Effect of DrugEarly Phase 1NCT06485661
Effect of Captopril on GLS in Duchenne Myodystrophy
A Early Phase 1 study testing Captopril Tablets in people with Effect of Drug, run by Ain Shams University at 1 site in Egypt.
Trial summary
To outline the intermediate term effect of prescribing Captopril as an add on therapy on Left ventricular functions as measured by Global longitudinal strain in patients with Duchenne myodystrophy (DMD) Read more about this study
- Who is it for?
- Ages 6 years and older, men only
- Conditions the study is for
- Effect of Drug
- What is being tested?
- Captopril Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 30 Sep 2024
- Phase
- Early Phase 1
- 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 6 years and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Genetically confirmed Duchenne myodystrophy (DMD) patients with abnormal GLS < -18% with minimum age of 6 years old.
Who cannot join
- Any patient who refuses to sign an informed consent.
- Contraindication to ACEI: hypersensitivity - renal impairment - bilateral renal artery stenosis - aortic valve stenosis - hyperkalemia - hypotension.
- Reduced ejection fraction below 50%.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams university
Cairo
Fatma Ebeid, MD, 00201095569596, dr.fatma_ebeid@yahoo.com
Sandra M Mina, 01060781869, sandramourad922@yahoo.com
About this study
Official title: Intermediate Term Effect of Captopril on Left Ventricle Global Longitudinal Strain in Patients With Duchenne Myodystrophy
To outline the intermediate term effect of prescribing Captopril as an add on therapy on Left ventricular functions as measured by Global longitudinal strain in patients with Duchenne myodystrophy (DMD)
Read the detailed description
ACEI slowing down the onset and the progression of dystrophinopathic cardiomyopathy.
To outline the intermediate term effect of prescribing Captopril as an add on therapy on Left ventricular functions as measured by Global longitudinal strain in patients with Duchenne myodystrophy (DMD
- Conditions
- Effect of Drug
- Being tested
- Captopril Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Captopril TabletsDrug
Patients will be given captopril to see effect on global longitudinal strain
| Study group | Role | What they receive |
|---|---|---|
| Duchenne patients subjected to captopril | Other | Not described Receives: Drug: Captopril Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
The impaired global longitudinal strain will change in echo in the number of participants with duchenne myodystrophy
Impaired Global longitudinal strain will be changed in echo after 6 months of treatment with Captopril in patients with duchenne myodystrophy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Jan 2024
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of DrugStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mona Mostafa Rayan, MD, Principal investigator, Professor of cardiology -Ain Shams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485661
- Sponsor's protocol ID
- MS180/2024
- Status last verified
- Jun 2024
- First submitted
- 27 Jun 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermediate Term Effect of Captopril on Left Ventricle Global Longitudinal Strain in Patients With Duchenne Myodystrophy
- ClinicalTrials.gov ID
- NCT06485661
- Acronym / sponsor ID
- MS180/2024
- Conditions
- Effect of Drug
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 3 Jul 2024 (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.
To outline the intermediate term effect of prescribing Captopril as an add on therapy on Left ventricular functions as measured by Global longitudinal strain in patients with Duchenne myodystrophy (DMD)
Detailed description
ACEI slowing down the onset and the progression of dystrophinopathic cardiomyopathy.
To outline the intermediate term effect of prescribing Captopril as an add on therapy on Left ventricular functions as measured by Global longitudinal strain in patients with Duchenne myodystrophy (DMD
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Duchenne patients subjected to captopril | Other | Drug: Captopril Tablets |
Who may qualify
- Ages
- 6 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Genetically confirmed Duchenne myodystrophy (DMD) patients with abnormal GLS < -18% with minimum age of 6 years old.
Key exclusion criteria (3 listed)
- Any patient who refuses to sign an informed consent.
- Contraindication to ACEI: hypersensitivity - renal impairment - bilateral renal artery stenosis - aortic valve stenosis - hyperkalemia - hypotension.
- Reduced ejection fraction below 50%.
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 |
|---|---|---|
| Captopril TabletsPatients will be given captopril to see effect on global longitudinal strain | Drug | Duchenne patients subjected to captopril |
Primary outcome
The impaired global longitudinal strain will change in echo in the number of participants with duchenne myodystrophy
Time frame: 6 months
Impaired Global longitudinal strain will be changed in echo after 6 months of treatment with Captopril in patients with duchenne myodystrophy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
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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.
Mona Mostafa Rayan, MD principal investigator
Professor of cardiology -Ain Shams university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Captopril Tablets in people with Effect of Drug, run by Ain Shams University at 1 site in Egypt.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 16 Jul 2024. 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 Egypt. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatma Ebeid, MD (00201095569596, dr.fatma_ebeid@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The impaired global longitudinal strain will change in echo in the number of participants with duchenne myodystrophy (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2024.