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Format: 04/19/2014
Format: 04/19/2014


Allegheny General Hospital Researchers Launch Clinical Trial of Implanted Device for Congestive Heart Failure

Friday, March 12th, 2010

PITTSBURGH – Cardiovascular disease researchers at Allegheny General Hospital (AGH) are evaluating an implantable investigational device to determine if it can help patients suffering from diastolic heart failure, a life-threatening condition that currently has no cure or effective treatment options. 

Called the HOPE4HF trial, the study is testing the safety as well as the efficacy of the Rheos System, which works by electrically activating baroceptors, the body’s natural blood flow sensors that regulate cardiovascular function.

The Rheos System is also being investigated for patients with drug-resistant hypertension and preliminary results have demonstrated the device’s potential to significantly reduce blood pressure in these cases.

AGH is the only hospital in western Pennsylvania exploring the efficacy of the Rheos System in both the hypertension and heart failure studies.

“Though we have made significant strides in improving the health of patients who suffer from systolic heart failure, we have very few options for patients who suffer from diastolic heart failure. Unfortunately, about half of patients with congestive heart failure have diastolic heart failure, and for these patients our focus is on controlling risk factors such as hypertension, and coronary artery disease, and treating pulmonary congestion, rather than treating the disease,” said Srinivas Murali, MD, Director, AGH Division of Cardiovascular Medicine, and Medical Director, Gerald McGinnis Cardiovascular Institute

“In the absence of approved drugs or devices to treat this type of heart failure, the Rheos therapy offers hope that these patients can have improved quality of life, fewer hospitalizations and a lower risk of death,” Dr. Murali said.

About 5.7 million people in the United States have congestive heart failure, resulting in an estimated 300,000 deaths per year, according to the American Heart Association. The five-year mortality rate associated with the disease is nearly 75 percent.

With heart failure, the heart cannot pump enough blood to meet the body’s needs. Symptoms may include general fatigue or weakness, shortness of breath, and swelling in legs and ankles.

Diastolic heart failure interferes with the heart’s ability to relax, as opposed to systolic heart failure, which interferes with the heart’s ability to contract. This causes the heart to become stiff and thick, and prevents it from filling properly with blood.

Patients with diastolic heart failure are more likely to be elderly, female and obese. Their reduced functional capacity and exercise tolerance is similar to that of systolic heart failure patients; however two-thirds of them have hypertension and are prone to acute episodes of pulmonary edema requiring hospitalization.

Researchers expect to enroll 540 patients at up to 70 U.S. research sites and 20 international sites. The trial will measure whether the Rheos System provides the following benefits: reduction of heart failure symptoms, improvement in quality of life, extension of life expectancy, improvement of heart function, and reduction in the number of hospitalizations and emergency room visits.

The Rheos System is comprised of a small device that is implanted under the collar bone, two thin lead wires from it that connect to the left and right carotid arteries, and an external device that doctors use to noninvasively regulate the System.

When the Rheos System is activated, electronic signals are sent through neural pathways to the brain, which responds by telling the arteries to relax, the heart to slow down and relax and the kidneys to eliminate excess fluid in the body.

“As our population ages, diastolic heart failure will become increasingly common, heightening the need for effective treatment options for this disabling condition,” said Dr. Raymond Benza, MD, Director, Section of Heart Failure, Transplantation and Pulmonary Hypertension at AGH. “We are proud to enroll patients in this well-designed clinical trial that has the potential to help so many.”

In addition to Dr. Murali and Dr. Benza, other AGH doctors participating include.Dr. George Sokos, and Dr. Satish Muluk.

CVRx of Minneapolis developed the Rheos System for high blood pressure and heart failure. Data from the HOPE4HF trial are intended to support a Pre-Market Approval application to the U.S. Food and Drug Administration for use of the Rheos System in heart failure.

Patients interested in this trial can contact Sheila Bernardini by phone at 412-359-3281 or by email at sbernard@wpahs.org.



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