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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01857999
Enrollment
21
Registered
2013-05-20
Start date
2008-09-30
Completion date
2011-03-31
Last updated
2013-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congestive Heart Failure, Low Cardiac Output

Keywords

Renin-aldosterone system, Hemodynamic, Low cardiac output, Vasodilation, Natriuretic peptide

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.

Interventions

DRUGLosartan
DRUGPlacebo

Sponsors

InCor Heart Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
B-type natriuretic peptide7 daysSerum B-type natriuretic peptide

Secondary

MeasureTime frameDescription
Successful withdrawal from dobutamine7 daysSuccessful withdrawal from dobutamine with clinical stability
Worsening renal function7 daysIncrease \> 0.3 mg/dL in serum creatinine
Hyperkalemia7 daysSerum potassium \> 5.5 mEq/L
Hypotension7 daysSystolic blood pressure \< 80 mmHg

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026