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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Hong Kong Special Administrative Region
Prince of Wales Hospital
RECRUITING
Hong Kong
Prince of Wales Hospital
RECRUITING
Hong Kong
Contact Information
Primary
Daniel Xu
gtan@cuhk.edu.hk
852+35051518
Backup
Kimmy Ho
kimmyho@cuhk.edu.hk
852+35051518
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2029-02-28
Participants
Target number of participants: 80
Treatments
Experimental: Intervention group
Patients randomized to the intervention group will be taught how to operate individual devices of telemonitoring before discharge by the research team. 30 days of all three classes medication up to the targeted dose (as listed below) will be given to the patient with clear labelling and instructions on their administration. Pills of minimal dosage will be provided for easier patient communication and dosage titration. Medication up-titration will be performed over the phone by a senior research nurse according to algorithms as listed below. Patients will also be asked during each phone call regarding the occurrence of any adverse event. The integrated telemonitoring consists of 1. a wearable wrist heart rate and activity monitor, 2.a blue-tooth enabled body weight scale with bioimpedance analysis, and 3. a blue-tooth enabled electronic blood pressure device.
No_intervention: Control Group
Patient will be seen at clinic for physician consultation every 30 days after discharge as per current practice until the end of follow-up which is at 90 days. Guidance on medication up-titration similar to intervention group will be provided to the physician. Medication titration will be performed during clinic consultation at the physician's discretion
Related Therapeutic Areas
Sponsors
Leads: Chinese University of Hong Kong

This content was sourced from clinicaltrials.gov