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

Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03669198
• Other study ID #: HFBG
• Status: Completed
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: May 31, 2018

Study information

• Verified date: September 2018
• Source: Heart Failure Biomarker Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: May 31, 2018
• Est. primary completion date: February 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Diagnostic Test:
• NT-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.

Locations

Country	Name	City	State
Indonesia	Heart Failure Biomarker Group	Jakarta	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Heart Failure Biomarker Group

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality rate	Percentage of patients who are death post discharge (%)	3 months after discharge
Primary	Rehospitalization rate	Percentage of patients who readmit and are hospitalized because of heart failure (%)	3 months after discharge
Primary	Emergency department visit	Percentage of patients who readmit and are not hospitalized because of heart failure (%)	3 months after discharge
Secondary	Cost	Total cost include cost of hospitalization, cost of rehospitalization and cost of emergency department visit (Rupiah)	Admission to hospital until 3 months after discharge