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

NCT03669198 | Completed DMC

• 1 other identifier: HFBG
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Acute Heart Failure; Cost; NT-pro BNP

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Cost

  Admission to hospital until 3 months after discharge

Study Arms (2)

NT-pro BNP group

ACTIVE COMPARATOR

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

Control group

NO INTERVENTION

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.

Interventions

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.

Also known as: Natriuretic peptide

NT-pro BNP group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heart Failure Biomarker Group: lead

Study Sites (1)

Heart Failure Biomarker Group

Jakarta, DKI Jakarta, 10420, Indonesia

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Prima Almazini, MD

  Heart Failure Biomarker Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: September 13, 2018
• Study Start: November 1, 2017
• Primary Completion: February 15, 2018
• Study Completion: May 31, 2018
• Last Updated: September 13, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)