REDUCE-HF: Ambulatory Heart Failure Service Model Study
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| REDUCE Standard care |
Other: Standard care
Standard clinical care
|
Outcome Measures
Primary Outcome Measures
- Clinical outcome [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 Outcome Measures
- Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) [1 year]
Change from baseline in KCCQ-TSS, higher score reflects better outcome, Maximum score 100.
- NT-proBNP level [1 year]
Change from baseline in NT-proBNP level
- Risk of Heart failure [1 year]
Change in NYHA class, ELAN-HF score, and MAGGIC Risk score. and Seattle Heart Failure Model Risk Prediction
- Change in overall Cardiac function [90 days]
Evaluated by left ventricular ejection fraction (LVEF), left ventricle volume index, global longitudinal strain (GLS), E/E' ratio, left atrial (LA) volume index and LA GLS, inferior vena cava (IVC) size, right ventricular systolic pressure (RVSP) and functional mitral regurgitation (MR) will be aggregated to represent the overall cardiac function
- Major Adverse Cardiovascular Event [1 year]
Time to first occurrence of cardiovascular death or heart failure event
- Hypertensive heart failure (HHF) [90 days after initial hospital discharge]
Occurrence of HHF
- Quality adjusted Life years gained [1 year]
Cost effectiveness of ambulatory heart failure service for heart failure events avoided and quality adjusted life years (QALY) gained.
- Change in 6 minute hall walk (6MHW) [90 days]
Change in 6 minute hall walk (6MHW) result compared with baseline
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Dyspnoea (exertional or at rest) and 2 of the following signs:
-
Congestion on chest X-ray
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Rales on chest auscultation
-
Clinically relevant oedema (e.g. ≥1+ on a 0 to 3+ scale)
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Elevated jugular venous pressure
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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:
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Cardiogenic shock required inotropics
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Cardiac mechanical support implantation like LVAD
-
Life expectancy less than 1 year due to underlying significant comorbidities like metastatic cancer or end-stage COPD
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Haemodynamically severe uncorrected primary cardiac valvular disease planned for surgery or intervention during the course of the study.
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End stage renal failure or eGFR <15 mL/min/1.73m2 as measured during index hospitalization or requiring dialysis
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Chinese University of Hong Kong | Shatin | Hong Kong | 999077 |
Sponsors and Collaborators
- Chinese University of Hong Kong
Investigators
- Principal Investigator: Bryan Yan, Chinese University of Hong Kong
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022.245