Effect of Captopril on GLS in Duchenne Myodystrophy | NCT06485661

Studies
Effect of Captopril on GLS in Duchenne Myodystrophy

NCT06485661

Sponsor

Ain Shams University

Status

Unknown status

Last Update Posted

Jul 16, 2024Actual

Enrollment

20Estimated

Phase

Early Phase 1

Conditions

Effect of Drug

Interventions

Captopril Tablets

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2024Actual

Primary Completion Date

Sep 30, 2024Estimated

Completion Date

Sep 30, 2024Estimated

First Submitted Date

Jun 27, 2024

First Submission Date that Met QC Criteria

Jun 27, 2024

First Posted Date

Jul 3, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 13, 2024

Last Update Posted Date

Jul 16, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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)

Detailed Description

ACEI slowing down the onset and the progression of dystrophinopathic cardiomyopathy.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Duchenne patients subjected to captopril	Other		Drug: Captopril Tablets

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Captopril Tablets	Drug	Patients will be given captopril to see effect on global longitudinal strain	Duchenne patients subjected to captopril

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Genetically confirmed Duchenne myodystrophy (DMD) patients with abnormal GLS < -18% with minimum age of 6 years old.

Exclusion Criteria:

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%.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Fatma Ebeid, MD	Contact	00201095569596		dr.fatma_ebeid@yahoo.com
Sandra M Mina	Contact	01060781869		sandramourad922@yahoo.com

Overall Officials

Name	Affiliation	Role
Mona Mostafa Rayan, MD	Professor of cardiology -Ain Shams university	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain Shams university	Recruiting	Cairo			Egypt

Intervention Browse Module

MeSH Terms

ID	Term
D002216	Captopril

Ancestor Terms

ID	Term
D011392	Proline
D007098	Imino Acids
D000598	Amino Acids, Cyclic
D000596	Amino Acids

Browse Leaves

Not provided

Browse Branches

Not provided