An interventional study of Sacubitril/Valsartan in Heart Failure, sponsored by Unity Health Toronto. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-27.
Sponsored by Unity Health Toronto · Not applicable, Interventional, and Treatment
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.
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.
5,701 studies on the registry are indexed under Heart Failure; 1,219 are open to participants now.
This study's planned enrollment of 300 is above the median of 72 across 3,733 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Unity Health Toronto is the lead sponsor of 434 studies on the registry; 76 are open to participants now.
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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
One arm study patients where NT-proBNP and BNP tests will be monitored.
Drug: Sacubitril/Valsartan
Effect of Sacubitril/Valsartan on BNP and NT-proBNP
Also known as: Entresto
Out Patient Protocol
Measuring the changes with NT-prooBNP and BNP.
Time frame: Baseline, 2 weeks, 4 weeks, 6 months, and 12 months
In Patient Protocol
Measuring the changes with NT-prooBNP and BNP.
Time frame: Admission, discharge, 30th day post-discharge, 60th day post-discharge, and 180 days post discharge
Plan to share: No
This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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