Ambulatory Heart Failure Service Model Study (REDUCE-HF)

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Other: Standard care

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• Hong Kong
  • Shatin, Hong Kong, 999077
    • The Chinese University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient with heart failure with preserved ejection fraction (HFpEF, EF > 50%) and heart failure with reduced ejection fraction (HFrEF, EF <50%)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
REDUCE; Standard care	Other: Standard care; Standard clinical care

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2022
• Primary Completion (ANTICIPATED): October 1, 2027
• Study Completion (ANTICIPATED): January 1, 2028

Study Registration Dates

• First Submitted: September 15, 2022
• First Submitted That Met QC Criteria: September 22, 2022
• First Posted (ACTUAL): September 27, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 27, 2022
• Last Update Submitted That Met QC Criteria: September 22, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 2022.245

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No