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S2-RHD: Screening and Secondary Prevention Rheumatic Heart Disease Study

Sponsor
National Institute of Cardiovascular Diseases, Pakistan (Other)
Overall Status
Recruiting
CT.gov ID
NCT05991219
Collaborator
(none)
5,000
Enrollment
1
Location
75.2
Anticipated Duration (Months)
66.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

After basic clinical screening including history and physical, Point of care ultrasound will be performed to look at Mitral, Aortic and Tricuspid Valves for regurgitation or stenosis. For patients with confirmed Rheumatic heart disease (RHD), treatment and referral depending on stage of disease. Antibiotic prescription could be shifted to community health workers delivering preventive medications via practical clinical algorithms, diagnostic tools, availability of appropriate antibiotics, and supportive supervision. Patients will have repeat imaging at 2 years and 5 years to look at the outcome of delayed progression of valve disease.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Screening for RHD should be carried out since it is a major health concern that has been shown to have a treatable and detectable latent stage that can be diagnosed using a simple sensitive test (point of care ultrasound) and early treatment (secondary prevention using antibiotic prophylaxis) can provide a better outcome (slow progression of disease) in a cost effective way. The investigators aim to study the Incidence and Prevalence of RHD in community and school settings and aim to intervene depending on the stage the disease is picked up in.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    5000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Screening and Secondary Prevention Rheumatic Heart Disease
    Actual Study Start Date :
    Sep 26, 2022
    Anticipated Primary Completion Date :
    Dec 31, 2028
    Anticipated Study Completion Date :
    Dec 31, 2028

    Outcome Measures

    Primary Outcome Measures

    1. Rheumatic heart disease [At the time of screening echocardiogram]

      Number of patients

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years to 30 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Rural communities in Sindh
    Exclusion Criteria:
    • Refused to participate in the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Institute of Cardiovascular Diseases (NICVD) Karachi Sindh Pakistan 75510

    Sponsors and Collaborators

    • National Institute of Cardiovascular Diseases, Pakistan

    Investigators

    • Principal Investigator: Sabha Bhatti, MD, National Institute of Cardiovascular Diseases

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sabha Bhatti, Professor, National Institute of Cardiovascular Diseases, Pakistan
    ClinicalTrials.gov Identifier:
    NCT05991219
    Other Study ID Numbers:
    • IRB-32/2023
    First Posted:
    Aug 14, 2023
    Last Update Posted:
    Aug 15, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Rheumatic Heart Disease
    Rheumatic Diseases
    Heart Diseases

    Study Results

    No Results Posted as of Aug 15, 2023