Clinical trial NCT04900584: Optimize Heart Failure Care During TRANSitional Period in Patients With Acute Heart Failure.
Official title: A Prospective Randomized Multicenter Controlled Study to Optimize Heart Failure Care During TRANSitional Period in Patients With Acute Heart Failure With Reduced Ejection Fraction.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure With Reduced Ejection Fraction
Acute Heart Failure
Keywords: Acute Heart Failure
Lead sponsor: Wonju Severance Christian Hospital
Sponsor class: OTHER
Collaborators: name: Korean Center for Disease Control and Prevention
First posted: 2021-05-25
Enrollment: 1009
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Guideline adherence indicator at 6months
timeFrame: 6months
Secondary outcomes:
measure: Guideline adherence indicator at discharge
timeFrame: 0 day (at discharge)
measure: Guideline adherence indicator at 1month
timeFrame: 1month after discharge
measure: KCCQ(The Kansas City Cardiomyopathy Questionnaire) at discharge
timeFrame: 0 day (at discharge)
measure: KCCQ(The Kansas City Cardiomyopathy Questionnaire) at 6 months
timeFrame: 6 months after discharge
measure: EQ-5D(The EuroQoL five-dimensional instrument) at discharge
timeFrame: 0 day (at discharge)
measure: EQ-5D(The EuroQoL five-dimensional instrument) at 6 months
timeFrame: 6 months after discharge
measure: All-cause death
timeFrame: up to 6 months
measure: Heart failure rehospitalization
timeFrame: up to 6 months
measure: Cardiovascular death
timeFrame: up to 6 months
measure: Cardiovascular rehospitalization
timeFrame: up to 6 months
measure: Composite end-point
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital,
state: Gangwon-do
Study officials:
affiliation: Wonju Severance Christian Hospital
name: Byung-Su Yoo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: