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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05250154
• Other study ID #: STUDY00005371
• Secondary ID: R34HL143279R21TW
• Status: Active, not recruiting
• Start date: August 27, 2018
• Est. completion date: May 1, 2040

Study information

• Verified date: June 2023
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2438
• Est. completion date: May 1, 2040
• Est. primary completion date: May 1, 2040
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• RHD patients Exclusion Criteria: -

Related Conditions & MeSH terms

• Heart Diseases
• Rheumatic Diseases
• Rheumatic Heart Disease

Locations

Country	Name	City	State
Nepal	Dhulikhel Hospital	Dhulikhel	Kavre

Sponsors (3)

Lead Sponsor	Collaborator
University of Washington	Fogarty International Center of the National Institute of Health, National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression of rheumatic heart disease valve measured using standard imaging protocols	We will use standard imaging protocols to evaluate mitral, aortic, and tricuspid valves, which will allow analysis according to the World Heart Federation criteria for echocardiographic diagnosis of RHD among adults	20 years
Primary	Adherence to BPP measured using proportion of days covered.	The BPP clinic staff will enter information on injection every three weeks and will make a note of any clinical events during the preceding 3 weeks as reported by the patients. We will prospectively follow for one year all patients recruited in the first six weeks. At one year, we will assess the adherence to BPP. We will measure adherence using the proportion of days covered (PDC). PDC, a commonly used pharmacy quality measure for oral medications, has been adapted for injectable BPG in prior reports.	20 years