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A Health Economic Evaluation of Using N-Terminal Pro Brain Natriuretic Peptide (NT-Pro BNP) in Acute Heart Failure

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03669198
Enrollment
56
Registered
2018-09-13
Start date
2017-11-01
Completion date
2018-05-31
Last updated
2018-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Acute Heart Failure, Cost, NT-pro BNP

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.

Interventions

DIAGNOSTIC_TESTNT-Pro BNP

. 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.

Sponsors

Heart Failure Biomarker Group
Lead SponsorINDIV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Mortality rate3 months after dischargePercentage of patients who are death post discharge (%)
Rehospitalization rate3 months after dischargePercentage of patients who readmit and are hospitalized because of heart failure (%)
Emergency department visit3 months after dischargePercentage of patients who readmit and are not hospitalized because of heart failure (%)

Secondary

MeasureTime frameDescription
CostAdmission to hospital until 3 months after dischargeTotal cost include cost of hospitalization, cost of rehospitalization and cost of emergency department visit (Rupiah)

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026