Precision Treatment With Angiotensin Converting Enzyme Inhibitor

Yonsei University

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: genotyping and selection of renin-angiotensin system blocker; Drug: Perindopril

Study type: Interventional

Funder types: Other

Identifiers

NCT05535595

4-2019-0916

Details and patient eligibility

About

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.

Enrollment: 77 patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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77 participants in 2 patient groups

Experimental

Experimental group

Description:

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.

Treatment:

Drug: genotyping and selection of renin-angiotensin system blocker

Control

Active Comparator group

Description:

Participants will receive ACEI without genetic study.

Treatment:

Drug: Perindopril