Ignite Creation Date:
2024-05-06 @ 3:13 AM
Last Modification Date:
2024-10-26 @ 11:30 AM
Study NCT ID:
NCT02234063
Status:
COMPLETED
Last Update Posted:
2020-10-05
First Post:
2014-09-04
Brief Title:
Genetic Testing to Understand and Address Renal Disease Disparities
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
Genomic Medicine Pilot for Hypertension and Kidney Disease in Primary Care
Status:
COMPLETED
Status Verified Date:
2020-09
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:
GUARDD
Brief Summary:
In this genomic medicine implementation pilot project the investigators aim to conduct a randomized trial in a network of community health centers and primary care facilities to study processes effects and challenges of incorporating information for apolipoprotein L1 APOL1-attributable genetic risk for end stage kidney disease in patients of African ancestry with hypertension
Detailed Description:
CKD is most commonly associated with diabetes 40 and hypertension 28 and affects 26 million American adults African ancestry populations with hypertension HTN have 2- to 3-fold higher risk of developing CKD and a 5-fold increased risk to progress to end stage renal disease ESRD when compared with whites HTN is a risk factor for progression of CKD and for increased cardiovascular risk with CKD Thus targeting blood pressure control as a modifiable risk factor may both reduce CVD in people with CKD and reduce progression of CKD to end stage disease Recent discoveries demonstrate that testable alleles of the APOL1 locus on chromosome 22 have a major effect on and explain almost all of the excess risk for hypertension-associated CKD and its progression to ESRD in African ancestry populations
We will use community-engaged approaches to enroll patients of African Ancestry with HTN from a network of community health centers and primary care facilities in Harlem and the Bronx and randomize them on a 7 to 1 ratio to receive APOL1 genetic testing and EMR-enabled provider clinical decision support incorporating APOL1 genomic risk information
We will use community-engaged approaches to enroll patients of African Ancestry with HTN from a network of community health centers and primary care facilities in Harlem and the Bronx and randomize them on a 7 to 1 ratio to receive APOL1 genetic testing and EMR-enabled provider clinical decision support incorporating APOL1 genomic risk information
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None