Rheumatic Heart Disease Research and Screening in Nepal: A Feasibility Study

Rheumatic Heart Disease Clinical Trial

Official title: Rheumatic Heart Disease Research and Screening in Nepal: A Feasibility Study

Status Active, not recruiting

Clinical Trial Summary

Rheumatic Heart Disease (RHD) remains a significant public health problem in lower and middle-income countries, accounting for over 300,000 deaths world-wide. RHD is a sequela of Acute Rheumatic Fever (ARF) caused by Group A Streptococcus (GAS). Benzathine Penicillin Prophylaxis (BPP), through tri-weekly intramuscular injection of benzathine penicillin G, remains the mainstay of intervention to delay and prevent the sequelae among ARF and RHD patients by preventing repeat GAS infections. Two major obstacles exist to the optimal utilization of this effort. First, despite proven benefits, BPP adherence remains low. Unfortunately, there is very little knowledge on the factors associated with BPP adherence. Even in countries like Nepal, which has a nation-wide free BPP program serving about 6000 patients, there is absence of a robust system to prospectively track and study these patients. Second, largely because RHD is initially asymptomatic, only a fraction of those who would benefit are enrolled in BPP programs. There is a dearth of information and evidence on potentially high-yield approaches like the screening of first-degree relatives (FDRs) of RHD patients to identify asymptomatic, early-stage RHD patients who may benefit from BPP. The investigators will combine the resources and expertise at the University of Washington with those from existing partners at two leading Nepali hospitals (Manmohan Cardiothoracic Vascular and Transplant Center and Dhulikhel Hospital) to first create an easy to use, scalable, comprehensive electronic RHD registry and enroll BPP patients from these sites. In Aim 1, the investigators will examine whether patient socio-demographic, clinical, and health services-related characteristics are associated with BPP adherence. Investigators will use the BPP registry to collect important covariate information and adherence outcomes to address this aim. In Aim 2, investigators will determine the feasibility of screening FDRs of known RHD patients. Investigators will invite FDRs of known RHD patients (enrolled in the BPP registry) for echocardiographic screening for RHD. Investigators will assess the prevalence of RHD in these FDRs. This proposal harnesses one of the largest RHD patient pools in the world for establishing a robust RHD-related quality improvement and research platform that serves as a solid foundation for conducting larger epidemiologic, interventional, and implementation studies on RHD risk, prevention, and treatment.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Heart Diseases
• Rheumatic Diseases
• Rheumatic Heart Disease

• NCT number: NCT05250154
• Study type: Observational
• Source: University of Washington
• Status: Active, not recruiting
• Start date: August 27, 2018
• Completion date: May 1, 2040