Heart FailureREDUCE-HFNCT05556031
Ambulatory Heart Failure Service Model Study
An observational study of Heart Failure, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 500 participants
- Where
- 1 siteHong Kong
- Study dates
- Oct 2022to Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with heart failure with preserved ejection fraction (HFpEF, EF > 50%) and heart failure with reduced ejection fraction (HFrEF, EF <50%)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Reduction of Decompensation and Unnecessary Cardiac Failure Emergency Admissions: Ambulatory Heart Failure Service Model
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
- Being tested
- Standard care
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard careOther
Standard clinical care
| Study group | Role | What they receive |
|---|---|---|
| REDUCE | Standard care Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 days
Secondary outcomes (8)
Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS)
Change from baseline in KCCQ-TSS, higher score reflects better outcome, Maximum score 100.
Measured: 1 year
NT-proBNP level
Change from baseline in NT-proBNP level
Measured: 1 year
Risk of Heart failure
Change in NYHA class, ELAN-HF score, and MAGGIC Risk score. and Seattle Heart Failure Model Risk Prediction
Measured: 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
Measured: 90 days
Major Adverse Cardiovascular Event
Time to first occurrence of cardiovascular death or heart failure event
Measured: 1 year
Hypertensive heart failure (HHF)
Occurrence of HHF
Measured: 90 days after initial hospital discharge
Quality adjusted Life years gained
Cost effectiveness of ambulatory heart failure service for heart failure events avoided and quality adjusted life years (QALY) gained.
Measured: 1 year
Change in 6 minute hall walk (6MHW)
Change in 6 minute hall walk (6MHW) result compared with baseline
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study startOct 2022 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Bryan Ping Yen YAN, Chinese University of Hong Kong
- Investigators
- Bryan Yan, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05556031
- Sponsor's protocol ID
- 2022.245
- Acronym
- REDUCE-HF
- Status last verified
- Sep 2022
- First submitted
- 15 Sep 2022
- Last updated
- 27 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reduction of Decompensation and Unnecessary Cardiac Failure Emergency Admissions: Ambulatory Heart Failure Service Model
- ClinicalTrials.gov ID
- NCT05556031
- Acronym / sponsor ID
- REDUCE-HF / 2022.245
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 27 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| REDUCE | – | Other: Standard careStandard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with heart failure with preserved ejection fraction (HFpEF, EF > 50%) and heart failure with reduced ejection fraction (HFrEF, EF <50%)
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard careStandard clinical care | Other | REDUCE |
Primary outcome
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
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bryan Yan principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Xu (35051518, danielxu@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical outcome (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2022.