A Phase 4 interventional study of Digoxin and Ivabradine in Heart Failure, sponsored by Kocaeli University. Status unknown at 1 site in Turkey. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-01-27.
Sponsored by Kocaeli University · Phase 4, Interventional, and Treatment
Study hypothesis: Comparing the effect of digoxin and ivabradine in chronic heart failure patients with a left ventricular ejection of 35% or lower and sinus rhythm with heart rate 70 beats per minute or higher, and who are taking maximal dose of a beta blocker if tolerated.
Selected patients have chronic heart failure with left ventricular systolic dysfunction and sinus rhythm. They take optimal medical therapy.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 60 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Kocaeli University is the lead sponsor of 210 studies on the registry; 38 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Left ventricular ejection fraction of 35% or lower (Ischaemic or non-ischaemic etiology)
Chronic renal failure with glomerular filtration rate \<30 ml/min
Ivabradine: initial dose of 5 mg b.id. dose up-titration to 7,5 mg b.id. in 2 weeks due to the heart rate and maintaining the last dose during 6 months.
Drug: Ivabradine
Digoxin: Digoxin 0,25 mg once a day 5 days per week during 6 months.
Drug: Digoxin
Cardiac function and functional status and biochemical parameters
Cardiac function (echocardiography): Systolic function (left ventricular ejection fraction) and diastolic function (Doppler E/A ratio, tissue Doppler e/e1 ratio, Doppler deceleration time of the E wave, left atrium volume index) Maximal oxygen consumption will be evaluated with cardiopulmonary exercise testing Changes in proBNP level (serum value) after treatment
Time frame: After 6 months
Cardiovascular mortality
Death from cardiovascular reasons
Time frame: Up to 6 months
All cause mortality
Death from any cause.
Time frame: Up to 6 months
Hospital admission for worsening heart failure
Time frame: Up to 6 months
Heart rate and blood pressure
Changes in heart rate and blood pressure.
Time frame: After 6 months
Hospitalization for a cardiovascular reason
Time frame: Up to 6 months
This study is status unknown, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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Kocaeli University