Research Study for Heart Failure Patients

Study Summary

The University of Chicago and Dr. Neeraj Jolly are conducting a research study for heart failure patients. Heart failure is a disorder that causes damage to the heart over a period of time. This damage makes it difficult for the heart to pump enough blood to meet the demands of the body. Heart failure is a progressive disease that often gets worse over time. Hypertension (high blood pressure) or coronary artery disease (blood vessels that supply blood to the heart are narrowed or occluded) are the most common causes of heart failure. This is a research study of an experimental device system developed for use in the medical management (helping your doctor decide what medications are best) of patients suffering from heart failure. The word "experimental" means the device system is still being tested and is not approved by the FDA (Food and Drug Administration). The purpose of this study is to evaluate the benefits of the use of the device system in the treatment of heart failure subjects in reducing hospitalizations related to the disease process. Doctors treating heart failure patients rely on signs and symptoms, physical exams, and lab work to manage heart failure therapy. In addition, special procedures are needed to evaluate the condition and performance of the heart. One of these procedures is a heart catheterization. During this procedure, pressures in the heart and the blood vessels close to the heart (pulmonary arteries) are measured using a Swan-Ganz catheter (a thin, flexible tube). A heart catheterization offers valuable information to the physician; however, it is limited to a one-time "snap-shot" of the pulmonary artery pressures related to heart function. The HF Pressure Measurement System may provide physicians with reliable, accurate daily trends of pulmonary artery pressure measurements. This system may prove valuable in the management of care for heart failure patients in preventing decompensation (worsening of symptoms) leading to hospitalizations. The device system consists of a sensor, delivery system, external electronics (antenna), and a home monitoring unit. The system will be used in your home to transmit your pulmonary artery pressure measurements to a secure website for your doctor to review and determine the best way to manage your disease based the information provided by the device system.

For the purposes of this study, you will be randomly assigned (like the flip of a coin) to one of two groups. One group will receive normal, routine medical care of heart failure management plus heart failure management based on information obtained from the experimental device system. The other group will receive normal, routine medical care of heart failure management without any information provided by the experimental device system.

You will be in this study for about thee years. Some of the procedures that will be done during this study are: physical exams, blood and urine testing, completion of questionnaires, a surgical procedure to implant the device with an overnight hospital stay. After the initial procedures, you will see a study doctor at 1month, three months, six months, and every six months until completion of the study.

Benefits

You may not receive any direct medical benefit from participating in this study. Your participation may provide information about the HF Pressure Measurement System that may benefit other heart failure patients in the future. There is a chance that the system may help your doctor manage your heart failure.

Participation Details

Initial selection criteria include:

• Must be at least 18 years of age
• Must not be pregnant
• Have been diagnosed with heart failure for greater than three months and have been classified as NYHA Class III
• Have experienced at least one hospitalization with in the past 12 months because of your heart failure
• Must meet study medical criteria as evaluated by Dr. Jolly

Study Director: Dr. Neeraj Jolly
Department: Cardiology

For more information contact:
Bridget Galetti
bgaletti@medicine.bsd.uchicago.edu
(773) 702-0347

IRB: #15802B