Losartan in Decompensated Heart Failure

Phase 4

Completed

• Conditions: Congestive Heart Failure; Low Cardiac Output
• Interventions: Drug: Placebo; Drug: Losartan

• Registration Number: NCT01857999
• Lead Sponsor: InCor Heart Institute

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.

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2011-02
• Status Verified: 2011-03
• Study Completion: 2011-03
• Study First Submitted: 2013-05-16
• Study First Submitted QC: 2013-05-17
• Last Update Submitted: 2013-05-17
• Study First Posted: 2013-05-20
• Last Update Posted: 2013-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo 1 pill bid orally
Losartan	Losartan	Losartan 50 mg bid orally

Primary Outcome Measures

Name	Time	Method
B-type natriuretic peptide	7 days	Serum B-type natriuretic peptide

Secondary Outcome Measures

Name	Time	Method
Successful withdrawal from dobutamine	7 days	Successful withdrawal from dobutamine with clinical stability
Worsening renal function	7 days	Increase \> 0.3 mg/dL in serum creatinine
Hyperkalemia	7 days	Serum potassium \> 5.5 mEq/L
Hypotension	7 days	Systolic blood pressure \< 80 mmHg

Trial Locations

Locations (1)

Cotoxó Hospital, Heart Institute (InCor), University of São Paulo; 🇧🇷 São Paulo, SP, Brazil