Clinical trial NCT01857999: Losartan in Decompensated Heart Failure
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Congestive Heart Failure
Low Cardiac Output
Keywords: Renin-aldosterone system
Hemodynamic
Low cardiac output
Vasodilation
Natriuretic peptide
Lead sponsor: InCor Heart Institute
Sponsor class: OTHER
First posted: 2013-05-20
Enrollment: 21
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: B-type natriuretic peptide
timeFrame: 7 days
Secondary outcomes:
measure: Successful withdrawal from dobutamine
timeFrame: 7 days
measure: Worsening renal function
timeFrame: 7 days
measure: Hyperkalemia
timeFrame: 7 days
measure: Hypotension
timeFrame: 7 days
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Cotoxó Hospital, Heart Institute (InCor), University of São Paulo
state: SP
Study officials:
affiliation: Heart Institute (InCor), University of São Paulo
name: Antonio P Barretto, Ph.D.
role: STUDY_DIRECTOR
References:
citation: 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.