Clinical trials

The purpose of this study is to identify gene changes that cause DCM and gene differences that influence the development and severity of DCM. These genetic studies may identify a change in a gene that has already been linked with DCM, a change in a gene not previously associated with DCM, or these studies may identify a gene or genes that affect the development and severity of the DCM. With this knowledge we hope to have a better understanding of how genes and gene changes cause DCM.

There are two equally important primary hypotheses, which will be tested in two independent parallel, randomized clinical trials.

One trial will test the primary hypothesis that intensive medical management differs from the combination of CEA and intensive medical management in preventing the primary endpoint in patients with high-grade asymptomatic carotid stenosis.

One trial will test the primary hypothesis that intensive medical management differs from the combination of CAS and intensive medical management in preventing the primary endpoint in patients with high-grade asymptomatic carotid stenosis.

In both trials, the primary endpoint is stroke or death within 44 days after randomization or ipsilateral ischemic stroke thereafter at the 4-year time point of follow-up.

C-TRACT is a large, well-designed study of new treatments for vein damage caused by blood clots. The goal of the study is to understand whether new image-guided procedures (endovascular therapy or EVT) reduce the severity of Post-Thrombotic Syndrome (PTS) and improve quality of life. The long-term safety and costs of the EVT procedure(s) will also be considered. Volunteers will be randomly assigned (like the flip of a coin) to either high quality PTS care (lifestyle interventions, compression therapy, and medical therapy) or high quality PTS care AND endovascular therapy (stent placement to re-open blocked veins and, if needed, endovenous ablation to eliminate backflow in veins with leaky valves). After randomization, patients will be asked to return to their clinical research center for study visits at 2 Months, 4 Months, 6 Months, 12 Months, 18 Months, and 24 Months.

This research study is designed to better understand the molecular determinants of response to immunotherapies including pembrolizumab and nivolumab. We hope to learn the relevance of tumor neoantigens in the recognition of cancer cells by the immune system. The ultimate goal is to rank and filter these neoantigens and correlate with response to immunotherapies.

Mitral valvular disease, and specifically mitral valve regurgitation is the most common valve disease in the US. Currently mitral valve surgery (open heart surgery), either with repair or replacement, is the standard of care for patients with symptomatic mitral valve disease. Transcatheter mitral valve replacement (TMVR) is an emerging therapy that could offer patient a less invasive alternative to open heart surgery. The goal of the APOLLO trial is to evaluate whether TMVR is non-inferior to conventional mitral surgery with respect to composite endpoint rate of all-cause mortality, all stroke, reoperation (or reintervention) and cardiovascular hospitalization at one year in patients with severe symptomatic native mitral regurgitation. The secondary objectives of this trial are to assess differences in quality of life, clinical benefit (efficacy endpoints) and health economics in patients with severe symptomatic native mitral regurgitation.

The field of Cardiology has made tremendous strides to reduce cardiovascular (CV) disease over the past several decades through reduction of risk factors and novel medical treatment to manage disease once present. However, much work is still needed to combat CVD. At the Inova Heart and Vascular Institute we are collecting biological samples from patients undergoing cardiac catheterization for genomic, biochemical, molecular and cellular analyses. It is hoped that future analyses on these samples will help us learn what factors predispose patients to develop cardiovascular disease, cause progression of symptoms and/or predict response to various therapies. Our ultimate goal is to be able to predict long-term clinical outcomes in patients who are living with cardiovascular disease to further reduce the incidence, morbidity and mortality rates of CVD.