Clinical trial NCT02234063: Genetic Testing to Understand and Address Renal Disease Disparities
Official title: Genomic Medicine Pilot for Hypertension and Kidney Disease in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Chronic Kidney Disease
Genomics
Keywords: Hypertension
Chronic Kidney Disease
End Stage Renal Disease
APOL1
Genomics
Genetics
Community-engaged
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2014-09-09
Enrollment: 2052
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of Participants With Urine Protein Excretion
timeFrame: Baseline and 12 months
measure: Change in Systolic Blood Pressure
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Number of Participants With Change in Medication Adherence
timeFrame: 3 months
measure: Number of Patients With Changes in Psychosocial Behaviors
timeFrame: 3 months
measure: Number of Participants With Attitude Towards Genetic Testing
timeFrame: 3 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Institute for Family Health
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Erwin Bottinger, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Carol R Horowitz, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.