Ignite Creation Date:
2024-05-06 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 2:25 PM
Study NCT ID:
NCT05250154
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-06-05
First Post:
2021-10-18
Brief Title:
Rheumatic Heart Disease Research and Screening in Nepal A Feasibility Study
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Rheumatic Heart Disease Research and Screening in Nepal A Feasibility Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Rheumatic Heart Disease RHD remains a significant public health problem in lower and middle-income countries accounting for over 300000 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R21TW011108 | NIH | None | httpsreporternihgovquickSearchR21TW011108 |
| R34HL143279 | NIH | None | None |