Comparison of BNP and NT-proBNP in the Management of Patients With Chronic and Acute Heart Failure

Heart Failure Clinical Trial

Official title:

Comparison of BNP and NT-proBNP in the Management of Patients With Chronic and Acute Heart Failure

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04107220
• Other study ID #: CAN0014
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2016
• Est. completion date: June 2020

Study information

• Verified date: September 2019
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: June 2020
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• Sacubitril/Valsartan
Effect of Sacubitril/Valsartan on BNP and NT-proBNP

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto	Alere, Inc.

Country where clinical trial is conducted

Canada, 

References & Publications (5)

Logeart D, Thabut G, Jourdain P, Chavelas C, Beyne P, Beauvais F, Bouvier E, Solal AC. Predischarge B-type natriuretic peptide assay for identifying patients at high risk of re-admission after decompensated heart failure. J Am Coll Cardiol. 2004 Feb 18;43(4):635-41. — View Citation

Maisel A, Mueller C, Adams K Jr, Anker SD, Aspromonte N, Cleland JG, Cohen-Solal A, Dahlstrom U, DeMaria A, Di Somma S, Filippatos GS, Fonarow GC, Jourdain P, Komajda M, Liu PP, McDonagh T, McDonald K, Mebazaa A, Nieminen MS, Peacock WF, Tubaro M, Valle R, Vanderhyden M, Yancy CW, Zannad F, Braunwald E. State of the art: using natriuretic peptide levels in clinical practice. Eur J Heart Fail. 2008 Sep;10(9):824-39. doi: 10.1016/j.ejheart.2008.07.014. Epub 2008 Aug 29. Review. — View Citation

McMurray JJ, Packer M, Solomon SD. Neprilysin inhibition for heart failure. N Engl J Med. 2014 Dec 11;371(24):2336-7. doi: 10.1056/NEJMc1412654. — View Citation

Moe GW, Ezekowitz JA, O'Meara E, Lepage S, Howlett JG, Fremes S, Al-Hesayen A, Heckman GA, Abrams H, Ducharme A, Estrella-Holder E, Grzeslo A, Harkness K, Koshman SL, McDonald M, McKelvie R, Rajda M, Rao V, Swiggum E, Virani S, Zieroth S, Arnold JM, Ashton T, D'Astous M, Chan M, De S, Dorian P, Giannetti N, Haddad H, Isaac DL, Kouz S, Leblanc MH, Liu P, Ross HJ, Sussex B, White M; Canadian Cardiovascular Society. The 2014 Canadian Cardiovascular Society Heart Failure Management Guidelines Focus Update: anemia, biomarkers, and recent therapeutic trial implications. Can J Cardiol. 2015 Jan;31(1):3-16. doi: 10.1016/j.cjca.2014.10.022. Epub 2014 Dec 19. Erratum in: Can J Cardiol. 2016 Mar;32(3):394. — View Citation

Packer M, McMurray JJ, Desai AS, Gong J, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Solomon SD, Swedberg K, Zile M, Andersen K, Arango JL, Arnold JM, Belohlávek J, Böhm M, Boytsov S, Burgess LJ, Cabrera W, Calvo C, Chen CH, Dukat A, Duarte YC, Erglis A, Fu M, Gomez E, Gonzàlez-Medina A, Hagège AA, Huang J, Katova T, Kiatchoosakun S, Kim KS, Kozan Ö, Llamas EB, Martinez F, Merkely B, Mendoza I, Mosterd A, Negrusz-Kawecka M, Peuhkurinen K, Ramires FJ, Refsgaard J, Rosenthal A, Senni M, Sibulo AS Jr, Silva-Cardoso J, Squire IB, Starling RC, Teerlink JR, Vanhaecke J, Vinereanu D, Wong RC; PARADIGM-HF Investigators and Coordinators. Angiotensin receptor neprilysin inhibition compared with enalapril on the risk of clinical progression in surviving patients with heart failure. Circulation. 2015 Jan 6;131(1):54-61. doi: 10.1161/CIRCULATIONAHA.114.013748. Epub 2014 Nov 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Out Patient Protocol	Measuring the changes with NT-prooBNP and BNP.	Baseline, 2 weeks, 4 weeks, 6 months, and 12 months
Primary	In Patient Protocol	Measuring the changes with NT-prooBNP and BNP.	Admission, discharge, 30th day post-discharge, 60th day post-discharge, and 180 days post discharge