Screening and Secondary Prevention Rheumatic Heart Disease Study

NCT ID: NCT05991219

Last Updated: 2023-08-15

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-26
• Study Completion Date: 2028-12-31

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.

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.

Conditions

Rheumatic Heart Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

• Rural communities in Sindh

Exclusion Criteria

• Refused to participate in the study

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Cardiovascular Diseases, Pakistan

OTHER

Sponsor Role: lead

Responsible Party

Sabha Bhatti

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sabha Bhatti, MD

Role: PRINCIPAL_INVESTIGATOR

National Institute of Cardiovascular Diseases

Locations

National Institute of Cardiovascular Diseases (NICVD)

Karachi, Sindh, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Sabha Bhatti, MD

Role: CONTACT

drsabhabhatti@gmail.com

+92 335 5554346

Other Identifiers

IRB-32/2023

Identifier Type: -

Identifier Source: org_study_id