Study aims to compare the I(f) inhibitor ivabradine with placebo as strategy of heart rate control in patients with decompensated heart failure (DHF).
Sympathetic hyperactivity and consequent increase in heart rate (HR) are physiological responses to low cardiac output in patients with decompensated heart failure (DHF). However, elevated HR may become inappropriate in these patients, increasing myocardial oxygen demand and decreasing diastolic filling time and might lead to hemodynamic deterioration, ventricular dysfunction (tachycardiomyopathy) and clinical deterioration. Studies show the elevated HR is a predictor of poor prognosis in DHF. Subanalyses of large clinical trials using beta blockers (BBs) demonstrate the adequate control of HR correlates with a better outcome in patients with stable chronic heart failure (HF). However, use of BBs in patients with DHF is limited due to negative inotropic and hypotensive effects of these drugs. As alternative to BBs, ivabradine has shown to increase survival of patients with chronic stable systolic HF. Compared to BBs, ivabradine has the advantage of "pure" negative chronotropic effect, no effect on myocardial contractility or peripheral vascular resistance. Despite the inhibition of I (f) has been validated as a therapeutic option in patients with stable HF, there are no studies available on this strategy in patients with DHF. We hypothesized that HR control by ivabradine might improve clinical, hemodynamic and neurohormonal parameters in patients with DHF. The aim of this study was to evaluate the efficacy of HR control with ivabradine in patients with DHF.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
5 mg oral twice daily
A placebo pill (identical to ivabradine) will be administered twice daily
Heart Failure Unit, Heart Institute, University of Sao Paulo Medical School
São Paulo, São Paulo, Brazil
RECRUITINGChange from baseline heart rate
Heart rate will be assessed at morning, after 30 minutes of rest, recorded by electrocardiogram.
Time frame: Baseline, day 5 after intervention
Change from baseline blood pressure
Blood pressure will be measured at morning by electronic cuff
Time frame: Baseline, day 5 after intervention
Change from baseline ejection fraction
Ejection fraction will be measured by echocardiography using Simpson´s rule
Time frame: Baseline, day 5 after intervention
Change from baseline stroke volume
Stroke volume will be measured by echocardiography using Doppler velocity-time integral technique.
Time frame: Baseline, day 5 after intervention
Change from baseline creatinine
Serum creatinine will be measured
Time frame: Baseline, day 5 after intervention
Change from baseline brain natriuretic peptide
Serum brain natriuretic peptide will be measured
Time frame: Baseline, day 5 after intervention
Clinical
Time of survival and free of readmission
Time frame: Up to 6 months
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