Heart Rate Control as an Additional Therapeutic Strategy in Patients With Decompensated Heart Failure: a Prospective, Randomized, Double-blinded, Placebo-controlled Study.
Overview
- Phase
- Phase 1
- Intervention
- ivabradine
- Conditions
- Decompensated Heart Failure
- Sponsor
- University of Sao Paulo
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Change from baseline heart rate
- Last Updated
- 9 years ago
Overview
Brief Summary
Study aims to compare the I(f) inhibitor ivabradine with placebo as strategy of heart rate control in patients with decompensated heart failure (DHF).
Detailed Description
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.
Investigators
Marco Stephan Lofrano Alves
MD
University of Sao Paulo
Eligibility Criteria
Inclusion Criteria
- •Sinus node rhythm
- •HR\> 80 bpm
- •Hospitalization for DHF
- •Ejection fraction ≤ 40%
- •Sign informed consent
Exclusion Criteria
- •Systolic blood pressure \<85 mmHg
- •Signs of hypoperfusion
- •Dobutamine\>15 mcg/Kg/min
- •Acute myocarditis
- •Primary valvular disease requiring surgery
- •Stroke in the last three months
- •Hypertrophic or restrictive cardiomyopathy
- •Sinus node disease
- •Atrial fibrillation or flutter
- •Second or third degree atrio-ventricular blockade
Arms & Interventions
ivabradine
I(f) inhibitor, heart rate controller
Intervention: ivabradine
placebo
placebo pill will be administered orally twice daily
Intervention: Placebo
Outcomes
Primary Outcomes
Change from baseline heart rate
Time Frame: Baseline, day 5 after intervention
Heart rate will be assessed at morning, after 30 minutes of rest, recorded by electrocardiogram.
Secondary Outcomes
- Change from baseline blood pressure(Baseline, day 5 after intervention)
- Change from baseline ejection fraction(Baseline, day 5 after intervention)
- Change from baseline stroke volume(Baseline, day 5 after intervention)
- Change from baseline creatinine(Baseline, day 5 after intervention)
- Change from baseline brain natriuretic peptide(Baseline, day 5 after intervention)
- Clinical(Up to 6 months)