Precision Treatment With Angiotensin Converting Enzyme Inhibitor

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-06

Study Completion Date

2021-08-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

genotyping and selection of renin-angiotensin system blocker

Intervention Type DRUG

One of perindopril or candesartan was chosen based on genotyping results on two NELL1 variants.

* perindopril 4 mg/d after genotyping
* candesartan 8 mg/d after genotyping

Control

Participants will receive ACEI without genetic study.

Group Type ACTIVE_COMPARATOR

Perindopril

Intervention Type DRUG

perindopril 4 mg/d without genotyping

Interventions

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genotyping and selection of renin-angiotensin system blocker

One of perindopril or candesartan was chosen based on genotyping results on two NELL1 variants.

* perindopril 4 mg/d after genotyping
* candesartan 8 mg/d after genotyping

Intervention Type DRUG

Perindopril

perindopril 4 mg/d without genotyping

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No