Precision Treatment With Angiotensin Converting Enzyme Inhibitor

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Drug: genotyping and selection of renin-angiotensin system blocker; Drug: Perindopril

• Registration Number: NCT05535595
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-06
• Primary Completion: 2021-08-02
• Study Completion: 2021-08-02
• Study First Submitted: 2022-09-07
• Study First Submitted QC: 2022-09-07
• Study First Posted: 2022-09-10
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-08
• Last Update Posted: 2023-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

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

Exclusion Criteria

• 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
• Cancer
• Pregnant or breast-feeding women, and women of childbearing potential
• Patients who refused to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	genotyping and selection of renin-angiotensin system blocker	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.
Control	Perindopril	Participants will receive ACEI without genetic study.

Primary Outcome Measures

Name	Time	Method
Incidence of cough	6 weeks after administration of drug
Incidence of moderate/severe cough	6 weeks after administration of drug

Secondary Outcome Measures

Name	Time	Method
Incidence of any adverse events	6 weeks after administration of drug

Trial Locations

Locations (1)

Yonsei University Health System, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of