Losartan in Decompensated Heart Failure

Congestive Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01857999
• Other study ID #: INCOR 2993/07/008
• Status: Completed
• Phase: Phase 4
• First received: May 16, 2013
• Last updated: May 17, 2013
• Start date: September 2008
• Est. completion date: March 2011

Study information

• Verified date: March 2011
• Source: InCor Heart Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Output, Low
• Congestive Heart Failure
• Heart Failure
• Low Cardiac Output

Intervention

Drug:
• Losartan

• Placebo

Locations

Country	Name	City	State
Brazil	Cotoxó Hospital, Heart Institute (InCor), University of São Paulo	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
InCor Heart Institute

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	B-type natriuretic peptide	Serum B-type natriuretic peptide	7 days	No
Secondary	Successful withdrawal from dobutamine	Successful withdrawal from dobutamine with clinical stability	7 days	No
Secondary	Worsening renal function	Increase > 0.3 mg/dL in serum creatinine	7 days	Yes
Secondary	Hyperkalemia	Serum potassium > 5.5 mEq/L	7 days	Yes
Secondary	Hypotension	Systolic blood pressure < 80 mmHg	7 days	Yes