CClinicalTrials.gg
Status unknownNCT03259399Updated Aug 28, 2019

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

An observational study in Enalapril Adverse Reaction, Pharmacogenomics and Stroke, sponsored by Cui Yimin. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-28.

Sponsored by Cui Yimin · Observational

The sponsor has not verified this record recently (last verified Aug 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
2,200
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Enalapril Adverse Reaction
  • Pharmacogenomics
  • Stroke

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Chinese Patients:In accordance with anti-hypertension indications of enalapril

Inclusion criteria

  • Patients taking enalapril or enalapril-folic acid therapy
  • Signed informed consent.

Exclusion criteria

Exclusion Criteria:

  • Patients not taking enalapril treated
  • Intolerance or unwillingness to blood sample collection.
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Study design

Observational model
Cohort
Time perspective
Other
Enrollment
2,200 participants (estimated)
Patient registry
No

Groups and cohorts

  • wild genotype

    Detection of genotype will be carried out through next generation sequencing, distinguish wild genotype of enalapril

    Genetic: detection of genotype

  • mutant genotype

    Detection of genotype will be carried out through next generation sequencing, distinguish mutant genotype of enalapril

    Genetic: detection of genotype

Interventions

  • Geneticdetection of genotype

    detection of genotype by next generation sequencing

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What researchers measure

Primary outcomes

  1. Incidence of dry cough

    Time frame: At 2 years

  2. First Incidence of stroke

    Time frame: At 2 years

Secondary outcomes

  1. Genotype detected by next generation sequencing

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

    Time frame: pre-dose of enalapril or enalapril-folic acid (Baseline)

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Study locations

1 of 1 sites recruiting
  • Peking University First Hospital
    Beijing, Beijing 100034, China
    Recruiting
07

References and documents

Publications

  • Mu 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. PubMed 32397904 ↗
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Registry details

Key details

Study ID
NCT03259399
Lead sponsor
Cui Yimin
Responsible party
Cui Yimin (Director of pharmacy,M.D & Ph.D, Peking University First Hospital) — Sponsor-investigator
First posted
Aug 23, 2017
Start date
Aug 16, 2017
Primary completion
Jun 2020 (estimated)
Completion
Jun 2020 (estimated)
Last update
Aug 28, 2019

Study contacts

Qian Xiang, Ph.D
Contact
xiangqz@126.com
+86 010 66110802

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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