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Precision Treatment With Angiotensin Converting Enzyme Inhibitor

Sponsor
Yonsei University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05535595
Collaborator
(none)
184
Enrollment
1
Location
35.8
Anticipated Duration (Months)
5.1
Patients Per Site Per Month

Study Details

Study Description

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 observational study, in which the experimental group decides whether to administer the drug based on genetic mutation information, and the control group decides whether to administer the drug without genetic mutation 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 each group, 92 participants will be enrolled, 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    184 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Precision Treatment Based on Genetic Information Associated With Response to Angiotensin Converting Enzyme Inhibitor
    Actual Study Start Date :
    Nov 6, 2019
    Anticipated Primary Completion Date :
    Nov 1, 2022
    Anticipated Study Completion Date :
    Nov 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    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.
    Control

    Participants will receive ACEI without genetic study.

    Outcome Measures

    Primary Outcome Measures

    1. Adverse reaction to ACEI or ARB [3 weeks after administration of drug.]

      Common reaction: cough, hypotension, dizziness, dyspnea Uncommon reaction: chest pain, edema, creatinine elevation, headache, etc.

    2. Adverse reaction to ACEI or ARB [6 weeks after administration of drug.]

      Common reaction: cough, hypotension, dizziness, dyspnea Uncommon reaction: chest pain, edema, creatinine elevation, headache, etc.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Men and women over 20 years of age and less than 80 years of age

    • Patients taking ACEI due to hypertension, heart failure, or vascular disease

    • Patients who voluntarily decided to participate after hearing the clinical study explanation

    Exclusion Criteria:

    • Patients who refused to participate in the study

    • Patients with a history of adverse reactions to ACEI

    • Patients with contraindications to the use of ACEI

    • Patients who participated in other clinical trials within 30 days of screening

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yonsei University Health System, Severance Hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • Yonsei University

    Investigators

    • Principal Investigator: Sang-Hak Lee, Division of Cardiology, Severance Hospital, Yonsei University College of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yonsei University
    ClinicalTrials.gov Identifier:
    NCT05535595
    Other Study ID Numbers:
    • 4-2019-0916
    First Posted:
    Sep 10, 2022
    Last Update Posted:
    Sep 10, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cardiovascular Diseases
    Atherosclerosis

    Study Results

    No Results Posted as of Sep 10, 2022