Release Date: 05/08/2015
Care New England Cardiovascular Care has announced it is taking part in the TEMPO clinical research trial. The research will evaluate the effect of an investigational drug being developed for the treatment of heart rhythm problems. The study is specific to patients with Implantable Cardioverter-Defibrillators (ICD) or Cardiac Resynchronization Therapy-Defibrillators (CRT-D).
The purpose of the TEMPO study is to assure what effect the trial drug has on heart rhythm problems in patients who have an ICD or CRT-D, and also determine the safety profile of the drug in this phase II study.
Specific heart rhythm problems which the investigational drug is being developed for are ventricular tachycardia (VT) and ventricular fibrillation (VF), in patients with an ICD or CRT-D. VT and VF are major causes of sudden death relating to the heart. Patients who have a history of these conditions or are at risk for developing these conditions, are usually treated with an ICD which can stop VT/VF but does not prevent VT/VF. The drug may also be beneficial for potential defibrillator shocks which can be painful and psychologically traumatic to the patient.
“We are excited to be conducting the TEMPO clinical trial for the many patients who have heart rhythm problems and live with ICD and CRT-D devices,” says Chester Hedgepeth, MD, PhD, executive chief of cardiology, Care New England. “These patients could greatly benefit from drug therapy to reduce the frequency of VT/VF and defibrillator shocks.”
Enrollment will occur over a 12-month period and the expected maximum treatment duration is approximately 18 months. Approximately 120 subjects will be randomized at about 120 study sites in North America, Europe and Israel. The study is open to male and female subjects, 18-80 years of age and is funded by Gilead Sciences, Inc.
For more information on this study or to find out if you qualify for enrollment, please call (401) 681-4996.
From outpatient consultation, to treatment in a congestive heart failure clinic, to counseling for a heart transplant, Care New England Cardiovascular Care is structured to care for you from diagnosis to treatment. With specialists from Brigham and Women's Cardiovascular Associates at Care New England, patients are provided with a broad spectrum of cardiac services, with a personalized approach.
Services are provided at convenient locations throughout the state including Kent, Memorial and Women & Infants hospitals, as well as Garden City in Cranston. Services include advanced cardiovascular imaging modalities such as cardiac CT, an advanced valvular heart disease service, and advanced heart failure service with transplant consultation. In addition to the array of advanced services, outpatient consultations and stress testing, cardiac catheterization and heart failure clinic nursing support are available. There is also access to cardiovascular clinical trials, a cardiac telemedicine program and congestive heart failure management program and a full range of cardiac arrhythmia services. Also, when appropriate, doctors can quickly arrange for the most advanced, world-class care at Brigham and Women’s Hospital in Boston, with follow-up care back home. For more information, please visit carenewengland.org/cardiology.