The National Institutes of Health will fund clinical trials to assess the benefits, applicability and efficacy of applying genomic medicine interventions to improve management of diseases such as high blood pressure, depression and chronic pain. The trials are part of the second phase of the Implementing Genomics in Practice (IGNITE) Network with a total investment of $42 million over five years, pending the availability of funds. The trials will begin in 2020.
The first trial will examine whether early access to patients' genomic data can help with treatment of high blood pressure, hypertension and chronic kidney disease. Both hypertension and high blood pressure exacerbate end-stage kidney diseases, and all three conditions are more common among people of African ancestry than European and Asian descent. Specific African populations have two common mutations in the apolipoprotein L1 (APOL1) gene that increase susceptibility to severe kidney disease by a factor of 10. Researchers will compare whether medical intervention provided to those tested for the APOL1 variant immediately after recruitment versus those tested three months later will have subsequent benefits.
The second trial will focus on pain and depression - two conditions where finding safe and effective drug treatments have been difficult. Because there are few clinically useful predictors for whether a depression treatment will be successful, patients often struggle to find effective therapies. To combat these issues, the study seeks to test whether patients with acute post-surgical pain, chronic pain and depression have better clinical outcomes if pharmacogenomics guide opioid and antidepressant prescriptions. In pharmacogenomics, information about a patient's genetic makeup helps determine how they will respond to certain drug treatments.
These projects build upon the first phase of research from the IGNITE Network, which the National Human Genome Research Institute (NHGRI) funded in spring 2013 and focused on challenges and possible solutions to incorporating genomic information into electronic health records. With the beginning of these clinical trials, the network aims to develop and facilitate the application of genomics to diverse clinical care settings.
"Patients of African ancestry might experience better management of high blood pressure and improved prevention of kidney disease caused by high blood pressure. Treatment of depression and/or pain in patients regardless of race or ethnicity may be more effective and have fewer side effects when using a genomic approach to prescribing drugs for these conditions," said Simona Volpi, program director of IGNITE pragmatic clinical trials.
Research teams at the University of Florida, Gainesville; the University of Indiana, Bloomington; Duke University, Durham, North Carolina; Vanderbilt University, Nashville, Tennessee; and the Icahn School of Medicine at Mount Sinai, New York City; will carry out the clinical trials as part of the IGNITE Network.
The National Human Genome Research Institute (NHGRI) is one of the 27 institutes and centers at the NIH, an agency of the Department of Health and Human Services. The NHGRI Division of Intramural Research develops and implements technology to understand, diagnose and treat genomic and genetic diseases. Additional information about NHGRI can be found at: https://www.genome.gov.
National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 institutes and centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical and translational medical research, and is investigating the causes, treatments and cures for both common and rare diseases. For more information about NIH and its programs, visit https://www.nih.gov.