Optimize Heart Failure Care During TRANSitional Period in Patients With Acute Heart Failure. (TRANS-HF)
Primary Purpose
Heart Failure With Reduced Ejection Fraction, Acute Heart Failure
Status
Active
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Checklist
Education
Telephone monitoring
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure With Reduced Ejection Fraction focused on measuring Acute Heart Failure
Eligibility Criteria
All consecutive hospitalized adult heart failure patients who fulfill one of 1-3 and satisfy 4-5 simultaneous
Inclusion Criteria:
- 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%
Exclusion Criteria:
- Patients younger than 19 years old
- Patients who do no consent
Sites / Locations
- Wonju Severance Christian Hospital,
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
non-Intervention group
Arm Description
The intervention group is managed by applying all three types of intervention.
Non-intervention group is managed by conventional heart failure treatment.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
KCCQ(The Kansas City Cardiomyopathy Questionnaire) at discharge
the score of the Kansas City Cardiomyopathy Questionnaire
KCCQ(The Kansas City Cardiomyopathy Questionnaire) at 6 months
the score of the Kansas City Cardiomyopathy Questionnaire
EQ-5D(The EuroQoL five-dimensional instrument) at discharge
the score of the EuroQoL five-dimensional instrument
EQ-5D(The EuroQoL five-dimensional instrument) at 6 months
the score of The EuroQoL five-dimensional instrument
All-cause death
incidence rate (%) of death from any cause
Heart failure rehospitalization
incidence rate (%) of the first rehospitalization due to heart failure
Cardiovascular death
incidence rate (%) of death due to heart failure, arrhythmia and cerebrovascular event.
Cardiovascular rehospitalization
incidence rate (%) of the first rehospitalization due to heart failure, arrhythmia, and cerebrovascular event.
Composite end-point
incidence rate (%) of all-cause death and the first rehospitalization rehospitalization
Full Information
NCT ID
NCT04900584
First Posted
August 13, 2020
Last Updated
May 28, 2022
Sponsor
Wonju Severance Christian Hospital
Collaborators
Korean Center for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT04900584
Brief Title
Optimize Heart Failure Care During TRANSitional Period in Patients With Acute Heart Failure.
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 23, 2020 (Actual)
Primary Completion Date
October 31, 2022 (Anticipated)
Study Completion Date
February 28, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wonju Severance Christian Hospital
Collaborators
Korean Center for Disease Control and Prevention
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Reduced Ejection Fraction, Acute Heart Failure
Keywords
Acute Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1009 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
The intervention group is managed by applying all three types of intervention.
Arm Title
non-Intervention group
Arm Type
No Intervention
Arm Description
Non-intervention group is managed by conventional heart failure treatment.
Intervention Type
Other
Intervention Name(s)
Checklist
Intervention Description
Checklist of guideline-based treatment before discharge
Intervention Type
Other
Intervention Name(s)
Education
Intervention Description
Heart failure education before discharge
Intervention Type
Other
Intervention Name(s)
Telephone monitoring
Intervention Description
Telephone monitoring after discharge
Primary Outcome Measure Information:
Title
Guideline adherence indicator at 6months
Description
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
Secondary Outcome Measure Information:
Title
Guideline adherence indicator at discharge
Description
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)
Title
Guideline adherence indicator at 1month
Description
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
Title
KCCQ(The Kansas City Cardiomyopathy Questionnaire) at discharge
Description
the score of the Kansas City Cardiomyopathy Questionnaire
Time Frame
0 day (at discharge)
Title
KCCQ(The Kansas City Cardiomyopathy Questionnaire) at 6 months
Description
the score of the Kansas City Cardiomyopathy Questionnaire
Time Frame
6 months after discharge
Title
EQ-5D(The EuroQoL five-dimensional instrument) at discharge
Description
the score of the EuroQoL five-dimensional instrument
Time Frame
0 day (at discharge)
Title
EQ-5D(The EuroQoL five-dimensional instrument) at 6 months
Description
the score of The EuroQoL five-dimensional instrument
Time Frame
6 months after discharge
Title
All-cause death
Description
incidence rate (%) of death from any cause
Time Frame
up to 6 months
Title
Heart failure rehospitalization
Description
incidence rate (%) of the first rehospitalization due to heart failure
Time Frame
up to 6 months
Title
Cardiovascular death
Description
incidence rate (%) of death due to heart failure, arrhythmia and cerebrovascular event.
Time Frame
up to 6 months
Title
Cardiovascular rehospitalization
Description
incidence rate (%) of the first rehospitalization due to heart failure, arrhythmia, and cerebrovascular event.
Time Frame
up to 6 months
Title
Composite end-point
Description
incidence rate (%) of all-cause death and the first rehospitalization rehospitalization
Time Frame
up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
All consecutive hospitalized adult heart failure patients who fulfill one of 1-3 and satisfy 4-5 simultaneous
Inclusion Criteria:
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%
Exclusion Criteria:
Patients younger than 19 years old
Patients who do no consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Byung-Su Yoo, MD, PhD
Organizational Affiliation
Wonju Severance Christian Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wonju Severance Christian Hospital,
City
Wonju
State/Province
Gangwon-do
ZIP/Postal Code
26426
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
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Optimize Heart Failure Care During TRANSitional Period in Patients With Acute Heart Failure.
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