A Pharmacogenomics Study of Safety and Efficacy of Enalapril or Enalapril-Folic Acid Therapy in Hypertensive Patients.

• Sponsor: Cui Yimin (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03259399
• Collaborator: (none)
• Enrollment: 2,200
• Location: 1
• Anticipated Duration (Months): 33.5
• Patients Per Site Per Month: 65.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Enalapril Adverse Reaction; Pharmacogenomics; Stroke	Genetic: detection of genotype

Study Design

• Study Type: Observational
• Anticipated Enrollment: 2200 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: 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.
• Actual Study Start Date: Aug 16, 2017
• Anticipated Primary Completion Date: Jun 1, 2020
• Anticipated Study Completion Date: Jun 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
wild genotype Detection of genotype will be carried out through next generation sequencing, distinguish wild genotype of enalapril	Genetic: detection of genotype; detection of genotype by next generation sequencing
mutant genotype Detection of genotype will be carried out through next generation sequencing, distinguish mutant genotype of enalapril	Genetic: detection of genotype; detection of genotype by next generation sequencing

Outcome Measures

Primary Outcome Measures

1. Incidence of dry cough [At 2 years]

2. First Incidence of stroke [At 2 years]

Secondary Outcome Measures

1. Genotype detected by next generation sequencing [pre-dose of enalapril or enalapril-folic acid (Baseline)]

   Collect blood specimen before enalapril administration, then detect genotype of enalapril by next generation sequencing.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University First Hospital	Beijing	Beijing	China	100034

Sponsors and Collaborators

• Cui Yimin

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cui Yimin, Director of pharmacy，M.D & Ph.D, Peking University First Hospital
• ClinicalTrials.gov Identifier: NCT03259399
• Other Study ID Numbers: 2016[1238]
• First Posted: Aug 23, 2017
• Last Update Posted: Aug 28, 2019
• Last Verified: Aug 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stroke

Study Results

No Results Posted as of Aug 28, 2019