Clinical Trials

Team tests innovative heart failure therapy in global clinical trials

Team tests innovative heart failure therapy in global clinical trials

Team tests innovative heart failure therapy in global clinical trials

 

 

Team tests innovative heart failure therapy in global clinical trials

 

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Home Infusion Therapy is a more convenient and cost-effective option than traditional inpatient therapy, with care administered in the comfortable surroundings of one’s own home. Home Infusion Therapy allows for a more active role in one’s own health care. It can also ease stress and anxiety that is sometimes associated with inpatient treatment, resulting in better patient outcomes.

 

 

A multidisciplinary team of experts in heart failure, cardiac arrhythmia, and neurosurgery at The Mount Sinai Hospital are now testing nerve stimulation in the neck as a novel therapy for heart failure patients to potentially help relieve their debilitating symptoms of fatigue, shortness of breath, and heart arrhythmias, while reducing their hospitalizations.

 

The global, multicenter randomized clinical trial called INOVATE-HF (INcrease Of VAgal TonE in chronic Heart Failure) is investigating the safety and efficacy of an implantable vagus nerve electrical stimulation device called CardioFit- to improve the heart’s function and the quality of life of heart failure patients.

 

Mount Sinai’s multidisciplinary team of clinical trial investigators includes principal investigator electrophysiologist Vivek Reddy, MD, Director of Arrhythmia Services; neurosurgeon Brian H. Kopell, MD, Director of the Center for Neuromodulation; and heart failure specialist Ajith P. Nair, MD, Director of the Pulmonary Hypertension Program in the Advanced Heart Failure and Transplantation Program.

 

The device is a three-part system consisting of a “stimulator” about the size of a pacemaker, and two connecting leads. The stimulator is implanted under the skin of the chest with a “sensor lead” implanted inside the right ventricle of the heart, and a “stimulation lead” implanted around the vagus nerve in the right side of the neck.

 

The large vagus nerve runs from the brain stem down to the abdomen on both the left and right side of the body. It sends signals throughout the body and directly to and from the brain to regulate multiple bodily functions including heart rate.

 

Once activated by doctors, the stimulator in the chest sends mild electrical pulses up to the vagus nerve to help reduce heart rate, stress, and workload on the cardiac muscle to improve overall heart function. The sensor lead in the heart’s right ventricle monitors for any abnormal changes in the heart’s electrical activity and provides feedback to the stimulator enabling it to react.

 

“This novel use of vagus nerve stimulation may be the therapy we have long been waiting for to bring relief to heart failure patients with chronic symptoms and protect them from dangerous and potentially fatal arrhythmias,” says Dr. Vivek Reddy, Director of Arrhythmia Services at The Mount Sinai Hospital. “The results of this study testing the simple electrical stimulation of the body’s powerful vagus nerve may unlock a future promising therapy for heart failure. I am excited that by working with our heart failure and neurosurgery colleagues, we can offer this potentially transformative therapy to our patients.”

 

“Our clinical trial will compare the benefits of vagus nerve stimulation to the standard treatment of combination medication which is currently our first line of defense against heart failure,” says Dr. Ajith P. Nair, Director of the Pulmonary Hypertension Program in the Advanced Heart Failure and Transplantation Program at The Mount Sinai Hospital. “Our study will also test vagus nerve stimulation therapy’s ability to reduce hospitalization, a major issue for heart failure patients, as well as, its capability to reduce mortality in this high-risk population.”

 

“At Mount Sinai we have successfully used vagus nerve stimulation for refractory epilepsy in patients with uncontrollable seizures, and to treat patients with major depression, who don’t have good responses to medication therapy,” says Dr. Brian H. Kopell, Director of the Center for Neuromodulation at The Mount Sinai Hospital. “This trial represents the first time VNS is being tested in heart failure patients in the United States. We are excited to see what clinical benefits are possible and hope this innovative therapy may bring relief to patients at Mount Sinai and around the world suffering from heart failure.”

 

Recent international studies investigating the CardioFit- device have shown that patients with the nerve stimulation device can experience sustained improvement in heart function and structure, heart rate, improvement in quality of life, and increased exercise tolerance. Research shows patients may start to experience improvement in their heart failure symptoms after several weeks and months of gradually increased nerve stimulation therapy.

 

Heart failure affects more than six million people in the United States and 23 million worldwide. It occurs when a person’s heart is too weak to properly pump and circulate blood throughout their body. A single or several conditions over time can increase a person’s risk of developing heart failure by weakening their heart muscle or damaging their heart’s vessels including arrhythmias, which are abnormal electrical heart rhythm disturbances affecting the heart’s proper beating.

 

Patients eligible for enrollment in the INOVATE-HF clinical trial are those diagnosed with New York Heart Association stage III “moderate” heart failure, who even though they are being treated with several combination medications, they continue to have debilitating symptoms including fatigue, shortness of breath, and abnormal heart arrhythmias.

 

 

Originally Posted: News-medical.net

 

Implantable Device Designed to Treat Congestive Heart Failure

Implantable Device Designed to Treat Congestive Heart Failure

Implantable Device Designed to Treat Congestive Heart Failure

 

Implantable Device Designed to Treat Congestive Heart Failure

 

NBN Infusions delivers comprehensive services to patients of all ages, from pediatric to geriatric, providing a full range of care for Home Infusion Therapy. NBN Infusions on-site, licensed pharmacy can provide prescription medications, equipment, supplies and skilled nursing care needed for Home Infusion Therapy.

Home Infusion Therapy is a more convenient and cost-effective option than traditional inpatient therapy, with care administered in the comfortable surroundings of one’s own home. Home Infusion Therapy allows for a more active role in one’s own health care. It can also ease stress and anxiety that is sometimes associated with inpatient treatment, resulting in better patient outcomes.

 

Allegheny General Hospital (AGH), an affiliate of the Allegheny Health Network, is enrolling patients in a landmark clinical trial to explore the use of a promising investigational technology designed to treat congestive heart failure by stimulating the body’s natural mechanism for blood pressure regulation.

 

The Barostim HOPE4HF clinical trial will evaluate the effectiveness and safety of Barostim neo, a second generation implantable device that electrically activates the baroreceptors, the body’s natural blood pressure sensors that regulate heart function. The system is designed to signal the brain to relax the arteries to facilitate blood flow, slow the heart allowing more time for it to fill with blood, and prompt the kidneys to reduce fluid in the body, reducing the heart’s workload. This, in turn, is designed to improve heart function and reduce heart failure symptoms.

 

“Barostim Therapy initially was studied in more than 500 patients with excellent results,” said Srinivas Murali, MD, Director of Allegheny General’s Division of Cardiovascular Medicine and Medical Director of the hospital’s Cardiovascular Institute. “With a new system that’s smaller and more easily placed, we hope to see even further improved patient outcomes.”

 

Perfecting a device that can help the heart work more efficiently would be an important advance for the 5.1 million adults living with heart failure in the US. Statistics show that 670,000 new cases are diagnosed each year and more than 277,000 people die annually of the disease. In western Pennsylvania and in the rest of the country, heart failure is the leading cause of hospitalization for those over the age of 65.

 

In heart failure, the heart cannot pump enough blood to support the body. Impaired heart function results in shortness of breath, exercise intolerance and fluid retention. Those with heart failure are six to nine times more likely to experience sudden cardiac death than their healthy counterparts.

 

Barostim neo is a pacemaker-like device consisting of two parts: a small pulse generator implanted under the collar bone which is connected by a think wire to a small lead implanted unilaterally either on the left or the right carotid artery. An external programmer is used by doctors to non-invasively transmit and regulate energy from the generator to the small lead.

 

Barostim neo is adjustable to each patient’s unique needs. The device operates automatically and continuously, eliminating the possibility of noncompliance with treatment recommendations.

 

Barostim neo was developed by CVRx, Inc., a privately held company based in Minneapolis.

 

The device achieved promising clinical results in European studies. AGH and a handful of other elite US medical centers will be enrolling up to sixty patients in the American study.

 

To enroll, patients must have a left ventricular ejection fraction less than or equal to 35 percent and be classified as having New York Heart Association Class III Heart Failure.

 

For more information on the study, contact Sheila Bernardini, RN, Research Coordinator, at 412-359-3281or sbernard(at)wpahs(dot)org or visit the study website at http://www.HeartfailureTrial.com.

 

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About AGH Cardiovascular Institute: Allegheny General Hospital’s Cardiovascular Institute offers comprehensive, state-of-the-art care for the complete spectrum of cardiovascular disease. The Institute’s nationally recognized medical staff includes specialists in general and interventional cardiology, electrophysiology, leading edge diagnostic cardiology – including cardiovascular MRI, CT and 3-D echocardiography – women’s heart care, heart failure and pulmonary hypertension, heart transplantation and mechanical circulatory support, vascular surgery and wound care, thoracic surgery, heart valve disease and coronary artery bypass surgery.

 

The hospital’s broad scope of advanced capabilities in the treatment of heart failure offers patients access to cutting edge investigational therapies being explored in clinical trials, such as new medicines and implantable devices designed to more effectively monitor disease progression and treat conditions before they require hospitalization.

 

About the Allegheny Health Network:

 

Allegheny Health Network is an integrated healthcare delivery system serving the Western Pennsylvania region. The Network is comprised of eight hospitals, including its flagship academic medical center Allegheny General Hospital, Allegheny Valley Hospital, Canonsburg Hospital, Forbes Hospital, Jefferson Hospital, Saint Vincent Hospital, Westfield Memorial Hospital and West Penn Hospital; the Allegheny-Singer Research Institute; a soon-to open medical mall; and a healthcare group purchasing organization. The Network employs approximately 17,000 people, including more than 2,100 physicians on its medical staff. The Network also serves as a clinical campus for both Temple University School of Medicine and Drexel University College of Medicine.

 

Read the full story at: HispanicBusiness.com 

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