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NCT05991219 Clinical Trial

Screening and Secondary Prevention Rheumatic Heart Disease Study

Rheumatic Heart Disease Clinical Trial

— S2-RHD  

Official title:
Screening and Secondary Prevention Rheumatic Heart Disease

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05991219
Other study ID # IRB-32/2023
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 26, 2022
Est. completion date December 31, 2028

Study information
Verified date August 2023
Source National Institute of Cardiovascular Diseases, Pakistan
Contact Sabha Bhatti, MD
Phone +92 335 5554346
Email drsabhabhatti@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 5000
Est. completion date December 31, 2028
Est. primary completion date December 31, 2028
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 30 Years
Eligibility Inclusion Criteria: - Rural communities in Sindh Exclusion Criteria: - Refused to participate in the study

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Pakistan National Institute of Cardiovascular Diseases (NICVD) Karachi Sindh

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Cardiovascular Diseases, Pakistan

Country where clinical trial is conducted

Pakistan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rheumatic heart disease Number of patients At the time of screening echocardiogram
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