Research Trials in the Center for Preventive Cardiology

SYMPLICITY HTN-3: Renal Denervation in Patients With Uncontrolled Hypertension

This study is looking for participants with high blood pressure (hypertension) that is not currently controlled. The purpose of this study is to provide additional information about an investigational device intended to help treat high blood pressure in patients whose blood pressure is not controlled, despite treatment with multiple blood pressure medications.

The kidneys are an important regulator of blood pressure.  Previous research has shown that disrupting the nerves of the kidney may successfully decrease blood pressure. An approach to disrupt these nerves is to apply brief high temperature near the nerves (renal denervation) using treatment with an investigational device, the Symplicity^® Catheter System™ (“study device”). This device delivers low-level radiofrequency (RF) energy through the wall of the blood vessel to the kidney (renal artery) to disrupt the nerves that lead to the kidney. The study device is not commercially available in the U.S.; it is considered an investigational device meaning it is not yet approved by the U.S. FDA.   

Participation in this study will last for a minimum of 3 years with at least 8 follow-up visits.

RenalGuard CIN-RG: A Study to Evaluate RenalGuard™ System Safety and Efficacy when Compared with Standard Care in the Prevention of Contrast Induced Nephropathy in the Setting of a Catheterization Laboratory

The RenalGuard CIN-RG study is recruiting patients with impaired kidney function who are scheduled to undergo a catheterization procedure that may involve a percutaneous coronary intervention (PCI).  These patients may be at a higher risk for developing contrast induced nephropathy (CIN), which is kidney damage caused by exposure to the contrast agent used during the catheterization procedure.  Physicians believe that CIN can lead to further medical problems both right after the catheterization and in the future.

The purpose of this study is to determine if a new treatment, called induced diuresis (increased urine production) with matched hydration, is a safe and potentially effective way to protect the  kidneys during catheterization procedures.  The way that induced diuresis and matched hydration therapy is accomplished is by making the kidneys produce more urine than usual, then matching the amount of urine produced by replacing it with the same volume of a standard, sterile salt solution (saline).  The saline is infused (given) via a small intravenous (IV) catheter (a small tube) that is placed into a vein in the arm.  It is believed that the therapy works by more rapidly flushing the contrast agent out of the body making the kidneys at lower risk for damage.  It is also believed that by replacing only the amount of fluid produced from the body during urination, potential side effects from either putting too much or not enough fluid into the body will be prevented.

At this time, the sponsor is conducting a study to show that induced diuresis with matched hydration using The RenalGuard System (“Study Device”) is better than the current treatment in the prevention of CIN.

The trial will enroll 326 subjects at up to 30 different hospitals.  This hospital expects to enroll approximately 10 to 15 subjects.  Participation in this study is expected to last up to 90 days after the catheterization procedure is performed.  .