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NCT Number: NCT05556031

Ambulatory Heart Failure Service Model Study

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Chinese University of Hong Kong

Shatin, 999077, Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard care

Other

Standard clinical care

Primary outcomes

  1. Clinical outcome

    Time frame: 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 outcomes

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

    Time frame: 1 year

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

  2. NT-proBNP level

    Time frame: 1 year

    Change from baseline in NT-proBNP level

  3. Risk of Heart failure

    Time frame: 1 year

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

  4. Change in overall Cardiac function

    Time frame: 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

  5. Major Adverse Cardiovascular Event

    Time frame: 1 year

    Time to first occurrence of cardiovascular death or heart failure event

  6. Hypertensive heart failure (HHF)

    Time frame: 90 days after initial hospital discharge

    Occurrence of HHF

  7. Quality adjusted Life years gained

    Time frame: 1 year

    Cost effectiveness of ambulatory heart failure service for heart failure events avoided and quality adjusted life years (QALY) gained.

  8. Change in 6 minute hall walk (6MHW)

    Time frame: 90 days

    Change in 6 minute hall walk (6MHW) result compared with baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Xu

CONTACT

[email protected]

35051518

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Acronym: REDUCE-HF

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Sep 27, 2022
Registry last updated
Sep 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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