Remote monitoring to speed safe heart-failure medication adjustments

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This feasibility project uses wrist-worn heart-rate/activity monitors, a Bluetooth weight scale with bioimpedance, a Bluetooth blood-pressure device, and a smartphone app to remotely monitor patients after an acute HFrEF hospitalization. Clinicians will use continuous remote data to guide more rapid up-titration of guideline-directed medical therapy while watching for hypotension or bradycardia. The protocol targets earlier and more frequent medication adjustments than usual care to try to increase the proportion of patients reaching target drug doses without added safety events. The work is being conducted at Prince of Wales Hospital in Hong Kong and explicitly considers local resource limits and patient access to wearable technology.

Why it matters

Who can join: the full rules

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.

Where it's running

• Prince of Wales Hospital
  Hong Kong, Hong Kong, Hong Kong Recruiting
• Prince of Wales Hospital
  Hong Kong, Shatin, Hong Kong Recruiting

Study contacts

• Study coordinator: Daniel Xu
• Email: gtan@cuhk.edu.hk
• Phone: 852+35051518

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Ring-style blood pressure bracelet test compared with 24-hour monitoring in people with HFrEF

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.