NCT05535595

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P25-P50 for phase_4 hypertension

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 6, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 10, 2022

Completed
Last Updated

January 11, 2023

Status Verified

January 1, 2023

Enrollment Period

1.7 years

First QC Date

September 7, 2022

Last Update Submit

January 8, 2023

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

  • Incidence of cough

    6 weeks after administration of drug

  • Incidence of moderate/severe cough

    6 weeks after administration of drug

Secondary Outcomes (1)

  • Incidence of any adverse events

    6 weeks after administration of drug

Study Arms (2)

Experimental

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.

Drug: genotyping and selection of renin-angiotensin system blocker

Control

ACTIVE COMPARATOR

Participants will receive ACEI without genetic study.

Drug: Perindopril

Interventions

genotyping and selection of renin-angiotensin system blockerDRUG

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

Experimental
PerindoprilDRUG

perindopril 4 mg/d without genotyping

Control

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women over 20 years of age and less than 79 years of age
  • Hypertension
  • No history of ACEI use

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Location

Related Publications (1)

  • Lee SH, Lee CJ, Kang Y, Park JM, Lee JH. A randomized trial of genotype-guided perindopril use. J Hypertens. 2023 Nov 1;41(11):1768-1774. doi: 10.1097/HJH.0000000000003536. Epub 2023 Aug 17.

    PMID: 37602458DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

GenotypePerindopril

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Genetic PhenomenaIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Sang-Hak Lee

    Division of Cardiology, Severance Hospital, Yonsei University College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2022

First Posted

September 10, 2022

Study Start

November 6, 2019

Primary Completion

August 2, 2021

Study Completion

August 2, 2021

Last Updated

January 11, 2023

Record last verified: 2023-01

Locations

KR(1)