Losartan in Decompensated Heart Failure

Sponsor

InCor Heart Institute (Other)

Overall Status

Completed

CT.gov ID

NCT01857999

Collaborator

(none)

Enrollment

Location

Arms

29.9

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Congestive Heart Failure Low Cardiac Output	Drug: Losartan Drug: Placebo	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Sep 1, 2008

Actual Primary Completion Date :

Feb 1, 2011

Actual Study Completion Date :

Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Losartan Losartan 50 mg bid orally	Drug: Losartan
Placebo Comparator: Placebo Placebo 1 pill bid orally	Drug: Placebo

Arm

Intervention/Treatment

Experimental: Losartan

Losartan 50 mg bid orally

Drug: Losartan

Placebo Comparator: Placebo

Placebo 1 pill bid orally

Drug: Placebo

Outcome Measures

Primary Outcome Measures

B-type natriuretic peptide [7 days]
Serum B-type natriuretic peptide

Secondary Outcome Measures

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