Clinical trial NCT05535595: Precision Treatment With Angiotensin Converting Enzyme Inhibitor
Official title: Precision Treatment Based on Genetic Information Associated With Response to Angiotensin Converting Enzyme Inhibitor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2022-09-10
Enrollment: 77
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of cough
timeFrame: 6 weeks after administration of drug
measure: Incidence of moderate/severe cough
timeFrame: 6 weeks after administration of drug
Secondary outcomes:
measure: Incidence of any adverse events
timeFrame: 6 weeks after administration of drug
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
affiliation: Division of Cardiology, Severance Hospital, Yonsei University College of Medicine
name: Sang-Hak Lee
role: PRINCIPAL_INVESTIGATOR
References: