Losartan in Decompensated Heart Failure

NCT ID: NCT01857999

Last Updated: 2013-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2011-03-31

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.

Conditions

Congestive Heart Failure; Low Cardiac Output

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Losartan

Losartan 50 mg bid orally

Group Type: EXPERIMENTAL

Losartan

Intervention Type: DRUG

Placebo

Placebo 1 pill bid orally

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Losartan

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

InCor Heart Institute

OTHER

Sponsor Role: lead

Responsible Party

Marcelo Eidi Ochiai

Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antonio P Barretto, Ph.D.

Role: STUDY_DIRECTOR

Heart Institute (InCor), University of São Paulo

Locations

Cotoxó Hospital, Heart Institute (InCor), University of São Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 24838894 (View on PubMed)

Other Identifiers

INCOR 2993/07/008

Identifier Type: -

Identifier Source: org_study_id