Ambulatory Heart Failure Service Model Study

N/ANot Yet RecruitingNCT05556031

Chinese University of Hong Kong500 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

500

Conditions

Heart Failure

Interventions

Standard careOTHER

Standard clinical care

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

The Chinese University of Hong Kong

Shatin, Hong Kong

Outcomes

Primary Outcomes

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

Time frame: 90 days

Secondary Outcomes

Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS)

Change from baseline in KCCQ-TSS, higher score reflects better outcome, Maximum score 100.

Time frame: 1 year

NT-proBNP level

Change from baseline in NT-proBNP level

Time frame: 1 year

Risk of Heart failure

Change in NYHA class, ELAN-HF score, and MAGGIC Risk score. and Seattle Heart Failure Model Risk Prediction

Time frame: 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

Time frame: 90 days

Major Adverse Cardiovascular Event

Time to first occurrence of cardiovascular death or heart failure event

Time frame: 1 year

Hypertensive heart failure (HHF)

Occurrence of HHF

Time frame: 90 days after initial hospital discharge

Central Contacts

Daniel Xu

CONTACT

35051518 danielxu@cuhk.edu.hk

Data from ClinicalTrials.gov

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