Montefiore Einstein researchers will be conducting a clinical trial this year to investigate the effects of chronic administration of sildenafil on vascular remodeling during LVAD support. Led by Dr. Omar Saeed, MD, MSc, Associate Professor of Medicine (Cardiology) at Montefiore Einstein and principal investigator, this research study aims to address a critical challenge in the management of advanced heart failure (HF) during heart assist device support—severe vascular adverse events, such as stroke and bleeding, which affect nearly half of LVAD recipients and are a major barrier to safely expanding the use and durability of this life-saving therapy. 

Contemporary LVAD therapy, though transformative for individuals with advanced HF, can produce conditions of reduced pulsatility in the bloodstream, accelerating vascular remodeling or aging of the large and small blood vessels. These vascular changes are known to promote stroke and bleeding within the general population. Since phosphodiesterase-5 inhibitors (PDE5i), such as sildenafil, can enhance nitric oxide–cGMP signaling in platelets and vascular smooth muscle cells lining blood vessels, leading to anti-thrombotic and anti-fibrotic effects, they may also potentially reduce vascular remodeling and related adverse events. 

Dr. Saeed and Montefiore Einstein collaborators have already demonstrated that PDE5i may show promise in mitigating these adverse effects, discovering an association between PDE5i use and lower risk of ischemic stroke during LVAD support. Building on these discoveries, Dr. Saeed and his team will conduct a double-blind, randomized, placebo-controlled,interventional trial to determine the effects of chronic oral sildenafil use on vascular remodeling and maintenance of blood vessel health during LVAD support in adults (ages 18 years and older). If it is determined that sildenafil can reduce vascular remodeling during LVAD therapy, the research findings could prompt its use to potentially prevent or reduce serious vasculogenic adverse events, including stroke and bleeding, benefitting and redefining care for individuals with HF and paving the way for safer LVAD therapy. The data may also provide a rationale to assess other populations at risk for vascular disease, including those with hypertension and diabetes mellitus. 

Montefiore Einstein continues to remain at the forefront of innovation in cardiology and committed to improving the lives of individuals with heart failure. We’re ranked in the top 1% of all hospitals in the nation for Cardiology, Heart & Vascular Surgery according to U.S. News & World Report and are an international referral site for the most complex cases. 

If you are interested in participating or enrolling a patient in this clinical trial, please call 718-920-2626.

Clinical Trial: NCT06510322