Ambulatory Heart Failure Service Model Study

Not yet recruiting

• Conditions: Heart Failure
• Interventions: Other: Standard care

• Registration Number: NCT05556031
• Lead Sponsor: Chinese University of Hong Kong

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-09-15
• Study First Submitted QC: 2022-09-22
• Last Update Submitted: 2022-09-22
• Study First Posted: 2022-09-27
• Last Update Posted: 2022-09-27
• Study Start: 2022-10
• Primary Completion: 2027-10
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
REDUCE	Standard care	Standard care

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
NT-proBNP level	1 year	Change from baseline in NT-proBNP level
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.
Risk of Heart failure	1 year	Change in NYHA class, ELAN-HF score, and MAGGIC Risk score. and Seattle Heart Failure Model Risk Prediction
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 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
Change in 6 minute hall walk (6MHW)	90 days	Change in 6 minute hall walk (6MHW) result compared with baseline

Trial Locations

Locations (1)

The Chinese University of Hong Kong; 🇭🇰 Shatin, Hong Kong