Why we Conduct Clinical Trials
Cardiovascular disease is by far the most important health problem in the United States. Participation in clinical trials not only helps the development of new medicines and devices for the community as a whole but also helps the individual patient participating in each trial. This is only one reason that, at Stern Cardiovascular, participation in clinical trials is valued.
Our Current Clinical Trials
Studies Recruiting Patients
- EMPEROR: Cardiovascular safety trials for Jardiance (approved treatment for type 2 diabetes) demonstrated a 38% reduction in cardiovascular death. The EMPEROR clinical trial is comparing Jardiance versus placebo in patients with chronic HF and reduced or preserved ejection fraction. Patients do not have to be diabetic to participate.
- IMPROVE RESPONSE: This clinical trial was created by Dr. Eric Johnson, Dr. Frank McGrew, and Dr. Mark Coppess, to utilize the Adaptive CRT programming in patient that fail to respond to CRT therapy. About 33% of patients that receive a CRT device fail to improve their heart failure symptoms. We are recruiting subjects undergoing CRT generator replacement that have failed to respond to CRT therapy.
- GALACTIC: Omecamtiv mecarbil, the investigational study drug in GALACTIC, is designed to improve cardiac muscle performance and improve quality of life for patients with heart failure. This study is recruiting patients with EF ≤ 35% and NYHA II to IV.
Studies Coming to a Close
- WRAP-IT: The Wrap-It study with Dr. Eric Johnson enrolled 45 patients to evaluate the ability of the TYRX envelope to reduce infections in patients post generation replacement.
- REDUCE-IT: This study evaluated the effect of Vascepa (icosapent ethyl) for preventing cardiovascular death, MI, stroke, and coronary revascularization in patients with hypertriglyceridemia. Stern enrolled more than 30 patients into this study with Dr. Frank McGrew, and we look forward to receiving the results of the trial.
Why Should I Participate in Medical Research Study?
For many years, medical advances were made merely by physician investigators reporting their experience with different therapies. This was reasonably successful in a time where the scientific method was difficult to apply because so many of the medical sciences were so inexact and basic science theories about the true mechanisms of disease were unavailable. In the modern era, it has become apparent that for most therapies to have proven efficacies they need to be studied in well-designed clinical trials. These trials usually involve comparing a new medicine or procedure to existing therapy. Often, when medicines are involved, these trials involve the use of an inactive pill, or placebo, to be given to part of the patients in a clinical trial. This is necessary because many patients will benefit psychologically from any medicine and will have improved clinical result, which may mask the true benefit, or harm the new medicine being studied. This has been well shown in numerous cardiology studies over the last 10 years where different types of heart medicines to treat congestive heart failure and heart rhythm irregularities were shown to be actually harmful. In these trials, patients receiving the placebo actually faired better than those receiving the investigational medicines. Because of these observations, the Food and Drug Administration, prior to approving new medicines for use in the general medical community, almost always requires these trials where a new medicine is compared to a placebo.
These are the only ways to truly test the efficacy and safety of new medications. For example, many trials show that patients in the placebo group will often have side effects equal to those receiving the active medication. This is particularly common for "nuisance" side effects such as insomnia, headache, mild gastrointestinal upset, etc.
Patients with serious diseases almost always benefit from participating in these well-designed clinical trials for numerous reasons. In general, if the patient participates in the trial it is because he/she has a condition for which better therapies are needed and conventional therapies are not totally satisfactory. As a general rule, the physicians participating in these trials are those with extensive knowledge in that specific disease state as proven by their selection to run these trials. Patients in these trials are carefully followed by the clinical team of the research center and receive extra care and lab work, which will enhance their care during the conduct of a trial. Many studies have shown that patients receiving even the placebo in the clinical trial fair better than their counterparts receiving standard care within the community.
Our clinical trials have focused on several areas within cardiovascular disease. Our largest experience in treating patients with heart muscle weakness often manifests as congestive heart failure. Many patients with this disease will have a mortality rate each year in excess of 10% when receiving conventional therapy. We have several ongoing trials looking at new medications which are added to conventional therapy in hopes of reducing complications due to progressive heart muscle weakness, cardiac rhythm irregularities, and other consequences of congestive heart failure. These involve medications that block excessive spasm of the arteries within the body, block excessive inflammatory response, and drugs and implantable devices that block catastrophic unpredictable heart rhythm irregularities.
Heart muscle weakness is such a serious disease that most patients will benefit from being in these clinical trials. Another area of research involves patients with heart attacks treated with emergency use of balloons (angioplasty) or intravenously administered enzymes known as "clot busters". Although these are relatively successful state of the art therapies, they still leave some patients with extensive heart muscle damage. We are investigating the use of several additional treatments such as hormonal infusions during the acute phase of heart attacks as well as antibodies which block and excessive white blood cell inflammation of the area of heart attack.