By Clinical Informatics News Staff  

 

November 13, 2014 | On Monday, the Icahn School of Medicine at Mount Sinai’s Institute for Personalized Medicine announced a new clinical study to determine how knowledge of a genetic predisposition effects lifestyle changes. 

 

The GUARDD study—Genetic Testing to Understand and Address Renal Disease Disparities—will ask if individuals who are aware of a genetic predisposition to chronic kidney disease are more inclined to engage in proactive lifestyle modification with their primary care physician.

 

Chronic kidney disease affects about 26 million American adults, and African Americans are up to seven times more likely to develop high blood pressure and subsequent complications, such as kidney disease. Mutations in a single gene—apolipoprotein L1 (APOL1)—account for much of that disparity. 

 

“Many patients do not have their blood pressure adequately controlled to minimize the risk for complications such as kidney disease,” said Erwin Bottinger, MD, Director, Charles Bronfman Institute for Personalized Medicine in the Icahn School of Medicine at Mount Sinai and one of the study’s principal investigators. “We will test whether sharing genetic risk information with patients and alerting their doctors through a patient's electronic health record, will achieve better control of blood pressure to reduce kidney disease risk.”

 

The year-long study seeks to enroll approximately two thousand African American participants with hypertension, and will be conducted in a network of community health centers and primary care facilities in Northern Manhattan and the South Bronx, affiliated with the Icahn School of Medicine’s Institute for Family Health and at primary care facilities of The Mount Sinai Health System. The study is funded by the National Human Genome Research Institute (NHGRI). 

 

Study participants will be randomized into two groups. Group one will receive genetic testing at the start of the study. These participants will discuss their results with members of the research team and be given printed information about their test results. Their primary care providers will receive the results of the APOL1 genetic test and information about the test through alerts in the patients’ electronic medical record.  

 

Both groups will return at 3 and 12 months for a blood pressure check and to complete follow-up surveys.

 

“We are translating the latest scientific developments for both patients and their primary care physicians,” says Dr. Horowitz. “While we can’t guarantee results, we are hopeful participants who know they carry the APOL1 gene variant will engage in proactive behaviors, under their doctor’s supervision to forestall renal failure often associated with hypertension.”

 

Individuals in group two will receive genetic testing and their results at the end of the study.