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Not yet recruiting NCT05556031

Ambulatory Heart Failure Service Model Study

— Observational Heart Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standard care.
Who it may be relevant to
Registry conditions: Heart Failure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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).

Interventions

  • Other Standard care
    Standard clinical care

Primary outcome measures

  • Clinical outcome [Time frame: 90 days]
Secondary outcome measures (8)
  • Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) [Time frame: 1 year]
  • NT-proBNP level [Time frame: 1 year]
  • Risk of Heart failure [Time frame: 1 year]
  • Change in overall Cardiac function [Time frame: 90 days]
  • Major Adverse Cardiovascular Event [Time frame: 1 year]
  • Hypertensive heart failure (HHF) [Time frame: 90 days after initial hospital discharge]
  • Quality adjusted Life years gained [Time frame: 1 year]
  • Change in 6 minute hall walk (6MHW) [Time frame: 90 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Hong Kong · 1 center
  • The Chinese University of Hong Kong — Shatin

Identifiers

NCT: NCT05556031 · 2022.245

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗