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

Heart Failure With Reduced Ejection Fraction Clinical Trial

— TRANS-HF  

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04900584
• Other study ID #: 2019ER630301
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 23, 2020
• Est. completion date: February 28, 2023

Study information

• Verified date: May 2022
• Source: Wonju Severance Christian Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1009
• Est. completion date: February 28, 2023
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Heart Failure
• Heart Failure
• Heart Failure With Reduced Ejection Fraction

Intervention

Other:
• Checklist
Checklist of guideline-based treatment before discharge
• Education
Heart failure education before discharge
• Telephone monitoring
Telephone monitoring after discharge

Locations

Country	Name	City	State
Korea, Republic of	Wonju Severance Christian Hospital,	Wonju	Gangwon-do

Sponsors (2)

Lead Sponsor	Collaborator
Wonju Severance Christian Hospital	Korean Center for Disease Control and Prevention

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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
Secondary	KCCQ(The Kansas City Cardiomyopathy Questionnaire) at discharge	the score of the Kansas City Cardiomyopathy Questionnaire	0 day (at discharge)
Secondary	KCCQ(The Kansas City Cardiomyopathy Questionnaire) at 6 months	the score of the Kansas City Cardiomyopathy Questionnaire	6 months after discharge
Secondary	EQ-5D(The EuroQoL five-dimensional instrument) at discharge	the score of the EuroQoL five-dimensional instrument	0 day (at discharge)
Secondary	EQ-5D(The EuroQoL five-dimensional instrument) at 6 months	the score of The EuroQoL five-dimensional instrument	6 months after discharge
Secondary	All-cause death	incidence rate (%) of death from any cause	up to 6 months
Secondary	Heart failure rehospitalization	incidence rate (%) of the first rehospitalization due to heart failure	up to 6 months
Secondary	Cardiovascular death	incidence rate (%) of death due to heart failure, arrhythmia and cerebrovascular event.	up to 6 months
Secondary	Cardiovascular rehospitalization	incidence rate (%) of the first rehospitalization due to heart failure, arrhythmia, and cerebrovascular event.	up to 6 months
Secondary	Composite end-point	incidence rate (%) of all-cause death and the first rehospitalization rehospitalization	up to 6 months