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| Name | Class |
|---|---|
| Korea University Guro Hospital | OTHER |
| Korea University Ansan Hospital | OTHER |
| Severance Hospital | OTHER |
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The correlation between endothelial dysfunction and the risk of coronary heart disease is well known through previous studies. The degradation of the function of nitric oxide acting on the endothelium of blood vessels is mainly explained by reduction of synthesis, loss due to oxidative stress, and decreased sensitivity to vascular dilatation action. In particular, patients with high blood pressure have been known to have impaired vascular endothelial function through animal experiments and several clinical studies, mainly due to increased biomechanical friction in the blood vessels and decreased biological availability of nitric oxide, which in turn causes incongruity in the production of nitric monoxide and changes in normal vascular dilatation. There have also been reports recently that early diagnosis and treatment may improve endothelial dysfunction and prevent the progression of coronary artery disease. However, the reality is that the drugs available in vasospastic angina patients with endothelial dysfunction are very limited. Until recently, beta-blockers were reported to inhibit vascular dilatation of adrenaline stimuli, a drug corresponding to relative contraindications in vasospastic angina patients, with one study reporting that propranolol cannot, but rather exacerbates, vasospastic angina. However, a series of reports on the vascular dilatation of the recently developed third-generation beta-blockers have reinvented the role of beta-blockers in vasospastic angina, especially nebivolol (selective, continuous beta-blockers) is known to act on β-1 adrenaline receptor blockings and endothelium to create vascular dilatation, and also to stimulate β-3 adrenaline receptors to cause nitric oxide generation and antioxidant effects in the endothelium of blood vessels. Therefore, this clinical trial seeks to find whether nebivolol will inhibit vascular contraction in hypertensive patients and will work in angiospastic angina patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nebivolol group | Active Comparator | Oral Nebivolol 5mg / day (2 weeks) -> 10mg / day (10 weeks) |
|
| Diltiazem group | Placebo Comparator | Oral Diltiazem 90mg / day (2 weeks) -> 180mg / day (10 weeks) |
|
| Nebivolol+Diltiazem group | Placebo Comparator | Oral Nebivolol 2.5mg / day + Oral Diltiazem 45mg / day (2 weeks) -> Oral Nebivolol 5mg / day + Oral Diltiazem 90mg / day (10 weeks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nebivolol | Drug | Patients are randomly assigned to a ratio of 1: 1: 1, divided into 3 groups. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in coronary spasm | The descriptive statistics (mean subject number, standard deviation, median value, minimum value, and maximum value) of changes in the baseline and 12-week outcomes will be presented for each treatment group, and the comparison between the three groups for ANOVA or ANOVA Kruskal-Wallis test. Changes in each group will be analyzed using Paired t-test or Wilcoxon signed rank test. An ANCOVA analysis will be performed when there are more influencing factors. | Baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Quality of Life | Changes in Quality of Life based on Seattle Angina Questionnaire | Baseline to 12 weeks |
| Changes in mean sitting systolic blood pressure and mean sitting diastolic blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Anam Hospital | Seoul | 02841 | South Korea |
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| ID | Term |
|---|---|
| D003329 | Coronary Vasospasm |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000068577 | Nebivolol |
| D004110 | Diltiazem |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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Group 1: Nebivolol group Group 2: Diltiazem group Group 2: Nebivolol + Diltiazem group
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| Diltiazem | Drug | Patients are randomly assigned to a ratio of 1: 1: 1, divided into 3 groups. |
|
| Nebivolol+Diltiazem | Drug | Patients are randomly assigned to a ratio of 1: 1: 1, divided into 3 groups. |
|
Changes in mean sitting systolic blood pressure and mean sitting diastolic blood pressure
| Baseline to 6, 12 weeks |
| Percentage of target blood pressure reached | Percentage of target blood pressure reached from baseline to 6, 12 weeks | Baseline to 6, 12 weeks |
| D014652 |
| Vascular Diseases |
| D000588 |
| Amines |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D001552 | Benzazepines |