A Pharmacogenomics Study of Safety and Efficacy of Enalapril or Enalapril-Folic Acid Therapy in Hypertensive Patients.
A Study of Genetic Variants Associated With Enalapril-Induced Adverse Drug Reaction and Impact of Pharmacogenomics on First Stroke in Hypertensive Patients Taking Enalapril or Enalapril-Folic Acid Therapy.
1 other identifier
observational
2,200
1 country
1
Brief Summary
Dry cough is the most common adverse reaction of angiotensin converting enzyme, including enalapril, in Chinese population. Clinical observations suggest that the incidence of ACEI-induced dry cough is different between Chinese and other racial groups, however, there is still lack of research data in Chinese. Stroke is the second leading cause of death in the world and leading cause of death in China. Except the known risk factor such as hypertension, high homocysteine level, folic acid deficiency, the impact of genetics should not be ignored. In this study, we will investigate whether there are specific genotypes which may predict the incidence of (1)enalapril-induced dry cough in Chinese and (2)first stroke in hypertensive patients taking enalapril or enalapril-folic acid therapy, so as to provide a basis for developing guidelines on precision medication in enalapril therapy apply to Chinese population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 16, 2017
CompletedFirst Submitted
Initial submission to the registry
August 21, 2017
CompletedFirst Posted
Study publicly available on registry
August 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedAugust 28, 2019
August 1, 2019
2.8 years
August 21, 2017
August 27, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Incidence of dry cough
At 2 years
First Incidence of stroke
At 2 years
Secondary Outcomes (1)
Genotype detected by next generation sequencing
pre-dose of enalapril or enalapril-folic acid (Baseline)
Study Arms (2)
wild genotype
Detection of genotype will be carried out through next generation sequencing, distinguish wild genotype of enalapril
mutant genotype
Detection of genotype will be carried out through next generation sequencing, distinguish mutant genotype of enalapril
Interventions
detection of genotype by next generation sequencing
Eligibility Criteria
Chinese Patients:In accordance with anti-hypertension indications of enalapril
You may qualify if:
- Patients taking enalapril or enalapril-folic acid therapy
- Signed informed consent.
You may not qualify if:
- Patients not taking enalapril treated
- Intolerance or unwillingness to blood sample collection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cui Yiminlead
Study Sites (1)
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Related Publications (2)
Mu G, Xie Q, Liu Z, Zhang H, Meng X, Song J, Zhou S, Wang Z, Wang Z, Zhao X, Jiang J, Liao M, Bao J, Zhang F, Xiang Q, Cui Y. Identification of genetic biomarkers associated with pharmacokinetics and pharmacodynamics of apixaban in Chinese healthy volunteers. Expert Opin Drug Metab Toxicol. 2023 Jan;19(1):43-51. doi: 10.1080/17425255.2023.2184344. Epub 2023 Mar 3.
PMID: 36867504DERIVEDMu G, Xiang Q, Zhang Z, Liu C, Zhang H, Liu Z, Pang X, Jiang J, Xie Q, Zhou S, Wang Z, Hu K, Wang Z, Jiang S, Qin X, Cui Y. PNPT1 and PCGF3 variants associated with angiotensin-converting enzyme inhibitor-induced cough: a nested case-control genome-wide study. Pharmacogenomics. 2020 Jun;21(9):601-614. doi: 10.2217/pgs-2019-0167. Epub 2020 May 13.
PMID: 32397904DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director of pharmacy，M.D & Ph.D
Study Record Dates
First Submitted
August 21, 2017
First Posted
August 23, 2017
Study Start
August 16, 2017
Primary Completion
June 1, 2020
Study Completion
June 1, 2020
Last Updated
August 28, 2019
Record last verified: 2019-08