Comparison of BNP and NT-proBNP in the Management of Patients With Chronic and Acute Heart Failure
Overview
- Phase
- Not Applicable
- Intervention
- Sacubitril/Valsartan
- Conditions
- Heart Failure
- Sponsor
- Unity Health Toronto
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Out Patient Protocol
- Last Updated
- 6 years ago
Overview
Brief Summary
The purpose of this study is to compare the changes in B-type Natriuretic Peptide (BNP) and amino-terminal fragment of proBNP (NT-proBNP) in outpatients managed in the heart failure (HF) clinic initiated on the Angiotensin Receptor Neprilysin Inhibitor (Entresto) and directly compare the prognostic values of BNP and NT-proBNP in patients admitted with acute decompensated HF.
Detailed Description
Both natriuretic peptides (NP), namely B-type NP (BNP) and amino-terminal fragment of proBNP (NT-proBNP), have an established role in the management of patients with heart failure (HF).\[1\] However, the clinical utility of BNP has recently been questioned with the PARADIGM-HF trial, which demonstrated increased BNP and reduced NT-proBNP levels following the administration of Entresto, a newly approved angiotensin receptor neprilysin inhibitor (ARNI).\[2.3\] The increase in BNP was thought to be reflective of reduced metabolism of BNP as a result of neprilysin inhibition.\[2\] However, this claim was based on observations of three points in time and with wide confidence intervals.\[3\] In addition, there has been no attempt to demonstrate dose relationships. Furthermore, although both BNP and NT-proBNP have each been shown to predict HF readmission in hospitalized patients \[1,4,5\] the relative utility between the two NPs for this prediction remains unclear. We therefore hypothesize that once beyond the initiation of ARNI therapy, BNP and NT-proBNP will be equally predictive of clinical events in patients with HF. The studies comprise of two separate protocols: A. Outpatient Protocol - the effect of Entresto measuring the changes in the NT-proBNP and BNP test results. This protocol will be conducted on ambulatory outpatients initiating on Entresto. Patients will have blood sampling for the measurements of BNP and NT-proBNP at baseline, at the first and second up titration in dose of Entresto, and at 6 months and 1st year after starting Entresto. B. Inpatient Protocol-predicting outcomes. This will be conducted on patients admitted for acute decompensated HF. Blood sampling for BNP and NT-proBNP will be collected in different time points (admission, hospital discharge, 30th day, 90th day, and 180th day) and measure its changes.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Out Patient Protocol - Patients with chronic heart failure being followed in the heart failure clinic eligible to switch angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) to ARNI (Entresto).
- •In Patient Protocol - Patients admitted due to acute decompensated heart failure
Exclusion Criteria
- Not provided
Arms & Interventions
one arm
One arm study patients where NT-proBNP and BNP tests will be monitored.
Intervention: Sacubitril/Valsartan
Outcomes
Primary Outcomes
Out Patient Protocol
Time Frame: Baseline, 2 weeks, 4 weeks, 6 months, and 12 months
Measuring the changes with NT-prooBNP and BNP.
In Patient Protocol
Time Frame: Admission, discharge, 30th day post-discharge, 60th day post-discharge, and 180 days post discharge
Measuring the changes with NT-prooBNP and BNP.