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临床试验/NCT05535595
NCT05535595已完成4 期

Precision Treatment Based on Genetic Information Associated With Response to Angiotensin Converting Enzyme Inhibitor

Yonsei University1 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2019年11月6日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
77
试验地点
1
主要终点
Incidence of cough

研究概览

简要总结

Angiotensin converting enzyme inhibitors (ACEI) are the first-line treatment for high blood pressure and congestive heart failure, and have excellent effects in improving the prognosis of cardiovascular diseases. However, ACEI is frequently discontinued due to its adverse reaction. The adverse reaction to ACEI is not uncommon, especially in Asians. Discontinuation of ACEI is known to increase the risk of poor prognosis of cardiovascular diseases.

Biomarkers for predicting adverse reaction to ACEI have not yet been developed. Recently, genes related to adverse reaction to ACEI have been identified. This study is a randomized prospective study, in which the experimental group decides whether to administer the drug based on genetic information, and the control group decides whether to administer the drug without the information. In the experimental group, participants who are predicted to have a high risk of adverse reation to ACEI will receive angiotensin receptor blockers (ARB), and those who are predicted to have a low risk of adverse reaction will receive ACEI. Control group will receive ACEI. The frequency of adverse reaction will be investigated between control and experimental groups. In the genotyping and control groups, at least 45 and 31 will be enrolled, respectively, and after drug administration, a phone follow-up will be conducted at 3 weeks, followed by a visit at the 6th week, and the study will be terminated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women over 20 years of age and less than 79 years of age
  • Hypertension
  • No history of ACEI use

排除标准

  • Acute coronary syndrome, cerebrovascular accident, symptomatic peripheral artery disease, or coronary revascularization in the past three months
  • Decompensated heart failure
  • Systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg
  • Hemoglobin A1c >9.0%
  • Thyroid dysfunction
  • Serum transaminase >2 times the upper limit of normal levels
  • Serum creatinine >2.0 mg/dL
  • Pregnant or breast-feeding women, and women of childbearing potential
  • Patients who refused to participate

研究组 & 干预措施

Experimental

Experimental

This group will perform genetic study for predicting adverse reaction to ACEI. Based on the result of genetic study, participants will receive ACEI or ARB.

干预措施: genotyping and selection of renin-angiotensin system blocker (Drug)

Control

Active Comparator

Participants will receive ACEI without genetic study.

干预措施: Perindopril (Drug)

结局指标

主要结局

Incidence of cough

时间窗: 6 weeks after administration of drug

Incidence of moderate/severe cough

时间窗: 6 weeks after administration of drug

次要结局

  • Incidence of any adverse events(6 weeks after administration of drug)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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