Back to resultsA Health Economic Evaluation of Using N-Terminal Pro Brain Natriuretic Peptide (NT-Pro BNP) in Acute Heart Failure
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
NT-Pro BNP
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Acute Heart Failure, Cost, NT-pro BNP
Eligibility Criteria
Inclusion Criteria:
- Patients aged 18-75 years
- The primary diagnosis at the Emergency Department (ED) is acute decompensated heart failure (ADHF)
- Using the national health insurance
- Willing to be followed for 3 months
- Willing to sign informed consent.
Exclusion Criteria:
- Severe life-threatening comorbidities with a life expectancy of <2 years
- Acute heart failure other than ADHF such as acute pulmonary edema, acute heart failure in the setting of acute coronary syndrome, cardiogenic shock, right heart failure, and hypertensive heart failure
- ADHF accompanied by sepsis, liver disease, lung disease with severe radiological findings, mechanical complications of acute myocardial infarction, aortic dissection, congenital heart disease, idiopathic pulmonary hypertension, lung emboli, severe respiratory failure, and severe burns
- Patients admitted to ICVCU (Intensive Cardiovascular Care Unit)
- Patients did not take medication regularly and controls routinely.
Sites / Locations
- Heart Failure Biomarker Group
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
NT-pro BNP group
Control group
Arm Description
Subjects who be included in NT-pro BNP group examined NT-pro BNP in the ED to determine the baseline level and prior to discharge for determine the percent decline from baseline level. Patients in the NT-pro BNP group can be discharged if the NT-pro BNP level decreased ≥ 30% from baseline. If the target percent decline is not met, we will do intensification of therapy according to the algorithm
Patients in the control group were managed based on clinical judgment without use of NT-pro BNP testing. In the control group, the decision whether patient can be discharged or not was determined by cardiologist in charge of the patient based on clinical assessment.
Outcomes
Primary Outcome Measures
Mortality rate
Percentage of patients who are death post discharge (%)
Rehospitalization rate
Percentage of patients who readmit and are hospitalized because of heart failure (%)
Emergency department visit
Percentage of patients who readmit and are not hospitalized because of heart failure (%)
Secondary Outcome Measures
Cost
Total cost include cost of hospitalization, cost of rehospitalization and cost of emergency department visit (Rupiah)
Full Information
NCT ID
NCT03669198
First Posted
September 11, 2018
Last Updated
September 12, 2018
Sponsor
Heart Failure Biomarker Group
1. Study Identification
Unique Protocol Identification Number
NCT03669198
Brief Title
A Health Economic Evaluation of Using N-Terminal Pro Brain Natriuretic Peptide (NT-Pro BNP) in Acute Heart Failure
Official Title
A Health Economic Evaluation of Using N-Terminal Pro Brain Natriuretic Peptide (NT-pro BNP) for Management of Acute Heart Failure in a Tertiary Referral Hospital in Jakarta, Indonesia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
February 15, 2018 (Actual)
Study Completion Date
May 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Heart Failure Biomarker Group
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
Cardiac biomarkers have dramatically impacted the way HF patients are evaluated and managed. In fact, the role of biomarkers has developed to better differentiate HF against other diseases and, to timely initiate and influence more accurate diagnosis (rule out) and treatments, to predict the onset of future HF, to risk-stratify affected patients, and to serve as a tool to guide intensity of therapy. NT-proBNP has become validated biomarkers with highest guideline recommendation (class I) and independent predictors for re-hospitalization and mortality in HF patients. However, many Indonesian cardiologists do not use of those biomarkers, mostly due to limited available cardiac biomarkers for the cost effective heart failure management. We evaluate 2 alternative treatments which one that more cost-effective between biomarker's guided therapy and without biomarker.
Detailed Description
With growing demands on limited health care budgets, optimal resource allocation in HF patients is essential. Although NT pro BNP is proposed to be effective for the evaluation and management patients with heart failure, no data exist about cost-effectiveness analysis that are based on practice patterns endorsed by universal coverage systems in Indonesia (Jaminan Kesehatan Nasional). Because NT-proBNP therapy guidance in HF is believed to create additional costs, it is not yet broadly applicable. Its why we need to elaborate this issue.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Acute Heart Failure, Cost, NT-pro BNP
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NT-pro BNP group
Arm Type
Active Comparator
Arm Description
Subjects who be included in NT-pro BNP group examined NT-pro BNP in the ED to determine the baseline level and prior to discharge for determine the percent decline from baseline level. Patients in the NT-pro BNP group can be discharged if the NT-pro BNP level decreased ≥ 30% from baseline. If the target percent decline is not met, we will do intensification of therapy according to the algorithm
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients in the control group were managed based on clinical judgment without use of NT-pro BNP testing. In the control group, the decision whether patient can be discharged or not was determined by cardiologist in charge of the patient based on clinical assessment.
Intervention Type
Diagnostic Test
Intervention Name(s)
NT-Pro BNP
Other Intervention Name(s)
Natriuretic peptide
Intervention Description
. AHF patients who met inclusion and exclusion criteria were randomly assigned to 2 groups, NT-pro BNP group and control group. In the NT-pro BNP group, serial NT-pro BNP levels at admission and pre-discharge was measured, the latter with the target of decrease ≥ 30% NT-pro BNP level. Randomised patients were followed during treatment up to 90 days post-discharge to assess short-term outcomes and costs.
Primary Outcome Measure Information:
Title
Mortality rate
Description
Percentage of patients who are death post discharge (%)
Time Frame
3 months after discharge
Title
Rehospitalization rate
Description
Percentage of patients who readmit and are hospitalized because of heart failure (%)
Time Frame
3 months after discharge
Title
Emergency department visit
Description
Percentage of patients who readmit and are not hospitalized because of heart failure (%)
Time Frame
3 months after discharge
Secondary Outcome Measure Information:
Title
Cost
Description
Total cost include cost of hospitalization, cost of rehospitalization and cost of emergency department visit (Rupiah)
Time Frame
Admission to hospital until 3 months after discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged 18-75 years
The primary diagnosis at the Emergency Department (ED) is acute decompensated heart failure (ADHF)
Using the national health insurance
Willing to be followed for 3 months
Willing to sign informed consent.
Exclusion Criteria:
Severe life-threatening comorbidities with a life expectancy of <2 years
Acute heart failure other than ADHF such as acute pulmonary edema, acute heart failure in the setting of acute coronary syndrome, cardiogenic shock, right heart failure, and hypertensive heart failure
ADHF accompanied by sepsis, liver disease, lung disease with severe radiological findings, mechanical complications of acute myocardial infarction, aortic dissection, congenital heart disease, idiopathic pulmonary hypertension, lung emboli, severe respiratory failure, and severe burns
Patients admitted to ICVCU (Intensive Cardiovascular Care Unit)
Patients did not take medication regularly and controls routinely.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prima Almazini, MD
Organizational Affiliation
Heart Failure Biomarker Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart Failure Biomarker Group
City
Jakarta
State/Province
DKI Jakarta
ZIP/Postal Code
10420
Country
Indonesia
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IPD are not to be shared with other researchers
Learn more about this trial
A Health Economic Evaluation of Using N-Terminal Pro Brain Natriuretic Peptide (NT-Pro BNP) in Acute Heart Failure
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