Heart failure

Clinical trial reveals promising developments for heart failure

In time for World Heart Month, Parasym in partnership with the University of Oklahoma, announce groundbreaking research into the neuromodulation treatment of heart failure.

The randomized controlled trial, led by lead researcher Dr. Stavros Stavrakis of the University of Oklahoma Health Sciences Center, used Parasym neuromodulation device for significantly improving cardiac mechanics and quality of life, and reducing inflammatory markers in a patient population that historically has very few treatment options available. The positive results pave the way for a new era of heart failure treatment.

Currently, heart disease is the leading cause of death worldwide, claiming an estimated 17.9 million lives each year. One person dies every 36 seconds in the United States from heart disease. In the UK, heart and circulatory disease cause a quarter of all deaths, a staggering average of 460 deaths per day. As the fastest growing form of heart disease, heart failure accounts for a significant proportion of all cases.

The current landscape of heart failure is complex as there is no cure for this debilitating disease. Until Parasym launched the first neuromodulation device of its kind, there have been no clinically validated, non-invasive, non-pharmacological options for people suffering from heart failure and its plethora of life-altering symptoms. Up to a quarter of patients report intermediate to severe depression associated with heart disease, as it has a significant impact on their quality of life. Until now, depression as a side effect is something the medical field has not focused on when it comes to treating heart failure because, naturally, their priority has been the prevention of deaths and hospitalizations. Additionally, there are many possible risks and side effects of taking medications to treat the disease, which are mainly triggered by the right medication getting into the wrong place. Whereas neuromodulation and electroceuticals have the ability to provide highly targeted treatment.

Current treatment advises lifestyle changes and medication, which is not without side effects. Electroceuticals are poised to revolutionize the heart failure treatment paradigm, particularly neuromodulation with its ability to provide highly targeted treatment without drug interactions or side effects.

Clinical trial results using Parasym’s neuromodulation device demonstrate that Parasym – the only non-invasive, low-risk, minimal side-effect option – significantly improved the quality of life for patients with heart failure. The device works by stimulating the vagus nerve and sending signals to the brain, which favorably alters the nervous system and reduces inflammation in the heart.

Clinical results of using neuromodulation to help significantly relieve symptoms of heart failure showed that patients who participated in the placebo-controlled study experienced measurable improvements after just three months of treatment. use of the device for less than one hour per day. The study found significant improvements in levels of pro-inflammatory cytokines, interleukin-8 and tumor necrosis factor alpha, indicating that the treatment had a significant anti-inflammatory effect, as well as overall longitudinal tension, a central indicator of heart mechanics.

Importantly, patients also reported improvements in their quality of life and daily activities, which surgery and medication struggle to provide. Additionally, since the neuromodulation device is non-invasive, patients can use it alongside medications if they wish. This approach fills a gap by addressing the patient’s overall quality of life, as well as improving their mental health which is affected by living with the disease.

Sophie Dundovic, co-founder of Parasym commented: “The international impact of heart failure on our population is staggering, with millions suffering daily from symptoms affecting their quality of life. Parasym™️ is committed to supporting groundbreaking cardiac research and we work to bring non-invasive electroceutical treatments to patients with heart failure.

“The results published in the Journal of the American Heart Association highlight the brilliant work done by researchers at the University of Oklahoma and show the incredible potential that Parasym’s neuromodulating technology can have in a state where there is an urgent unmet clinical need for new treatment options. . We are incredibly proud of the trial results and look forward to continuing to demonstrate the positive impact of neuromodulation in healthcare.

Dr. Stavros Stavrakis MD, PhD, Associate Professor, University of Oklahoma Medical School commented, “We conducted a randomized, double-blind, sham-controlled clinical trial to examine the effect of chronic stimulation of the Low-level transcutaneous vagus nerve on cardiac function, exercise capacity and inflammation in a subgroup of heart failure patients with preserved ejection fraction with a predominantly inflammatory metabolic phenotype. In this patient population, neuromodulation with transcutaneous low-level vagus nerve stimulation for three months resulted in significant improvement in global longitudinal tension, inflammatory cytokines, and quality of life. Our results support the emerging paradigm of noninvasive neuromodulation to treat selected heart failure patients with preserved ejection fraction and provide the basis for further randomized trials.

Parasym is the only company to have developed a device that uses advances in electroceutical technology to provide breakthrough non-invasive treatment for numerous health and wellness conditions ranging from mental health to physical health, including heart failure. heart, without the need for medication. For more information about Parasymvisit parasym.co.