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

Study Overview
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Brief Summary
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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.

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

Conditions
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Heart Failure With Reduced Ejection Fraction, Acute Heart Failure

Intervention / Treatment
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* Other: Checklist
* Other: Education
* Other: Telephone monitoring


Participation Criteria
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Eligibility Criteria
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All consecutive hospitalized adult heart failure patients who fulfill one of 1-3 and satisfy 4-5 simultaneous Inclusion Criteria: 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% Exclusion Criteria: Patients younger than 19 years old Patients who do no consent

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Heart Failure