Cotoxó Hospital, Heart Institute (InCor), University of São Paulo
São Paulo, 05021-010, Brazil
NCT Number: NCT01857999
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.
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Interventional
Phase 4
São Paulo, 05021-010, Brazil
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 7 days
Serum B-type natriuretic peptide
Time frame: 7 days
Successful withdrawal from dobutamine with clinical stability
Time frame: 7 days
Increase > 0.3 mg/dL in serum creatinine
Time frame: 7 days
Serum potassium > 5.5 mEq/L
Time frame: 7 days
Systolic blood pressure < 80 mmHg
InCor Heart Institute
Other
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
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