Penn Heart and Vascular

Clinical Trials at the Heart Failure Program

Updated 12/16/2013

Outpatient Heart Failure Studies

Calcium Up-Regulation by Percutaneous Administration of Gene Therapy In Cardiac Disease Phase 2B (CUPID Phase 2b Trial)

This is a phase 2b, double-blind, randomized study of a single intracoronary administration of an AAV-linked gene therapy product (SERCA2a=MYDICAR, 1x1013) versus placebo added to an optimal HF regimen.

RESPICARDIA, Inc. Pivotal Trial of the Remede® System

This is a randomized trial evaluating the safety and effectiveness of the Remede system in patients with Central Sleep Apnea. The remede system is an implantable device that utilizes an implantable pulse generator (IPG) and up to 2 transvenous leads, 1 for unilateral stimulation of the subject's phrenic nerve and one optional lead to sense respiration via transthoracic impedance

Outpatient Studies

Working to Improve Discussions about Defibrillator Management (WISDOM)

This is a multicenter observational study of symptoms and quality of life in patients with ICDs and their caregivers.

Medical Arm of Mechanical Circulatory Support(MEDAMACS)

The objective is to prospectively identify a population of ambulatory patients on optimal therapy for whom chronic heart failure limits both function and survival to a range where elective VAD implantation would offer meaningful benefit. This is an observational registry of heart failure patients.

Promotion of Renal Sodium Excretion by Renal Sympathetic Denervation in Congestive Heart Failure (PRESERVE)

The purpose of the study is to improve renal sodium handling through Renal Sympathetic Denervation (RSD) in patients with symptomatic HF.

Heart Failure Inpatient Studies

Aquapheresis Versus Intravenous Diuretics and Hospitalizations for Heart Failure (AVOID-HF)

This is a multicenter, prospective, non-blinded trial. Randomization between IV loop diuretics and Aquapheresis will occur within 24 hours of admission and patients will be followed for 90 days after discharge.

Functional Impact of GLP–1 for Heart Failure Treatment(FIGHT)

This is a randomized, double-blinded, placebo-controlled study. High-risk patients with reduced ejection fraction and AHFS will be treated for six months post–discharge. May be enrolled within 2 weeks of discharge.

Promotion of Renal Sodium Excretion by Renal Sympathetic Denervation in Congestive Heart Failure (PRESERVE)

The purpose of the study is to improve renal sodium handling through Renal Sympathetic Denervation (RSD) in patients with symptomatic HF.

Post-Transplant Studies

Chronic Illness Management and Adherence in Transplantation (BRIGHT)

The study will describe non–adherence to medical regimen in heart transplantation (HT) and compare it across centers, as well as assess selected healthcare system factors potentially related to non-adherence.

Pediatric Heart Transplantation: Transitioning to Adult Care (TRANSIT)

The purpose of this 3 year study is to develop a transition program that may improve outcomes for young adults who underwent cardiac transplant as children as they transfer to adult care.

Cardiac Transplant Studies

Prevention of Cardiac Allograft Vasculopathy Using Rituximab (Rituxan®) Therapy in Cardiac Transplantation (CTOT-11)

The primary endpoint will be the nominal change from baseline to 1 year in percent atheroma volume (PAV) measured by IVUS in a target coronary artery.

A Prospective, Randomized, Multicenter, Two-Parallel Arm Study Evaluating the Overall Efficacy and Safety of Desensitization Therapy on Selected Patients Awaiting Heart Transplantation (CTOT–13)

The primary objective is to evaluate the safety and efficacy of desensitization therapy, which includes VELCADE® (bortexomib) and plasmapheresis, on select sensitized patients awaiting heart transplantation only.