Optimize Heart Failure Care During TRANSitional Period in Patients With Acute Heart Failure. (TRANS-HF)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Failure With Reduced Ejection Fraction; Acute Heart Failure
• Intervention / Treatment: Other: Checklist; Other: Education; Other: Telephone monitoring

• Study Type: Interventional
• Enrollment (Actual): 1009
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gangwon-do
    • Wonju, Gangwon-do, Korea, Republic of, 26426
      • Wonju Severance Christian Hospital,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

All consecutive hospitalized adult heart failure patients who fulfill one of 1-3 and satisfy 4-5 simultaneous

Inclusion Criteria:

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

Exclusion Criteria:

1. Patients younger than 19 years old
2. Patients who do no consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; The intervention group is managed by applying all three types of intervention.	Other: Checklist; Checklist of guideline-based treatment before discharge; Other: Education; Heart failure education before discharge; Other: Telephone monitoring; Telephone monitoring after discharge
No Intervention: non-Intervention group; Non-intervention group is managed by conventional heart failure treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	0 day (at discharge)
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.	1month after discharge
KCCQ(The Kansas City Cardiomyopathy Questionnaire) at discharge	the score of the Kansas City Cardiomyopathy Questionnaire	0 day (at discharge)
KCCQ(The Kansas City Cardiomyopathy Questionnaire) at 6 months	the score of the Kansas City Cardiomyopathy Questionnaire	6 months after discharge
EQ-5D(The EuroQoL five-dimensional instrument) at discharge	the score of the EuroQoL five-dimensional instrument	0 day (at discharge)
EQ-5D(The EuroQoL five-dimensional instrument) at 6 months	the score of The EuroQoL five-dimensional instrument	6 months after discharge
All-cause death	incidence rate (%) of death from any cause	up to 6 months
Heart failure rehospitalization	incidence rate (%) of the first rehospitalization due to heart failure	up to 6 months
Cardiovascular death	incidence rate (%) of death due to heart failure, arrhythmia and cerebrovascular event.	up to 6 months
Cardiovascular rehospitalization	incidence rate (%) of the first rehospitalization due to heart failure, arrhythmia, and cerebrovascular event.	up to 6 months
Composite end-point	incidence rate (%) of all-cause death and the first rehospitalization rehospitalization	up to 6 months

Collaborators and Investigators

• Sponsor: Wonju Severance Christian Hospital
• Collaborators: Korean Center for Disease Control and Prevention
• Investigators: Principal Investigator: Byung-Su Yoo, MD, PhD, Wonju Severance Christian Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2020
• Primary Completion (Anticipated): October 31, 2022
• Study Completion (Anticipated): February 28, 2023

Study Registration Dates

• First Submitted: August 13, 2020
• First Submitted That Met QC Criteria: May 24, 2021
• First Posted (Actual): May 25, 2021

Study Record Updates

• Last Update Posted (Actual): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 28, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Acute Heart Failure
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 2019ER630301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No