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

NCT05250154 | Active Not Recruiting

• 3 other identifiers: STUDY00005371R34HL143279R21TW011108
• Study Type: observational
• Target: 2,438
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rheumatic Heart Disease

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Registry of RHD patients

You may qualify if:

• RHD patients

Sponsors & Collaborators

• University of Washington: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (1)

Dhulikhel Hospital

Dhulikhel, Kavre, Nepal

Location

MeSH Terms

Conditions

Rheumatic Heart Disease

Condition Hierarchy (Ancestors)

Rheumatic Fever; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Heart Diseases; Cardiovascular Diseases

Study Officials

• Nona Sotoodehnia, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, School of Medicine

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: February 22, 2022
• Study Start: August 27, 2018
• Primary Completion (Estimated): May 1, 2040
• Study Completion (Estimated): May 1, 2040
• Last Updated: June 5, 2023

Record last verified: 2023-06

Locations

NE (1)