Screening and Secondary Prevention Rheumatic Heart Disease Study (S2-RHD)

Screening and Secondary Prevention Rheumatic Heart Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Rheumatic Heart 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.

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Sabha Bhatti, MD; Phone Number: +92 335 5554346; Email: drsabhabhatti@gmail.com

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 75510
      • Recruiting
      • National Institute of Cardiovascular Diseases (NICVD)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Age group 10-30 years. Screening in rural communities in Sindh including very low income areas outside Karachi. Schools (free government schools in low income areas) and patient point of contact locations such as National Institute of Cardiovascular Diseases Pakistan Satellite centers (10) and chest pain units (24) will also be utilized. Family members of patients with known rheumatic heart disease will also be screened.

Description

Inclusion Criteria:

• Rural communities in Sindh

Exclusion Criteria:

• Refused to participate in the study

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rheumatic heart disease	Number of patients	At the time of screening echocardiogram

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2022
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: August 6, 2023
• First Submitted That Met QC Criteria: August 6, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): August 15, 2023
• Last Update Submitted That Met QC Criteria: August 12, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Infections; Musculoskeletal Diseases; Connective Tissue Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Rheumatic Fever; Heart Diseases; Rheumatic Diseases; Rheumatic Heart Disease
• Other Study ID Numbers: IRB-32/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No