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This is a randomized pharmacological study evaluating the effects of ivabradine in patients with residual angina after PCI. The role of ivabradine in patients with angina, without systolic dysfunction, is not yet clear. The investigators performed in all patients an echostress to evaluate the effects of therapy with ivabradine after 30 days in terms of exercise tolerance and diastolic function.
BACKGROUND. Residual angina after PCI is a frequently-occurring disease. Ivabradine improves symptoms but its role in patients without left-ventricular systolic dysfunction is still unclear. The aim was to quantify the effects of ivabradine in terms of MVO2 indicators and diastolic function.
METHODS. 28 consecutive patients with residual angina after PCI were randomized to ivabradine 5 mg twice/day(IG) or standard therapy(CG). All patients performed a stress echocardiography at the enrollment and after 30 days. Myocardial oxygen consumption was estimated from: double product(DP); triple product(TP) integrating DP with ejection-time(ET). Diastolic function was evaluated determining E and A waves, E' measurements and E/E' ratio both at rest and at the peak of exercise.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | drug therapy according to the guidelines | |
| Ivabradine Group | Experimental | drug therapy according to the guidelines + Ivabradine 5 mg twice a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ivabradine | Drug | Ivabradine 5 mg twice a day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Double product (DP) calculated as a product between HR and systolic blood pressure. (unit of measure: beats per minute x mmHg) | These, indirectly, reflect the true myocardial oxygen consumption (MVO2) and the improvement of mechanical load that the ventricle can withstand at different levels of exercise. | 30 days |
| Triple product (TP), calculated as a product between HR, systolic blood pressure and ejection time. (unit of measure: beats per minute x mmHg x msec) | These, indirectly, reflect the true myocardial oxygen consumption (MVO2) and the improvement of mechanical load that the ventricle can withstand at different levels of exercise. | 30 days |
| chronotropic reserve (unit of measure: beats per minute) | difference between resting heart rate and maximum heart rate at peak exercise | 30 days |
| muscular work (unit of measure: watt) | These, indirectly, reflect the myocardial oxygen consumption (MVO2) and the improvement of mechanical load that the ventricle can withstand at different levels of exercise. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| diastolic function: PW Doppler E wave (unit of measure: cm/sec) | ventricular filling echocardiographic parameter | 30 days |
| diastolic function: TDI derived E' measurements (unit of measure: cm/sec) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Massimo Mancone | Department of Cardiovascular disease, Sapienza, University of Rome, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massimo Mancone | Rome | 00100 | Italy |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 15, 2015 | Mar 5, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077550 | Ivabradine |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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ventricular filling echocardiographic parameter. Mitral annular E' velocity was estimated as the average between lateral and septal velocity.
| 30 days |
| diastolic function: PW Doppler A wave (unit of measure: cm/sec) | ventricular filling echocardiographic parameter | 30 days |
| E/E' ratio | ventricular filling echocardiographic parameter. TDI derived E' measurements (unit of measure: cm/sec). PW Doppler E wave (unit of measure: cm/sec) | 30 days |
| D014652 |
| Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |