Ambulatory Heart Failure Service Model Study

Heart Failure Clinical Trial

— REDUCE-HF  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05556031
• Other study ID #: 2022.245
• Status: Not yet recruiting
• Start date: October 2022
• Est. completion date: January 2028

Study information

• Verified date: September 2022
• Source: Chinese University of Hong Kong
• Contact: Daniel Xu
• Phone: 35051518
• Email: danielxu[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: January 2028
• Est. primary completion date: October 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Standard care
Standard clinical care

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong	Shatin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	NT-proBNP level	Change from baseline in NT-proBNP level	1 year
Secondary	Risk of Heart failure	Change in NYHA class, ELAN-HF score, and MAGGIC Risk score. and Seattle Heart Failure Model Risk Prediction	1 year
Secondary	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
Secondary	Major Adverse Cardiovascular Event	Time to first occurrence of cardiovascular death or heart failure event	1 year
Secondary	Hypertensive heart failure (HHF)	Occurrence of HHF	90 days after initial hospital discharge
Secondary	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
Secondary	Change in 6 minute hall walk (6MHW)	Change in 6 minute hall walk (6MHW) result compared with baseline	90 days