Losartan in Decompensated Heart Failure

University of São Paulo (USP)

Status and phase: Completed; Phase 4

Conditions: Low Cardiac Output; Congestive Heart Failure

Treatments: Drug: Losartan; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01857999

INCOR 2993/07/008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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21 participants in 2 patient groups, including a placebo group

Losartan

Experimental group

Description:

Losartan 50 mg bid orally

Treatment:

Drug: Losartan

Placebo

Placebo Comparator group

Description:

Placebo 1 pill bid orally

Treatment:

Drug: Placebo