Genetic Testing to Understand and Address Renal Disease Disparities (GUARDD)
Primary Purpose
Hypertension, Chronic Kidney Disease, Genomics
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Immediate Genetic Testing
Sponsored by
About this trial
This is an interventional prevention trial for Hypertension focused on measuring Hypertension, Chronic Kidney Disease, End Stage Renal Disease, APOL1, Genomics, Genetics, Community-engaged
Eligibility Criteria
Inclusion Criteria:
- Ages18-65
- Self-identifies as Black/African American
- History of hypertension
- Patient at a participating site
Exclusion Criteria:
- History of Chronic Kidney Disease
- History of Diabetes
- Pregnant
- Cognitively impaired/unable to provide consent
- Terminally ill
- Planning to leave area of study permanently during the one year study period
Sites / Locations
- Institute for Family Health
- Icahn School of Medicine at Mount Sinai
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Immediate Genetic Testing
Control- Delayed Testing
Arm Description
Participants randomized to intervention will receive the APOL1 genetic test upon study enrollment.
Participants randomized to control will not receive the APOL1 genetic test upon study enrollment. They will be offered the option to take the test during their final follow-up study visit (12 months post enrollment).
Outcomes
Primary Outcome Measures
Number of Participants With Urine Protein Excretion
Number of participants with urine protein excretion in urine tests to assess kidney function at 12 months as compared to baseline
Change in Systolic Blood Pressure
Change in systolic blood pressure at 3 months as compared to baseline
Secondary Outcome Measures
Number of Participants With Change in Medication Adherence
Participant surveys (self-report) regarding medication adherence behaviors 3 months after randomization
Number of Patients With Changes in Psychosocial Behaviors
Number of patients with changes in psychosocial behaviors 3 months after randomization
Number of Participants With Attitude Towards Genetic Testing
Patient attitude towards genetic testing 3 months after randomization
Full Information
NCT ID
NCT02234063
First Posted
September 4, 2014
Last Updated
September 10, 2020
Sponsor
Icahn School of Medicine at Mount Sinai
1. Study Identification
Unique Protocol Identification Number
NCT02234063
Brief Title
Genetic Testing to Understand and Address Renal Disease Disparities
Acronym
GUARDD
Official Title
Genomic Medicine Pilot for Hypertension and Kidney Disease in Primary Care
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
January 12, 2018 (Actual)
Study Completion Date
January 12, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Chronic Kidney Disease, Genomics
Keywords
Hypertension, Chronic Kidney Disease, End Stage Renal Disease, APOL1, Genomics, Genetics, Community-engaged
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2052 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Immediate Genetic Testing
Arm Type
Experimental
Arm Description
Participants randomized to intervention will receive the APOL1 genetic test upon study enrollment.
Arm Title
Control- Delayed Testing
Arm Type
No Intervention
Arm Description
Participants randomized to control will not receive the APOL1 genetic test upon study enrollment. They will be offered the option to take the test during their final follow-up study visit (12 months post enrollment).
Intervention Type
Other
Intervention Name(s)
Immediate Genetic Testing
Other Intervention Name(s)
Genetic Risk Communication
Intervention Description
Participants will receive the APOL1 genetic test. Trained research staff will meet with participants to communicate results and lifetime ESRD risk attributable to variations in the APOL1 gene. Primary care providers will receive APOL1 genetic risk information via a best practice alert in the participant's EMR upon commencement of a patient encounter and through results filed in the participant's genetics results section of their EMR.
Primary Outcome Measure Information:
Title
Number of Participants With Urine Protein Excretion
Description
Number of participants with urine protein excretion in urine tests to assess kidney function at 12 months as compared to baseline
Time Frame
Baseline and 12 months
Title
Change in Systolic Blood Pressure
Description
Change in systolic blood pressure at 3 months as compared to baseline
Time Frame
Baseline and 3 months
Secondary Outcome Measure Information:
Title
Number of Participants With Change in Medication Adherence
Description
Participant surveys (self-report) regarding medication adherence behaviors 3 months after randomization
Time Frame
3 months
Title
Number of Patients With Changes in Psychosocial Behaviors
Description
Number of patients with changes in psychosocial behaviors 3 months after randomization
Time Frame
3 months
Title
Number of Participants With Attitude Towards Genetic Testing
Description
Patient attitude towards genetic testing 3 months after randomization
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Ages18-65
Self-identifies as Black/African American
History of hypertension
Patient at a participating site
Exclusion Criteria:
History of Chronic Kidney Disease
History of Diabetes
Pregnant
Cognitively impaired/unable to provide consent
Terminally ill
Planning to leave area of study permanently during the one year study period
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erwin Bottinger, MD, MPH
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carol R Horowitz, MD, MPH
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Family Health
City
New York
State/Province
New York
ZIP/Postal Code
10006
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35244702
Citation
Nadkarni GN, Fei K, Ramos MA, Hauser D, Bagiella E, Ellis SB, Sanderson S, Scott SA, Sabin T, Madden E, Cooper R, Pollak M, Calman N, Bottinger EP, Horowitz CR. Effects of Testing and Disclosing Ancestry-Specific Genetic Risk for Kidney Failure on Patients and Health Care Professionals: A Randomized Clinical Trial. JAMA Netw Open. 2022 Mar 1;5(3):e221048. doi: 10.1001/jamanetworkopen.2022.1048.
Results Reference
derived
Links:
URL
https://ignite-genomics.org/
Description
Implementing GeNomics In PracTicE (IGNITE) Network Website
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Genetic Testing to Understand and Address Renal Disease Disparities
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