Ambulatory Heart Failure Service Model Study

NCT05556031 | Not Yet Recruiting

• 1 other identifier: 2022.245
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

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

  1 year

• NT-proBNP level

  1 year

• Risk of Heart failure

  1 year

• Change in overall Cardiac function

  90 days

• Major Adverse Cardiovascular Event

  1 year

Study Arms (1)

REDUCE

Standard care

Other: Standard care

Interventions

Standard care OTHER

Standard clinical care

REDUCE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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%)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Shatin, 999077, Hong Kong

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Bryan Yan

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Xu

CONTACT

35051518; danielxu@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 27, 2022
• Study Start: October 1, 2022
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: September 27, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)