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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,009
Checklist of guideline-based treatment before discharge
Heart failure education before discharge
Telephone monitoring after discharge
Wonju Severance Christian Hospital,
Wŏnju, Gangwon-do, South Korea
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.
Time frame: 6months
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.
Time frame: 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.
Time frame: 1month after discharge
KCCQ(The Kansas City Cardiomyopathy Questionnaire) at discharge
the score of the Kansas City Cardiomyopathy Questionnaire
Time frame: 0 day (at discharge)
KCCQ(The Kansas City Cardiomyopathy Questionnaire) at 6 months
the score of the Kansas City Cardiomyopathy Questionnaire
Time frame: 6 months after discharge
EQ-5D(The EuroQoL five-dimensional instrument) at discharge
the score of the EuroQoL five-dimensional instrument
Time frame: 0 day (at discharge)
EQ-5D(The EuroQoL five-dimensional instrument) at 6 months
the score of The EuroQoL five-dimensional instrument
Time frame: 6 months after discharge
All-cause death
incidence rate (%) of death from any cause
Time frame: up to 6 months
Heart failure rehospitalization
incidence rate (%) of the first rehospitalization due to heart failure
Time frame: up to 6 months
Cardiovascular death
incidence rate (%) of death due to heart failure, arrhythmia and cerebrovascular event.
Time frame: up to 6 months
Cardiovascular rehospitalization
incidence rate (%) of the first rehospitalization due to heart failure, arrhythmia, and cerebrovascular event.
Time frame: up to 6 months
Composite end-point
incidence rate (%) of all-cause death and the first rehospitalization rehospitalization
Time frame: up to 6 months
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