NCT06485661

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)

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Jan 2024

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

July 16, 2024

Status Verified

June 1, 2024

Enrollment Period

9 months

First QC Date

June 27, 2024

Last Update Submit

July 13, 2024

Conditions

Effect of Drug

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Duchenne patients subjected to captopril

OTHER
Drug: Captopril Tablets

Interventions

Captopril TabletsDRUG

Patients will be given captopril to see effect on global longitudinal strain

Duchenne patients subjected to captopril

Eligibility Criteria

Age6 Years+
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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%.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams university

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Captopril

Intervention Hierarchy (Ancestors)

ProlineImino AcidsAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Mona Mostafa Rayan, MD

    Professor of cardiology -Ain Shams university

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatma Ebeid, MD

CONTACT

00201095569596dr.fatma_ebeid@yahoo.com

Sandra M Mina

CONTACT

01060781869sandramourad922@yahoo.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2024

First Posted

July 3, 2024

Study Start

January 1, 2024

Primary Completion

September 30, 2024

Study Completion

September 30, 2024

Last Updated

July 16, 2024

Record last verified: 2024-06

Locations

EG(1)