Research and Clinical Trials at the GW Heart & Vascular Institute

Research and Clinical Trials at the GW Heart & Vascular Institute

RESPECT Clinical Trial
Stroke is the third leading cause of death among Americans, but nearly 40% of people who suffer a stroke have no known risk factors, such as high blood pressure and diabetes. The diagnosis for these patients is cryptogenic stroke, meaning stroke of an unknown origin or cause. Medical researchers have suspected for some time that cryptogenic stroke could be linked to a common heart defect, patent foramen ovale (PFO). Studies have shown that nearly half of people who suffer a cryptogenic stroke also have a PFO, a small hole between the upper chambers of the heart.

ELITE Study
The objective of this study is to show similar (non-inferior) safety and effectiveness between CYPHER® ELITE™ and CYPHER® Bx VELOCITY® Sirolimus-Eluting Stent Systems in a prospective, multi-center, randomized clinical study for the treatment of de novo native coronary lesions.

TRA2P Study
The study is designed to determine whether SCH 530348, when added to the existing standard of care for preventing heart attack and stroke (eg, aspirin, clopidogrel) in patients with a known history of atherosclerosis, will yield additional benefit over the existing standard of care without SCH 530348 in preventing heart attack and stroke. The study is also designed to assess risk of bleeding with SCH 530348 added to the standard of care versus the standard of care alone.

CABANA Trial
The CABANA Trial has the overall goal of establishing the appropriate roles for medical and ablative intervention for atrial fibrillation (AF). The CABANA Trial is designed to test the hypothesis that the treatment strategy of left atrial catheter ablation for the purpose of eliminating atrial fibrillation (AF) will be superior to current state-of-the-art therapy with either rate control or rhythm control drugs for reducing total mortality in patients with untreated or incompletely treated AF.

HESTIA Study
Evaluates the effects of dronedarone on Atrial Fibrillation (AF) burden (percent of time in which a subject is in AF) based on electrogram (EGM) data in subjects with a permanent pacemaker
It will also evaluate the effects of dronedarone on AF pattern characteristics: number of episodes, duration and ventricular rate during AF, evaluate the effects of dronedarone on subject-perceived AF burden and symptom severity as reported by subjects using the Atrial Fibrillation Severity Scale (AFSS), evaluate the incidence of electrical cardioversion or overdrive pacing during treatment and evaluate the safety of dronedarone.

VISTA-16 Study
The objective of this study is to evaluate the safety and efficacy of short-term A-002 treatment on morbidity and mortality when added to atorvastatin and standard of care in subjects with an acute coronary syndrome (ACS).

WARCEF Study
The purpose of this study is to determine which of two treatments, Warfarin or aspirin, is better for preventing death and stroke in patients with poor heart function.

dAL-HEART Study
dal-OUTCOMES is an ongoing Phase III mortality and morbidity study designed to evaluate the effect of dalcetrapib when added to existing standard of care in patients who have experienced a recent acute coronary syndrome event.

EMPHASIS Study
In an earlier study, eplerenone was shown to improve survival in patients who had heart failure immediately following a heart attack. However, it is not known how patients with established mild-to-moderate heart failure (NYHA Class II), who have the additional risk of sudden death, will respond if treated with eplerenone. In this trial, eplerenone plus standard heart failure medicines is being compared to placebo plus standard heart failure medicines in terms of an additional ability to prolong life and prevent re-hospitalizations for worsening heart failure in these patients.

ASTRONAUT Study
This study will evaluate the effect of early initiation of aliskiren therapy, compared to standard therapy, in the reduction of cardiovascular death and heart failure re-hospitalization events within 6 months, in congestive heart failure (CHF) patients hospitalized for an episode of acute decompensated heart failure.

STEP-DC Health Connect Chronic Care Initiative: Cell Phone Intervention
The Chartered Family Health Center presents the DC Health Connect program, an exciting cell phone based intervention project that aims to improve self-management behaviors in patients with diabetes in an effort to reduce emergency department visits and hospitalization. The DC Health Connect program builds on the existing model which consists of clinic-based healthcare providers and case managers and adds a cell-phone based application to ensure blood sugar control through self-monitoring, real-time feedback, coaching and support.

For more information www.clinicaltrials.gov.