September 12, 2019 – Precision medicine could someday improve heart failure care by identifying high-risk patients and personalizing heart failure therapies, according to a scientific statement from the American Heart Association (AHA), published in the journal Circulation: Genomic and Precision Medicine.
Precision medicine aims to personalize patient care instead of taking a “one-size-fits-all” approach. By using information about a person’s genetic makeup, metabolism, and other biological and environmental factors, providers can determine what strategies will better treat or prevent a health condition.
AHA sought to provide a state-of-the-science overview of heart failure, examining how it relates to precision medicine and how different people may respond to different treatments.
“We aim to improve care for everyone with heart failure by more clearly defining the best treatment options for specific groups of people,” said Sharon Cresci, MD, chair of the statement writing group and associate professor of medicine and genetics at Washington University in St. Louis, Missouri. “This statement details the potential of precision medicine to improve patient outcomes.”
Research studies have shown that certain drugs can be effective for treating heart failure, and the prognosis for these patients has improved over the last several years. However, within these clinical trial groups there are people who don’t respond to treatment or experience serious side effects.
“Major clinical trials often treat large numbers of patients with one medication, and if there is a positive result, the use of that medication is likely to be incorporated into guidelines for treatment,” Cresci said.
“Yet, within the large group of clinical trial participants, there are often some with no response and some with an adverse response. Precision medicine approaches can help us identify who those non-responders or adverse responders are likely to be so we can find different treatment options for them.”
Increasing the diversity of clinical trial populations will be key to identifying these patients.
“Historically, clinical trial participants have been predominantly white people with particular genetic variants. People with different racial and ethnic ancestry have different genetic variants, therefore, they may not have the same response to a medication or other treatment,” Cresci said.
“Researchers conducting clinical trials recognize this issue and are trying to increase diversity among clinical trial participants so we can find the optimal treatment approaches for each population group.”
The FDA has consistently stressed the importance of increasing diversity in clinical trial populations. In 2017, the agency released a report indicating that clinical trials may not be representing real-world demographic patterns: Just 48 percent of drug testing populations consisted of women, and only seven percent of those who participated in clinical trials were African American.
Recently, the FDA issued draft guidelines designed to help clinical trial sponsors improve enrollment diversity, discussing the importance of broadening eligibility criteria, leveraging different trial methods, and considering participation challenges.
Having clinical trial populations that more closely reflect real-world demographics will help advance precision medicine for heart failure and other diseases. Right now, providers are using some aspects of precision medicine to treat heart failure, including a biomarker called B-type natriuretic peptide. But other features of precision medicine still have some progress to make before they can transform heart failure care.
“The use of biomarkers is probably the most advanced aspect of precision medicine currently used in the treatment of heart failure. Most others are still in their infancy, and we hope in the future to combine multiple aspects of precision medicine to improve patient care and outcomes,” Cresci said.
In addition to broader research, the industry will need to leverage advanced tools and skills in artificial intelligence and data science to better match heart failure patients with treatments.
“This statement also outlines how advances in technology have and can be used to precisely define variability within population groups, and how these advances can be applied to specific patients with heart failure,” said Naveen L. Pereira, MD, vice-chair of the scientific statement writing committee and professor of medicine and associate professor of pharmacology at the Mayo Clinic College of Medicine in Rochester, Minnesota.
“A composite of results from these various precision medicine techniques may also allow us to identify previously undiscovered biology that could lead to the discovery of new medications and treatments for people with heart failure.”
Through further research and practice, precision medicine techniques could become the new standard of care for heart failure and other conditions.
“The field of precision medicine is still in its infancy, with infrastructure and programs to be built. We’ll need specialized training for clinicians, processes for sharing information across large databases and guarantees for patient privacy,” Cresci said. “It’s exciting to realize the potential life-saving innovations on the horizon through precision medicine.”