An interventional study of NT-Pro BNP in Heart Failure, sponsored by Heart Failure Biomarker Group. Completed at 1 site in Indonesia. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-09-13.
Sponsored by Heart Failure Biomarker Group · Not applicable, Interventional, and Treatment
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.
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 56 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →This is the only study on the registry with Heart Failure Biomarker Group as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
. 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
Mortality rate
Percentage of patients who are death post discharge (%)
Time frame: 3 months after discharge
Rehospitalization rate
Percentage of patients who readmit and are hospitalized because of heart failure (%)
Time frame: 3 months after discharge
Emergency department visit
Percentage of patients who readmit and are not hospitalized because of heart failure (%)
Time frame: 3 months after discharge
Cost
Total cost include cost of hospitalization, cost of rehospitalization and cost of emergency department visit (Rupiah)
Time frame: Admission to hospital until 3 months after discharge
Plan to share: No — IPD are not to be shared with other researchers
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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