online platform provided by the manufacturer accessible only by the research team and the patients.

DEVICE

mobile application

a mobile Application through which data from remote monitoring and wearables will be incorporated, and instruction for medication titration and education on heart failure management will be provided to the patients.

Locations (2)

Prince of Wales Hospital

Hong Kong, Hong Kong, Hong Kong

Prince of Wales Hospital

Hong Kong, Shatin, Hong Kong