Losartan in Decompensated Heart Failure
Short-term add-on Therapy With Angiotensin Receptor Blocker for End-stage Inotrope-dependent Heart Failure Patients: B-type Natriuretic Peptide Reduction in a Randomized Clinical Trial
1 other identifier
interventional
21
1 country
1
Brief Summary
The dual blockade of the renin-angiotensin-aldosterone system with an angiotensin-converting enzyme inhibitor and an angiotensin-receptor blocker used together in heart failure patients has been demonstrated to be beneficial. However, the dual inhibition has not been studied during heart failure decompensation or even when low cardiac output is present. The objective of this study was to assess the effects of add-on therapy with angiotensin receptor blocker on plasma B-type natriuretic peptide levels and hemodynamic measurements in heart failure patients with low cardiac output during hospitalization for decompensation. This was a randomized, double-blind, placebo-controlled clinical trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Sep 2008
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 16, 2013
CompletedFirst Posted
Study publicly available on registry
May 20, 2013
CompletedMay 20, 2013
March 1, 2011
2.4 years
May 16, 2013
May 17, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
B-type natriuretic peptide
Serum B-type natriuretic peptide
7 days
Secondary Outcomes (4)
Successful withdrawal from dobutamine
7 days
Worsening renal function
7 days
Hyperkalemia
7 days
Hypotension
7 days
Study Arms (2)
Losartan
EXPERIMENTALLosartan 50 mg bid orally
Placebo
PLACEBO COMPARATORPlacebo 1 pill bid orally
Interventions
Eligibility Criteria
You may qualify if:
- hospitalization for decompensated heart failure
- dobutamine dependence
- ejection fraction \< 0.45
- taking angiotensin-converting enzyme inhibitor
You may not qualify if:
- serum creatinine \> 3.0 mg/dL
- serum potassium \> 6.0 mEq/L
- systolic blood pressure \< 70 mm Hg
- aortic stenosis
- acute coronary syndrome in the previous 2 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cotoxó Hospital, Heart Institute (InCor), University of São Paulo
São Paulo, São Paulo, 05021-010, Brazil
Related Publications (1)
Ochiai ME, Brancalhao EC, Puig RS, Vieira KR, Cardoso JN, Oliveira MT Jr, Barretto AC. Short-term add-on therapy with angiotensin receptor blocker for end-stage inotrope-dependent heart failure patients: B-type natriuretic peptide reduction in a randomized clinical trial. Clinics (Sao Paulo). 2014;69(5):308-13. doi: 10.6061/clinics/2014(05)02.
PMID: 24838894DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Antonio P Barretto, Ph.D.
Heart Institute (InCor), University of São Paulo
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ph.D.
Study Record Dates
First Submitted
May 16, 2013
First Posted
May 20, 2013
Study Start
September 1, 2008
Primary Completion
February 1, 2011
Study Completion
March 1, 2011
Last Updated
May 20, 2013
Record last verified: 2011-03