Acute Heart Failure, Heart Failure With Reduced Ejection Fraction
Conditions
Keywords
Acute Heart Failure
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.
Interventions
OTHERChecklist
Checklist of guideline-based treatment before discharge
OTHEREducation
Heart failure education before discharge
OTHERTelephone monitoring
Telephone monitoring after discharge
Sponsors
Korean Center for Disease Control and Prevention
Wonju Severance Christian Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| KCCQ(The Kansas City Cardiomyopathy Questionnaire) at discharge | 0 day (at discharge) | the score of the Kansas City Cardiomyopathy Questionnaire |
| KCCQ(The Kansas City Cardiomyopathy Questionnaire) at 6 months | 6 months after 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 |
| All-cause death | up to 6 months | incidence rate (%) of death from any cause |
| Heart failure rehospitalization | up to 6 months | incidence rate (%) of the first rehospitalization due to heart failure |
| Cardiovascular death | up to 6 months | incidence rate (%) of death due to heart failure, arrhythmia and cerebrovascular event. |
| Cardiovascular rehospitalization | up to 6 months | incidence rate (%) of the first rehospitalization 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 |
| EQ-5D(The EuroQoL five-dimensional instrument) at 6 months | 6 months after discharge | the score of The EuroQoL five-dimensional instrument |
Countries
South Korea
Outcome results
None listed