A Phase 1/2 interventional study of ivabradine and Placebo in Decompensated Heart Failure, sponsored by University of Sao Paulo. Status unknown at 1 site in Brazil. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-01-02.
Sponsored by University of Sao Paulo · Phase 1/2, Interventional, and Treatment
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 50 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
I(f) inhibitor, heart rate controller
Drug: ivabradine
placebo pill will be administered orally twice daily
Drug: Placebo
5 mg oral twice daily
Also known as: procoralan
A placebo pill (identical to ivabradine) will be administered twice daily
Change 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
Safety/Adverse Event Outcome Measure
Number of Participants with Serious and Non-Serious Adverse Events
Time frame: Up to day 15 days after intervention
Plan to share: No
This study is status unknown, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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University of Sao Paulo