NCT05556031
Not yet recruiting
Not Applicable
The Reduction of Decompensation and Unnecessary Cardiac Failure Emergency Admissions: Ambulatory Heart Failure Service Model
ConditionsHeart Failure
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Chinese University of Hong Kong
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Clinical outcome
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
The aim of the study is to assess the efficacy of this new ambulatory service model in reducing heart failure hospitalization (HHF), improving clinical as well as functional outcomes of post-discharge patients with Heart Failure of reduced ejection fraction (HFrEF) and Heart failure with preserved Ejection Fraction (HFpEF).
Investigators
Professor Bryan Ping Yen YAN
Professor
Chinese University of Hong Kong
Eligibility Criteria
Inclusion Criteria
- •Dyspnoea (exertional or at rest) and 2 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 ≥300 pg/mL (Patients with AF: NT-proBNP ≥900 pg/mL)
- •Heart failure hospitalization that requires the treatment of a minimum single dose of 40 mg of i.v. furosemide (or equivalent i.v loop diuretics)
- •Ambulatory patients
Exclusion Criteria
- •Cardiogenic shock required inotropics
- •Cardiac mechanical support implantation like LVAD
- •Life expectancy less than 1 year due to underlying significant comorbidities like metastatic cancer or end-stage COPD
- •Haemodynamically severe uncorrected primary cardiac valvular disease planned for surgery or intervention during the course of the study.
- •End stage renal failure or eGFR \<15 mL/min/1.73m2 as measured during index hospitalization or requiring dialysis
Outcomes
Primary Outcomes
Clinical outcome
Time Frame: 90 days
A composite of all-cause mortality, number of heart failure events (including hospitalization for heart failure (HHF), urgent heart failure visits and unplanned outpatient visits), time to first heart failure event will be aggregated to evaluate overall clinical outcome
Secondary Outcomes
- Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS)(1 year)
- NT-proBNP level(1 year)
- Risk of Heart failure(1 year)
- Quality adjusted Life years gained(1 year)
- Change in overall Cardiac function(90 days)
- Major Adverse Cardiovascular Event(1 year)
- Hypertensive heart failure (HHF)(90 days after initial hospital discharge)
- Change in 6 minute hall walk (6MHW)(90 days)
Study Sites (1)
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