HypertensionPhase 4NCT05535595
Precision Treatment With Angiotensin Converting Enzyme Inhibitor
A Phase 4 study testing genotyping and selection of renin-angiotensin system blocker and Perindopril in people with Hypertension, run by Yonsei University at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Hypertension
- What is being tested?
- genotyping and selection of renin-angiotensin system blocker and Perindopril
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Nov 2019to 2 Aug 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women over 20 years of age and less than 79 years of age
- Hypertension
- No history of ACEI use
Who cannot join
- Acute coronary syndrome, cerebrovascular accident, symptomatic peripheral artery disease, or coronary revascularization in the past three months
- Decompensated heart failure
- Systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg
- Hemoglobin A1c >9.0%
- Thyroid dysfunction
- Serum transaminase >2 times the upper limit of normal levels
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- Serum creatinine >2.0 mg/dL
- Cancer
- Pregnant or breast-feeding women, and women of childbearing potential
- Patients who refused to participate
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Health System, Severance Hospital
Seoul
About this study
Official title: Precision Treatment Based on Genetic Information Associated With Response to Angiotensin Converting Enzyme Inhibitor
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.
- Conditions
- Hypertension
- Being tested
- genotyping and selection of renin-angiotensin system blocker, Perindopril
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genotyping and selection of renin-angiotensin system blockerDrug
One of perindopril or candesartan was chosen based on genotyping results on two NELL1 variants.
- perindopril 4 mg/d after genotyping
- candesartan 8 mg/d after genotyping
PerindoprilDrug
perindopril 4 mg/d without genotyping
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | This group will perform genetic study for predicting adverse reaction to ACEI. Based on the result of genetic study, participants will receive ACEI or ARB. Receives: Drug: genotyping and selection of renin-angiotensin system blocker |
| Control | Active comparator | Participants will receive ACEI without genetic study. Receives: Drug: Perindopril |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of cough
Measured: 6 weeks after administration of drug
Incidence of moderate/severe cough
Measured: 6 weeks after administration of drug
Secondary outcomes (1)
Incidence of any adverse events
Measured: 6 weeks after administration of drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start6 Nov 2019
- Primary completion2 Aug 2021
- Study completion2 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sang-Hak Lee, Principal investigator, Division of Cardiology, Severance Hospital, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05535595
- Sponsor's protocol ID
- 4-2019-0916
- Status last verified
- Jan 2023
- First submitted
- 7 Sep 2022
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lee SH, Lee CJ, Kang Y, Park JM, Lee JH. A randomized trial of genotype-guided perindopril use. J Hypertens. 2023 Nov 1;41(11):1768-1774. doi: 10.1097/HJH.0000000000003536. Epub 2023 Aug 17.
PubMed 37602458
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Treatment Based on Genetic Information Associated With Response to Angiotensin Converting Enzyme Inhibitor
- ClinicalTrials.gov ID
- NCT05535595
- Acronym / sponsor ID
- 4-2019-0916
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 6 Nov 2019 (actual)
- Primary completion
- 2 Aug 2021 (actual)
- Study completion
- 2 Aug 2021 (actual)
- First posted
- 10 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: genotyping and selection of renin-angiotensin system blockerThis group will perform genetic study for predicting adverse reaction to ACEI. Based on the result of genetic study, participants will receive ACEI or ARB. |
| Control | Active comparator | Drug: PerindoprilParticipants will receive ACEI without genetic study. |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women over 20 years of age and less than 79 years of age
- Hypertension
- No history of ACEI use
Key exclusion criteria (10 listed)
- Acute coronary syndrome, cerebrovascular accident, symptomatic peripheral artery disease, or coronary revascularization in the past three months
- Decompensated heart failure
- Systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg
- Hemoglobin A1c >9.0%
- Thyroid dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| genotyping and selection of renin-angiotensin system blockerOne of perindopril or candesartan was chosen based on genotyping results on two NELL1 variants. * perindopril 4 mg/d after genotyping * candesartan 8 mg/d after genotyping | Drug | Experimental |
| Perindoprilperindopril 4 mg/d without genotyping | Drug | Control |
Primary outcome
Incidence of cough
Time frame: 6 weeks after administration of drug
Incidence of moderate/severe cough
Time frame: 6 weeks after administration of drug
1 secondary outcome
Incidence of any adverse events
Time frame: 6 weeks after administration of drug
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Derived from this study: PubMed 37602458Lee SH, Lee CJ, Kang Y, Park JM, Lee JH. A randomized trial of genotype-guided perindopril use. J Hypertens. 2023 Nov 1;41(11):1768-1774. doi: 10.1097/HJH.0000000000003536. Epub 2023 Aug 17.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang-Hak Lee principal investigator
Division of Cardiology, Severance Hospital, Yonsei University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing genotyping and selection of renin-angiotensin system blocker and Perindopril in people with Hypertension, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of cough (time frame: 6 weeks after administration of drug). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05535595, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2023.