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.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 2,200
- Locations
- 1
- Primary Endpoint
- Incidence of dry cough
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients taking enalapril or enalapril-folic acid therapy
- •Signed informed consent.
Exclusion Criteria
- •Patients not taking enalapril treated
- •Intolerance or unwillingness to blood sample collection.
Outcomes
Primary Outcomes
Incidence of dry cough
Time Frame: At 2 years
First Incidence of stroke
Time Frame: At 2 years
Secondary Outcomes
- Genotype detected by next generation sequencing(pre-dose of enalapril or enalapril-folic acid (Baseline))
Investigators
Cui Yimin
Director of pharmacy,M.D & Ph.D
Peking University First Hospital
