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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.
Selected patients have chronic heart failure with left ventricular systolic dysfunction and sinus rhythm. They take optimal medical therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ivabradine | Experimental | 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. |
|
| Digoxin | Experimental | Digoxin: Digoxin 0,25 mg once a day 5 days per week during 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digoxin | Drug |
| ||
| Ivabradine |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalization for a cardiovascular reason | Up to 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kurtulus Karauzum, MD | Contact | 90 555 726 87 90 | kurtuluskarauzum@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Kurtulus Karauzum, MD | Kocaeli University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kocaeli University | Recruiting | Kocaeli | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D004077 | Digoxin |
| D000077550 | Ivabradine |
| ID | Term |
|---|---|
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
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|
| 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 |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |