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

Not Applicable

• Conditions: Acute Heart Failure; Heart Failure With Reduced Ejection Fraction

• Registration Number: NCT04900584
• Lead Sponsor: Wonju Severance Christian Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-23
• Study First Submitted: 2020-08-13
• Study First Submitted QC: 2021-05-24
• Study First Posted: 2021-05-25
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-28
• Last Update Posted: 2022-06-01
• Primary Completion: 2022-10-31
• Study Completion: 2023-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1009

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Guideline adherence indicator at 6months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Wonju Severance Christian Hospital,; 🇰🇷 Wonju, Gangwon-do, Korea, Republic of