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Completed

NCT Number: NCT03669198

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heart Failure Biomarker Group

Jakarta, DKI Jakarta, 10420, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NT-Pro BNP

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.

Other names: Natriuretic peptide

Primary outcomes

  1. Mortality rate

    Time frame: 3 months after discharge

    Percentage of patients who are death post discharge (%)

  2. Rehospitalization rate

    Time frame: 3 months after discharge

    Percentage of patients who readmit and are hospitalized because of heart failure (%)

  3. Emergency department visit

    Time frame: 3 months after discharge

    Percentage of patients who readmit and are not hospitalized because of heart failure (%)

Secondary outcomes

  1. Cost

    Time frame: Admission to hospital until 3 months after discharge

    Total cost include cost of hospitalization, cost of rehospitalization and cost of emergency department visit (Rupiah)

Sponsors and collaborators

Lead sponsor

Heart Failure Biomarker Group

Indiv

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 13, 2018
Registry last updated
Sep 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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