NCT03669198|CompletedDMC
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Sponsor study identifier
interventional
56
1 country
1
Study Start
November 1, 2017
Actual (reported)Primary Completion
February 15, 2018
Actual (reported)Study Completion
May 31, 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 31, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 1, 2017
Actual (reported)February 15, 2018
Actual (reported)May 31, 2018
Actual (reported)September 11, 2018
Actual (reported)September 13, 2018
Actual (reported)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
Cost
Admission to hospital until 3 months after discharge
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
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Heart Failure Biomarker Group
Jakarta, DKI Jakarta, 10420, Indonesia
Prima Almazini, MD
Heart Failure Biomarker Group
56 participants (actual enrollment reported by the registry).
First Submitted
September 11, 2018
First Posted
September 13, 2018
Study Start
November 1, 2017
Actual (reported)Protocol of a Pilot Study to Optimize Care for Heart Failure Patients in Primary Care
Contact the study team to confirm eligibility.
Primary Completion
February 15, 2018
Actual (reported)Study Completion
May 31, 2018
Actual (reported)Last Updated
September 13, 2018
Record last verified: 2018-09
IPD are not to be shared with other researchers
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Source: ClinicalTrials.gov.
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