Precision Treatment With Angiotensin Converting Enzyme Inhibitor

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05535595
• Other study ID #: 4-2019-0916
• Status: Completed
• Phase: Phase 4
• Start date: November 6, 2019
• Est. completion date: August 2, 2021

Study information

• Verified date: January 2023
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: August 2, 2021
• Est. primary completion date: August 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• 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
• Perindopril
perindopril 4 mg/d without genotyping

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Health System, Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of cough		6 weeks after administration of drug
Primary	Incidence of moderate/severe cough		6 weeks after administration of drug
Secondary	Incidence of any adverse events		6 weeks after administration of drug