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New treatment option for Acute Heart Failure With Reduced Left Ventricular Ejection Fraction
Official title Telemonitoring to Optimize Medication Titration for Heart Failure: a Feasibility Study
ClinicalTrials.gov ID: NCT07016815
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hong Kong, Hong Kong, Hong Kong
- Hong Kong, Shatin, Hong Kong
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hong Kong, Hong Kong, Hong Kong; Hong Kong, Shatin, Hong Kong. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.