Clinical trial NCT03669198: 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
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Acute Heart Failure
Cost
NT-pro BNP
Lead sponsor: Heart Failure Biomarker Group
Sponsor class: INDIV
First posted: 2018-09-13
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Mortality rate
timeFrame: 3 months after discharge
measure: Rehospitalization rate
timeFrame: 3 months after discharge
measure: Emergency department visit
timeFrame: 3 months after discharge
Secondary outcomes:
measure: Cost
timeFrame: Admission to hospital until 3 months after discharge
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Heart Failure Biomarker Group
state: DKI Jakarta
Study officials:
affiliation: Heart Failure Biomarker Group
name: Prima Almazini, MD
role: PRINCIPAL_INVESTIGATOR
References: