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

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ClinicalTrials.gov Identifier: NCT03669198
Recruitment Status : Completed
First Posted : September 13, 2018
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
Heart Failure Biomarker Group

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.

Condition or disease Intervention/treatment Phase
Heart Failure Diagnostic Test: NT-Pro BNP Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : November 1, 2017
Actual Primary Completion Date : February 15, 2018
Actual Study Completion Date : May 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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 Name: 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.



Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03669198


Locations
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Indonesia
Heart Failure Biomarker Group
Jakarta, DKI Jakarta, Indonesia, 10420
Sponsors and Collaborators
Heart Failure Biomarker Group
Investigators
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Principal Investigator: Prima Almazini, MD Heart Failure Biomarker Group

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Responsible Party: Heart Failure Biomarker Group
ClinicalTrials.gov Identifier: NCT03669198     History of Changes
Other Study ID Numbers: HFBG
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD are not to be shared with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Heart Failure Biomarker Group:
Acute Heart Failure
Cost
NT-pro BNP

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Natriuretic Peptide, Brain
Natriuretic Agents
Physiological Effects of Drugs