Most associate February with love and romance, but for some, the month has a different meaning: February is American Heart Month, a federally designated event designed to raise public awareness of cardiovascular disease across the United States.
“Cardiovascular disease creates an incredible burden on both the healthcare system as a whole and on individual patients, their families, and their communities,” said Greg Licholai, MD, MBA, SVP and Chief Medical Information Officer at PRA Health Sciences. “As medical experts, it’s our responsibility to reduce those burdens through innovative research and improvements in patient care.”
For the next 28 days, organizations including the American Heart Association (AHA), the National Institutes of Health (NIH) and the CDC will share everything from patient resources to physician guidance to the latest medical research surrounding heart health. At PRA, we’re also doing our part to innovate, in the form of our groundbreaking partnership with Janssen Pharmaceuticals. Read on for the latest in heart health.
Matters of the Heart
Cases of heart disease in the United States have reached epidemic proportions: it is the leading cause of death among men and women across racial and ethnic lines and is the costliest chronic condition. Data from one AHA report found that cardiovascular disease cost $555 billion in 2016, with a projected economic burden of $1.1 trillion by 2035.
Organizations across the country—including the AHA and the NIH—have redoubled their efforts to emphasize the importance of heart disease prevention. Current public outreach focuses on the simple steps—including regular cholesterol checks, lifestyle modifications, stress management, sleep, and quitting smoking—that people can take to reduce their heart disease risks.
Primordial and primary prevention are two key tenets in public health programs for heart disease. Using evidence-based research, the AHA has developed guidelines for primordial and primary cardiovascular disease preventions across populations—including in children and youth. Developing healthy lifestyle habits and behaviors early in life can reduce a person’s risk for heart disease and associated conditions like obesity and type 2 diabetes.
Where Current Research Stands
Each year, the AHA names the top research advances in both heart disease and stroke. Ten pivotal studies received this honor in 2020, with research focused on topics from hypertrophic cardiomyopathy treatment to how influenza impacts cardiovascular health.
One of these key studies zeroed in on best practices for treating coronary artery disease, the most common type of heart disease in the United States. A team of researchers set out to clarify if—and how—early, aggressive care might prevent future heart problems and cardiovascular-related deaths. Hypertension research was also spotlighted in 2020, with three highlighted studies aimed at closing knowledge gaps related to hypertension prevalence, diagnosis, and treatment.
Heart disease is the leading cause of death for women in the United States, but the dearth of research on the topic is glaring. The FDA’s Office of Women’s Health (OWH) has played an essential role in closing this research gap, supporting numerous studies centered specifically on sex differences in cardiovascular disease. Currently, the OWH is supporting research analyzing sex-specific differences in heart failure quality of life measures, the safety and effectiveness of non-vitamin K antagonist oral anticoagulants for atrial fibrillation, and sex differences in the adverse effects of some drugs on the heart’s electrical cycle.
With the global explosion of COVID-19 cases, most current heart disease research focuses on the intersection of the coronavirus with cardiovascular health. These research efforts are two-pronged: some investigations look backward, seeking to uncover why cardiovascular disease is a significant risk factor for worse COVID-19 outcomes. Other investigations are looking forward, working to determine what long-term impacts COVID-19 infection might have on heart health and how the healthcare system can work to care for those patients.
Where Research is Headed
As with other medical disciplines, cardiology and technology go hand-in-hand. Cardiovascular-specific technologies have exploded, with some currently being used in practice and others still in the research phase.
We're using both Artificial intelligence (AI) and machine learning to enhance the delivery of cardiovascular care. Cardiologists rely heavily on medical imaging to diagnose and monitor numerous conditions, and AI-backed imaging technologies—from ultrasound systems to MRI machines—are reading, processing, and reviewing images before a cardiologist even sees their patient. AI algorithms are also being used in wearables, like the Apple Watch, to record patient ECGs. These at-home patient monitoring systems can help clinicians with triage and result in the earlier detection of cardiovascular diseases.
After the 2019 FDA clearance of transcatheter aortic valve replacement (TAVR), researchers have started evaluating transcatheter mitral valve and tricuspid valve repair and replacement procedures (TMVR and TTVR). Mitraclip is becoming an established standard of care for secondary mitral regurgitation in some patients, and we view TMVR as a “promising emerging alternative” to transcatheter repair for both primary and secondary mitral regurgitation. TTVR is a newer technology attributed to the previously underrecognized role that tricuspid regurgitation plays in patient outcomes. Current medical literature is hopeful for these new therapies, but more research is needed before we can define specific clinical applications.
Heart failure results from many common cardiovascular conditions, including coronary artery disease, high blood pressure, and valvular heart disease. Current management techniques include medication and lifestyle modifications, but recent research is looking to expand that list to include stem cell therapy. In a review of stem cell therapy-based clinical trials, researchers found overall promising results across cohorts of patients with chronic and advanced heart failure. Future research studies will need to evaluate the use of stem cell therapy specifically in patients with reduced ejection fraction heart failure (HFrEF), but initial data are promising.
Staying on the Cutting Edge of Innovation
In 2019, we partnered with Janssen Pharmaceuticals to conduct the first fully decentralized, mobile clinical trial seeking FDA approval of a new drug indication.
In the groundbreaking CHIEF-HF trial, a team of researchers is evaluating the safety and effectiveness of canagliflozin (Invokana) for use in adults with heart failure. Powered by our mobile clinical trial platform trial will measure patient-reported outcomes — a novel measurement method for a trial with an end-goal of regulatory approval and the outcome of FDA policy changes enacted to address the “desperate need” for better heart failure drugs.
“Decentralized clinical trials are paving the way for advances in research, and our partnership with Janssen is just one example,” said Isaac Rodriguez-Chavez, PhD, MHSc, MSc, SVP, Scientific and Clinical Affairs, Global Center of Excellence for DCT. “We’ve worked hard at PRA to perfect our mobile clinical trial platform, and we’re thrilled to be able to use that technology to conduct research that might change the way people with heart failure live their lives. This clinical trial is the first step of many on PRA’s journey to improving global heart health.”
Despite the advances in the cardio-metabolic field over the past 20 years, cardiovascular and metabolic diseases such as coronary artery disease, high blood pressure, diabetes, and dyslipidemia remain the leading causes of morbidity and mortality around the world. While there has been significant progress in the understanding of the pathophysiology and in-patient management, the need to discover and develop better, safer drugs and devices to address patients’ needs remains.
Celebrate American Heart Month with Go Red for Women. American Heart Association. https://www.goredforwomen.org/en/get-involved/give/wear-red-and-give/celebrate-american-heart-month. Updated January 29, 2020. Accessed January 25, 2021.
American Heart Month. National Institutes of Health/National Heart, Lung, and Blood Institute. https://www.nhlbi.nih.gov/health-topics/education-and-awareness/heart-month. Accessed January 25, 2021.
Cardiovascular disease: A costly burden for America—Projections through 2035. American Heart Association. https://www.heart.org/en/get-involved/advocate/federal-priorities/cardiovascular-disease-burden-report. Accessed January 25, 2021.
Weintraub WS, Daniels SR, Burke LE, et al. Value of primordial and primary prevention for cardiovascular disease: A policy statement from the American Heart Association. Circulation. 2011;124(8):967-990. Accessed January 25, 2021.
AHA names top heart disease and stroke research advances of 2020. American Heart Association. https://www.heart.org/en/around-the-aha/aha-names-top-heart-disease-and-stroke-research-advances-of-2020. Updated December 15, 2020. Accessed January 25, 2021.
Heart disease facts. Centers for Disease Control and Prevention. https://www.cdc.gov/heartdisease/facts.htm. Updated September 8, 2020. Accessed January 25, 2021.
Maron DJ, Hochman JS, Reynolds HR, et al; for the ISCHEMIA Research Group. Initial invasive or conservative strategy for stable coronary disease. N Engl J Med. 2020;382(15):1395-1407. Accessed January 25, 2021.
Women and heart disease. Centers for Disease Control and Prevention. https://www.cdc.gov/heartdisease/women.htm. Updated January 31, 2020. Accessed January 25, 2021.
Research on heart disease in women. US Food and Drug Administration. https://www.fda.gov/science-research/womens-health-research/research-heart-disease-women. Updated July 8, 2019. Accessed January 25, 2021.
Current OWH-funded research: Cardiovascular diseases. US Food and Drug Administration. https://www.fda.gov/science-research/womens-health-research/current-owh-funded-research-cardiovascular-diseases. Updated March 27, 2018. Accessed January 25, 2021.
Overtchouk P, Piazza N, Granada J, Soliman O, Prendergast B, Modine T. Advances in transcatheter mitral and tricuspid therapies. BMC Cardiovasc Disord. 2020;20:1. Accessed January 25, 2021.
Heart failure. Centers for Disease Control and Prevention. https://www.cdc.gov/heartdisease/heart_failure.htm. Updated September 8, 2020. Accessed January 25, 2021.
Heart failure. Cleveland Clinic. https://my.clevelandclinic.org/departments/heart/patient-education/recovery-care/heart-failure. Accessed January 25, 2021.
Poglajen G, Frljak S, Zemlijič G, et al. Stem cell therapy for chronic and advanced heart failure. Curr Heart Fail Rep.2020;17(5):261-270. Accessed January 25, 2021.
Nair N, Gongora E. Stem cell therapy in heart failure: Where do we stand today? Biochim Biophys Acta Mol Basis Dis.2020;1866(4):165487. Accessed January 25, 2021.
Licholai G. Janssen Pharmaceuticals and PRA Health Sciences launch first fully virtual trial for heart failure drug approval. PRA Health Sciences. https://prahs.com/insights/janssen-pharmaceuticals-and-pra-health-launch-first-fully-virtual-trial-for-heart-failure-drug-approval. Published November 19, 2019. Accessed January 25, 2021.
We’ve contributed to the successful approval of eight marketed cardiovascular and cardio-metabolic drugs.
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