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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Diagnostic test: NT-Pro BNP

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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta, DKI Jakarta, Indonesia, 10420
      • Heart Failure Biomarker Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: NT-pro BNP group; 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	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.; Other Names: Natriuretic peptide
NO_INTERVENTION: Control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality rate	Percentage of patients who are death post discharge (%)	3 months after discharge
Rehospitalization rate	Percentage of patients who readmit and are hospitalized because of heart failure (%)	3 months after discharge
Emergency department visit	Percentage of patients who readmit and are not hospitalized because of heart failure (%)	3 months after discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Heart Failure Biomarker Group
• Investigators: Principal Investigator: Prima Almazini, MD, Heart Failure Biomarker Group

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2017
• Primary Completion (ACTUAL): February 15, 2018
• Study Completion (ACTUAL): May 31, 2018

Study Registration Dates

• First Submitted: September 11, 2018
• First Submitted That Met QC Criteria: September 12, 2018
• First Posted (ACTUAL): September 13, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 13, 2018
• Last Update Submitted That Met QC Criteria: September 12, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Cost; Acute Heart Failure; NT-pro BNP
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: HFBG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD are not to be shared with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No