NCT05535595

Precision Treatment With Angiotensin Converting Enzyme Inhibitor

Completed Phase 4 Last updated 11 January 2023

What this trial tests

Phase 4 trial testing genotyping and selection of renin-angiotensin system blocker in Hypertension in 77 participants. Completed in 2 August 2021.

Timeline

6 November 2019

Primary endpoint
2 August 2021

2 August 2021

Quick facts

Lead sponsor	Yonsei University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	77
Start date	6 November 2019
Primary completion	2 August 2021
Estimated completion	2 August 2021
Sites	1 location across South Korea

Drugs / interventions tested

• genotyping and selection of renin-angiotensin system blocker — full drug profile →
• Perindopril — full drug profile →

Conditions studied

• Hypertension — all drugs for Hypertension →

Sponsor

Yonsei University

Who can join

Adults 20 to 79, any sex, with Hypertension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Criteria2Query 3.0: Leveraging generative large language models for clinical trial eligibility query generation.
   Park J, Fang Y, Ta C, Zhang G, et al · · 2024 · cited 21× · PMID 38697494 · DOI 10.1016/j.jbi.2024.104649
2. A randomized trial of genotype-guided perindopril use.
   Lee SH, Lee CJ, Kang Y, Park JM, et al · · 2023 · PMID 37602458 · DOI 10.1097/hjh.0000000000003536