Penn Heart and Vascular

Clinical Trials at the Ventricular-Assist Device Program

Clinical Trials

Outpatient Heart Failure Studies

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

Nitrate's Effect on Activity Tolerance in Heart Failure with Preserved Ejection Fraction (Neat-HFpEF)

A randomized, double-blinded, placebo-controlled crossover study to assess effect of isosorbide mononitrate with dose up-titration on activity tolerance as assessed by (hip-worn, tri-axial) accelerometry.

Oral Iron Repletion effect On Oxygen Up Take in Heart Failure ( IRONOUT-HF)

The purpose of this study is to determine if oral iron (FE) polysaccharide is superior to oral placebo in improving functional capacity as measured by change in peak VO2 by CPET (Cardiopulmonary Exercise Testing), of a broad population of patients with HFrEF (Heart Failure Exercise Testing) and Fe deficiency at 16 weeks.

Pulmonary Hypertension

An Open- Label Extension Study of UT-15C in Subjects with Pulmonary Arterial Hypertension- A Long-Term Follow-UP to Protocol TDE-PH-310 (UT-310)

This study is an international, multi-center, open-label study designed to provide oral treprostinil (UT-15C) to eligible subjects with pulmonary arterial hypertension who have completed the TDE-PH-310 study. The purpose of this study is to assess the long-term safety of UT-15C and to assess the effects of long-term treatment with UT-15C on exercise capacity.

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.

A Phase lla, single-Bind, Placebo-Controlled, Crossover, Multi-Center, Randomized to Assess the Safety, Tolerability, and Preliminary, and Preliminary Efficacy of a Single Intravenous Dose of Ischemia-Tolerant Allogeneic Mesenchymal Bone Marrow Cells to Subjects with Heart Failure of Non-Ischemic Etiology

Heart Failure Genomics Studies

HCMR Novel Predictors of Outcome in Hypertrophic Cardiomyopathy

Hypertrophic cardiomyopathy (HCM) is the most common monogenic heart disease (prevalence 1 in 500) and the most frequent cause of sudden cardiac death (SCD) in the young. While the majority of patients remain asymptomatic, prognosis is poor in a subset who present with SCD or progress to heart failure (HF).

Penn Familial Cardiomyopathy Study Protocol

The purpose of this study is to try to find and understand the genes that cause cardiomyopathy in families. Illnesses such as cardiomyopathy that occur in families suggest that a faulty gene may be the cause. A gene is a segment of DNA that contains chemical instructions for how each person grows and develops. Genes are passed from parents to children and sometimes an error in a gene can lead to a health problem like cardiomyopathy

Dilated Cardiomyopathy Research Project Protocol

We are collaborating with Dr. Ray Hershberger from The Ohio State University in the Dilated Cardiomyopathy (DCM) Research Project, a family-based study aimed at identifying the genes responsible for DCM. Ours is one of several sites who form part of the DCM Research Consortium, a multi-institutional project consisting of several collaborating sites with The Ohio State University acting as coordinating center.

Heart Failure Inpatient Studies

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.

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.

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