Comparison of BNP and NT-proBNP in the Management of Patients With Chronic and Acute Heart Failure
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable heart-failure
Started Jun 2016
Longer than P75 for not_applicable heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedFirst Posted
Study publicly available on registry
September 27, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedSeptember 27, 2019
September 1, 2019
11 months
August 30, 2016
September 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Out Patient Protocol
Measuring the changes with NT-prooBNP and BNP.
Baseline, 2 weeks, 4 weeks, 6 months, and 12 months
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
Study Arms (1)
one arm
OTHEROne arm study patients where NT-proBNP and BNP tests will be monitored.
Interventions
Effect of Sacubitril/Valsartan on BNP and NT-proBNP
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Unity Health Torontolead
- Alere, Inc.collaborator
Study Sites (1)
St. Michael's Hospital
Toronto, Ontario, M5B1W8, Canada
Related Publications (5)
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.
PMID: 25532421BACKGROUNDMcMurray 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. No abstract available.
PMID: 25494275BACKGROUNDPacker 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, Belohlavek J, Bohm M, Boytsov S, Burgess LJ, Cabrera W, Calvo C, Chen CH, Dukat A, Duarte YC, Erglis A, Fu M, Gomez E, Gonzalez-Medina A, Hagege AA, Huang J, Katova T, Kiatchoosakun S, Kim KS, Kozan O, 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.
PMID: 25403646BACKGROUNDLogeart 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. doi: 10.1016/j.jacc.2003.09.044.
PMID: 14975475BACKGROUNDMaisel 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.
PMID: 18760965BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gordon W Moe, MD, MSc
Unity Health Toronto
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2016
First Posted
September 27, 2019
Study Start
June 1, 2016
Primary Completion
May 1, 2017
Study Completion
June 1, 2020
Last Updated
September 27, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share