Ambulatory Heart Failure Service Model Study

Study Overview
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Brief Summary
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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).

Official Title
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The Reduction of Decompensation and Unnecessary Cardiac Failure Emergency Admissions: Ambulatory Heart Failure Service Model

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Standard care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| REDUCE<br>Standard care | Other: Standard care<br>* Standard clinical care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcome | 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 | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) | Change from baseline in KCCQ-TSS, higher score reflects better outcome, Maximum score 100. | 1 year | 
| NT-proBNP level | Change from baseline in NT-proBNP level | 1 year | 
| Risk of Heart failure | Change in NYHA class, ELAN-HF score, and MAGGIC Risk score. and Seattle Heart Failure Model Risk Prediction | 1 year | 
| Change in overall Cardiac function | 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 | 90 days | 
| Major Adverse Cardiovascular Event | Time to first occurrence of cardiovascular death or heart failure event | 1 year | 
| Hypertensive heart failure (HHF) | Occurrence of HHF | 90 days after initial hospital discharge | 
| Quality adjusted Life years gained | Cost effectiveness of ambulatory heart failure service for heart failure events avoided and quality adjusted life years (QALY) gained. | 1 year | 
| Change in 6 minute hall walk (6MHW) | Change in 6 minute hall walk (6MHW) result compared with baseline | 90 days |