NCT04900584

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,009

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 23, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2020

Completed
10 months until next milestone

First Posted

Study publicly available on registry

May 25, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

June 1, 2022

Status Verified

May 1, 2022

Enrollment Period

2.4 years

First QC Date

August 13, 2020

Last Update Submit

May 28, 2022

Conditions

Heart Failure With Reduced Ejection FractionAcute Heart Failure

Keywords

Acute Heart Failure

Outcome Measures

Primary Outcomes (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.

    6months

Secondary Outcomes (11)

  • Guideline adherence indicator at discharge

    0 day (at discharge)

  • Guideline adherence indicator at 1month

    1month after discharge

  • KCCQ(The Kansas City Cardiomyopathy Questionnaire) at discharge

    0 day (at discharge)

  • KCCQ(The Kansas City Cardiomyopathy Questionnaire) at 6 months

    6 months after discharge

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

    0 day (at discharge)

  • +6 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group is managed by applying all three types of intervention.

Other: ChecklistOther: EducationOther: Telephone monitoring

non-Intervention group

NO INTERVENTION

Non-intervention group is managed by conventional heart failure treatment.

Interventions

ChecklistOTHER

Checklist of guideline-based treatment before discharge

Intervention group
EducationOTHER

Heart failure education before discharge

Intervention group
Telephone monitoringOTHER

Telephone monitoring after discharge

Intervention group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wonju Severance Christian Hospital,

Wŏnju, Gangwon-do, 26426, South Korea

Location

MeSH Terms

Interventions

ChecklistEducational Status

Intervention Hierarchy (Ancestors)

Data CollectionHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationSocioeconomic FactorsPopulation Characteristics

Study Officials

  • Byung-Su Yoo, MD, PhD

    Wonju Severance Christian Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2020

First Posted

May 25, 2021

Study Start

June 23, 2020

Primary Completion

October 31, 2022

Study Completion

February 28, 2023

Last Updated

June 1, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)