RecruitingNot ApplicableNCT07016815

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

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


Sponsor

Chinese University of Hong Kong

Enrollment

80 participants

Start Date

Jun 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This feasibility study is testing whether a remote monitoring program using digital devices can help doctors safely and efficiently adjust heart failure medications at home after a patient is newly diagnosed and hospitalized, reducing the need for frequent in-person visits. **You may be eligible if...** - You have been newly diagnosed with heart failure with reduced pumping function (ejection fraction below 40%) during this hospitalization - You have symptoms of fluid buildup (shortness of breath, swelling, or crackling lungs) - Your blood marker for heart failure (NT-proBNP) is significantly elevated **You may NOT be eligible if...** - You have been previously hospitalized for heart failure - Your heart failure was triggered by a pulmonary embolism, stroke, or recent heart attack - You recently had major heart surgery, valve procedure, or coronary stenting - Your kidneys are severely impaired or you require dialysis - You are pregnant or nursing - You are unable to use simple electronic devices or do not have mobile network access at home Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEWearable 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.

DEVICEBluetooth 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.

DEVICEBluetooth 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.

DEVICEmobile 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

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NCT07016815