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Completed

NCT Number: NCT05535595

Precision Treatment With Angiotensin Converting Enzyme Inhibitor

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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Key information

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

genotyping and selection of renin-angiotensin system blocker

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

perindopril

Drug

perindopril 4 mg/d without genotyping

Primary outcomes

  1. Incidence of cough

    Time frame: 6 weeks after administration of drug

  2. Incidence of moderate/severe cough

    Time frame: 6 weeks after administration of drug

Secondary outcomes

  1. Incidence of any adverse events

    Time frame: 6 weeks after administration of drug

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 10, 2022
Registry last updated
Jan 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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