The Effect of Nebivolol in Hypertensive Patients With Coronary Arterial Spasm

Summary

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.

Conditions

• Coronary Vasospasm

Interventions

DRUG

Nebivolol

Patients are randomly assigned to a ratio of 1: 1: 1, divided into 3 groups.

DRUG

Diltiazem

Patients are randomly assigned to a ratio of 1: 1: 1, divided into 3 groups.

DRUG

Nebivolol+Diltiazem

Patients are randomly assigned to a ratio of 1: 1: 1, divided into 3 groups.

Sponsors & Collaborators

• Korea University Guro Hospital

  collaborator OTHER

• Korea University Ansan Hospital

  collaborator OTHER

• Severance Hospital

  collaborator OTHER

• Korea University Anam Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-01-01

Primary Completion

2019-03-31

Completion

2019-03-31

Countries

• South Korea

Study Locations