Digoxin Versus Ivabradine in Heart Failure With Reduced Ejection Fraction

Study Overview
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Brief Summary
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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.

Detailed Description
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Selected patients have chronic heart failure with left ventricular systolic dysfunction and sinus rhythm. They take optimal medical therapy.

Official Title
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Comparing the Effects of Digoxin and Ivabradine on Mortality and Morbidity in Chronic Heart Failure With Reduced Ejection Fraction and Sinus Rhythm

Conditions
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Heart Failure

Intervention / Treatment
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* Drug: Digoxin
* Drug: Ivabradine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Left ventricular ejection fraction of 35% or lower (Ischaemic or non-ischaemic etiology) Sinus rhythm with heart rate of 70 beats per minute or higher Symptomatic heart failure with functional capacity of New York Heart Association class II, III, IV Exclusion Criteria: Chronic renal failure with glomerular filtration rate <30 ml/min Atrial fibrillation Pace maker rhythm Advanced stage chronic obstructive lung disease Comorbidity with expected survival below 1 year

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ivabradine<br>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<br> <br> |
| Experimental: Digoxin<br>Digoxin: Digoxin 0,25 mg once a day 5 days per week during 6 months. | Drug: Digoxin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | After 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular mortality | Death from cardiovascular reasons | Up to 6 months | 
| All cause mortality | Death from any cause. | Up to 6 months | 
| Hospital admission for worsening heart failure |  | Up to 6 months | 
| Heart rate and blood pressure | Changes in heart rate and blood pressure. | After 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart failure, Digoxin, Ivabradine