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

NCT ID: NCT03669198

Last Updated: 2018-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2018-05-31

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

NT-Pro BNP

Intervention Type: DIAGNOSTIC_TEST

. 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Natriuretic peptide

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heart Failure Biomarker Group

INDIV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prima Almazini, MD

Role: PRINCIPAL_INVESTIGATOR

Heart Failure Biomarker Group

Locations

Heart Failure Biomarker Group

Jakarta, DKI Jakarta, Indonesia

Countries

Indonesia

Other Identifiers

HFBG

Identifier Type: -

Identifier Source: org_study_id