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Heart Failure With Reduced Ejection FractionTRANS-HFNCT04900584

Optimize Heart Failure Care During TRANSitional Period in Patients With Acute Heart Failure.

A study testing Checklist, Education and Telephone monitoring in people with Heart Failure With Reduced Ejection Fraction and Acute Heart Failure, run by Wonju Severance Christian Hospital at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The period of about a month after the discharge of acute heart failure patients is defined as a transition time. During this period, the patient has a high mortality rate and a readmission rate because the patient is not stabilized. Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
Checklist, Education and Telephone monitoring
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,009 participants
Where
1 siteSouth Korea
Study dates
23 Jun 2020to 28 Feb 2023
Phase
Interventional
Are there results?
None posted in the registry

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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Symptoms of heart failure
  • Signs of heart failure
  • Lung congestion in Chest-X-ray
  • Objective finding of structural and/or functional disorder of the heart or elevated natriuretic peptide levels
  • Left ventricular ejection fraction less than 40%

Who cannot join

  • Patients younger than 19 years old
  • Patients who do no consent

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Wonju Severance Christian Hospital,

    Wŏnju, Gangwon-do, 26426

Other trials in South Korea

About this study

Official title: A Prospective Randomized Multicenter Controlled Study to Optimize Heart Failure Care During TRANSitional Period in Patients With Acute Heart Failure With Reduced Ejection Fraction.

The period of about a month after the discharge of acute heart failure patients is defined as a transition time. During this period, the patient has a high mortality rate and a readmission rate because the patient is not stabilized. In the United States and Europe, the readmission rate is more than 25% within 30 days, and the mortality rate within 30 days after discharge is three times that of patients with chronic heart failure.

The TRANS-HF is a prospective, randomized, multi-center, controlled study, which enrolls patients with acute heart failure with reduced ejection fraction.

The objective of TRANS-HF is to improve GAI at six months through three interventions: pre-discharge checklist, heart failure education, and telephone monitoring before the first outpatient visit.

Being tested
Checklist, Education, Telephone monitoring
Keywords
Acute Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ChecklistOther

    Checklist of guideline-based treatment before discharge

  • EducationOther

    Heart failure education before discharge

  • Telephone monitoringOther

    Telephone monitoring after discharge

Study groups in NCT04900584
Study groupRoleWhat they receive
Intervention groupExperimentalThe intervention group is managed by applying all three types of intervention.
Receives: Other: Checklist; Other: Education; Other: Telephone monitoring
non-Intervention groupNo interventionNon-intervention group is managed by conventional heart failure treatment.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Guideline adherence indicator at 6months

    the point of Guideline adherence indicator. Definition of GAI strata : Level of guideline-adherent treatment will be measured by guideline adherence indicator (GAI) such as 0/3, 1/3, 2/3, and 3/3. This GAI data will be obtained once after all prescription data has been collected. It will include whether or not prescribed medication of ≥50% of target dose : 0 points for non-prescription in the absence of contra-indications, 0.5 points for use of <50% of target dosage (<100% of target dose for MRA as the majority of patients were treated with ≥50% of target dose of MRA) or 1 point for use in ≥50% of target dosage (target dose for MRA). Non-administration of recommended drugs due to specific contraindications or intolerance will be scored as adherence to guidelines.

    Measured: 6months

Secondary outcomes (11)

  1. Guideline adherence indicator at discharge

    the point of Guideline adherence indicator. Definition of GAI strata : Level of guideline-adherent treatment will be measured by guideline adherence indicator (GAI) such as 0/3, 1/3, 2/3, and 3/3. This GAI data will be obtained once after all prescription data has been collected. It will include whether or not prescribed medication of ≥50% of target dose : 0 points for non-prescription in the absence of contra-indications, 0.5 points for use of <50% of target dosage (<100% of target dose for MRA as the majority of patients were treated with ≥50% of target dose of MRA) or 1 point for use in ≥50% of target dosage (target dose for MRA). Non-administration of recommended drugs due to specific contraindications or intolerance will be scored as adherence to guidelines.

    Measured: 0 day (at discharge)

  2. Guideline adherence indicator at 1month

    the point of Guideline adherence indicator. Definition of GAI strata : Level of guideline-adherent treatment will be measured by guideline adherence indicator (GAI) such as 0/3, 1/3, 2/3, and 3/3. This GAI data will be obtained once after all prescription data has been collected. It will include whether or not prescribed medication of ≥50% of target dose : 0 points for non-prescription in the absence of contra-indications, 0.5 points for use of <50% of target dosage (<100% of target dose for MRA as the majority of patients were treated with ≥50% of target dose of MRA) or 1 point for use in ≥50% of target dosage (target dose for MRA). Non-administration of recommended drugs due to specific contraindications or intolerance will be scored as adherence to guidelines.

    Measured: 1month after discharge

  3. KCCQ(The Kansas City Cardiomyopathy Questionnaire) at discharge

    the score of the Kansas City Cardiomyopathy Questionnaire

    Measured: 0 day (at discharge)

  4. KCCQ(The Kansas City Cardiomyopathy Questionnaire) at 6 months

    the score of the Kansas City Cardiomyopathy Questionnaire

    Measured: 6 months after discharge

  5. EQ-5D(The EuroQoL five-dimensional instrument) at discharge

    the score of the EuroQoL five-dimensional instrument

    Measured: 0 day (at discharge)

  6. EQ-5D(The EuroQoL five-dimensional instrument) at 6 months

    the score of The EuroQoL five-dimensional instrument

    Measured: 6 months after discharge

  7. All-cause death

    incidence rate (%) of death from any cause

    Measured: up to 6 months

  8. Heart failure rehospitalization

    incidence rate (%) of the first rehospitalization due to heart failure

    Measured: up to 6 months

  9. Cardiovascular death

    incidence rate (%) of death due to heart failure, arrhythmia and cerebrovascular event.

    Measured: up to 6 months

  10. Cardiovascular rehospitalization

    incidence rate (%) of the first rehospitalization due to heart failure, arrhythmia, and cerebrovascular event.

    Measured: up to 6 months

  11. Composite end-point

    incidence rate (%) of all-cause death and the first rehospitalization rehospitalization

    Measured: up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2021
  2. Study start23 Jun 2020
  3. Primary completion31 Oct 2022 (estimated)
  4. Study completion28 Feb 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,009 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04900584
Sponsor's protocol ID
2019ER630301
Acronym
TRANS-HF
Status last verified
May 2022
First submitted
13 Aug 2020
Last updated
1 Jun 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Son JW, Cho DH, Kim SE, Choi J, Choi DJ, Cho HJ, Lee CJ, Choi JO, Lee SE, Kim EJ, Chung WJ, Youn JC, Bae DH, Park JH, Kim KH, Kim IC, Choi JH, Lee S, Kim H, Yoo BS. Effectiveness of an Intervention to Improve Guideline-Directed Medications for Patients With Acute Heart Failure: A Randomized Clinical Trial. J Am Heart Assoc. 2026 May 19;15(10):e044747. doi: 10.1161/JAHA.125.044747. Epub 2026 May 6.

    PubMed 42089166

Questions about this trial

What is this clinical trial studying?

A study testing Checklist, Education and Telephone monitoring in people with Heart Failure With Reduced Ejection Fraction and Acute Heart Failure, run by Wonju Severance Christian Hospital at 1 site in South Korea.

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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 1 Jun 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 South Korea. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Guideline adherence indicator at 6months (time frame: 6months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04900584, which also lists 1 linked publication.

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 1 Jun 2022.

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