Losartan in Decompensated Heart Failure
Primary Purpose
Congestive Heart Failure, Low Cardiac Output
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Losartan
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Congestive Heart Failure focused on measuring Renin-aldosterone system, Hemodynamic, Low cardiac output, Vasodilation, Natriuretic peptide
Eligibility Criteria
Inclusion Criteria:
- hospitalization for decompensated heart failure
- dobutamine dependence
- ejection fraction < 0.45
- taking angiotensin-converting enzyme inhibitor
Exclusion Criteria:
- 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
Sites / Locations
- Cotoxó Hospital, Heart Institute (InCor), University of São Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Losartan
Placebo
Arm Description
Losartan 50 mg bid orally
Placebo 1 pill bid orally
Outcomes
Primary Outcome Measures
B-type natriuretic peptide
Serum B-type natriuretic peptide
Secondary Outcome Measures
Successful withdrawal from dobutamine
Successful withdrawal from dobutamine with clinical stability
Worsening renal function
Increase > 0.3 mg/dL in serum creatinine
Hyperkalemia
Serum potassium > 5.5 mEq/L
Hypotension
Systolic blood pressure < 80 mmHg
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01857999
Brief Title
Losartan in Decompensated Heart Failure
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
InCor Heart Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
The inclusion criteria were hospitalization for decompensated heart failure defined by worsening of symptoms until fatigue or dyspnea at rest, low cardiac output defined by the clinical-hemodynamic profile, dobutamine dependence, and ejection fraction < 0.45, spontaneous breathing and receiving angiotensin-converting enzyme inhibitors. The patients could have jugular ingurgitation, lower limbs edema, ascites and rales. Dobutamine dependence was defined by infusion for more than 15 days or an unsuccessful attempt of withdrawal.
The exclusion criteria were serum creatinine > 3.0 mg/dL, serum potassium > 6.0 mEq/L, systolic blood pressure < 70 mm Hg, aortic stenosis, and acute coronary syndrome in the previous 2 months. The patients were randomly assigned by permuted block of 4, stratified by sex, to losartan or placebo.
The endpoints were change in B-type natriuretic peptide levels, cardiac index, pulmonary wedge capillary pressure, systemic vascular resistance, and successful withdrawal of dobutamine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure, Low Cardiac Output
Keywords
Renin-aldosterone system, Hemodynamic, Low cardiac output, Vasodilation, Natriuretic peptide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Losartan
Arm Type
Experimental
Arm Description
Losartan 50 mg bid orally
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 1 pill bid orally
Intervention Type
Drug
Intervention Name(s)
Losartan
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
B-type natriuretic peptide
Description
Serum B-type natriuretic peptide
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Successful withdrawal from dobutamine
Description
Successful withdrawal from dobutamine with clinical stability
Time Frame
7 days
Title
Worsening renal function
Description
Increase > 0.3 mg/dL in serum creatinine
Time Frame
7 days
Title
Hyperkalemia
Description
Serum potassium > 5.5 mEq/L
Time Frame
7 days
Title
Hypotension
Description
Systolic blood pressure < 80 mmHg
Time Frame
7 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
hospitalization for decompensated heart failure
dobutamine dependence
ejection fraction < 0.45
taking angiotensin-converting enzyme inhibitor
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio P Barretto, Ph.D.
Organizational Affiliation
Heart Institute (InCor), University of São Paulo
Official's Role
Study Director
Facility Information:
Facility Name
Cotoxó Hospital, Heart Institute (InCor), University of São Paulo
City
São Paulo
State/Province
SP
ZIP/Postal Code
05021-010
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
24838894
Citation
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.
Results Reference
derived
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Losartan in Decompensated Heart Failure
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