Optimize Heart Failure Care During TRANSitional Period in Patients With Acute Heart Failure.
- Conditions
- Acute Heart FailureHeart Failure With Reduced Ejection Fraction
- Interventions
- Other: ChecklistOther: EducationOther: Telephone monitoring
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1009
- 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%
- Patients younger than 19 years old
- Patients who do no consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group Education The intervention group is managed by applying all three types of intervention. Intervention group Telephone monitoring The intervention group is managed by applying all three types of intervention. Intervention group Checklist The intervention group is managed by applying all three types of intervention.
- 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
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.
All-cause death up to 6 months incidence rate (%) of death from any cause
Trial Locations
- Locations (1)
Wonju Severance Christian Hospital,
🇰🇷Wonju, Gangwon-do, Korea, Republic of