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Clinical Trials/NCT03669198
NCT03669198
Completed
Not Applicable

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

Heart Failure Biomarker Group1 site in 1 country56 target enrollmentNovember 1, 2017
ConditionsHeart Failure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Heart Failure Biomarker Group
Enrollment
56
Locations
1
Primary Endpoint
Mortality rate
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2017
End Date
May 31, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Heart Failure Biomarker Group
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Mortality rate

Time Frame: 3 months after discharge

Percentage of patients who are death post discharge (%)

Rehospitalization rate

Time Frame: 3 months after discharge

Percentage of patients who readmit and are hospitalized because of heart failure (%)

Emergency department visit

Time Frame: 3 months after discharge

Percentage of patients who readmit and are not hospitalized because of heart failure (%)

Secondary Outcomes

  • Cost(Admission to hospital until 3 months after discharge)

Study Sites (1)

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