Clinical research trials are an important aid in advancing understanding of the cardiac disease process, and in developing better treatments. They allow patients access to leading-edge therapies which might otherwise not be available for many years.
Many important studies are currently underway in the UNC Cardiac Catheterization Laboratory and in the UNC Heart Failure program. Both offer clinical trials that allow access to novel investigational procedures with potentially promising new treatment options.
Through the years, the UNC cardiac catheterization laboratory has been part of studies looking at new intracoronary stent designs, novel devices to treat coronary artery disease, and new drugs used in coronary artery disease treatment. UNC is also one of the few sites in North Carolina to participate in studies sponsored by the National Institutes of Health to determine the best treatments for blockages in the renal arteries (renal artery stenosis) and for damaged hearts (cardiomyopathy).
Heart failure remains a very challenging therapeutic area, with many patients still experiencing poor outcomes. UNC has conducted extensive clinical trial research in heart failure for over 25 years. Continued research for novel therapeutic approaches is ongoing so that better success can be achieved with patients in the near- and long-term future.
Much of the effort at UNC has focused on drug development, with over 100 clinical studies performed to date, including trials addressing agents in all major classes of drugs for heart failure treatment. Collaboration with the UNC School of Pharmacy for over two decades has been very positive for our drug development work. The program is well-positioned for ongoing therapeutic research efforts, as we have played a major leadership role in many clinical studies, and have been involved in all aspects of such studies, including design, conduct, analysis, and publication.
Recent efforts at UNC have involved the search for novel agents for the treatment of acute heart failure syndromes. Ongoing research is better defining peripartum cardiomyopathy syndrome. And new studies with our colleagues in cardiothoracic surgery related to transplantation and left ventricular assist devices have further enhanced the clinical research program at UNC.
Lastly, it is common in clinical research trials for patients to receive the new drug or device free of charge. Thus, clinical research trials can be beneficial in many ways to patients with financial hardships.
For information on active studies in the UNC Heart Failure Program, contact Amanda Lee.
If your physician has determined that you have an abnormal heart rhythm called atrial fibrillation that requires treatment, you may qualify for the CABANA Study at the University of North Carolina.
The CABANA Study will enroll and follow 3,000 patients like you, with atrial fibrillation, over the next five years. Patients who participate in the CABANA trial will receive close follow up by the health care team, and will have extra opportunities to report their symptoms and monitor their heart rhythm compared to most patients being treated for atrial fibrillation.
As a participant in the CABANA study, you will be randomly assigned to either the drug therapy treatment group or the ablation therapy treatment group. Whichever treatment group you are assigned to, you will receive the standard therapy for your arrhythmia as you would otherwise receive outside the study, if you and your doctor had independently chosen that treatment strategy. All CABANA participants will be provided with a single ‘CABANA Box’ recording system to be used for periodic monitoring of your heart rhythm during the follow-up period of the study. Individuals who participate in this study will receive closer follow-up of their heart rhythm using the ‘CABANA Box’ compared to most individuals treated outside of the study. At the end of the study, the information will be analyzed, and the best treatment will be determined.
If you recently had a heart attack and have decreased heart function as a result, you may qualify to be part of the Vest Prevention of early Sudden Death Trial (VEST) at the University of North Carolina.
In general, patients in this situation are at some risk for abnormal heart beats that can cause death, although it is not possible to tell exactly who will have such problems and how they can be prevented.
During this three month VEST study, the purpose is to find out whether wearing a defibrillator (a device that can shock the heart back to a normal rhythm) can prevent death from an abnormal heart rhythm in the three months after a heart attack. This wearable defibrillator is called a LifeVest.
At the end of the 3 month VEST study, you will enter into a Registry. The purpose of the VEST Registry is to collect and analyze data regarding your current disease or condition over a period of time to determine long term results.
A total of approximately 1900 people will take part in this study globally, including up to 100 people from this institution.
Study Title: A 52 Week, Phase 3 Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety and Tolerability of PF-04950615 in Subjects With Heterozygous Familial Hypercholesterolemia (Protocol #B1481021)
If you have high cholesterol (a type of fat in your blood) and a family history and/or symptoms or a positive genetic test that indicates you have a possible or definite diagnosis of heterozygous familial hypercholesterolemia, you may qualify to be part of the PCSK-9 clinical trial at the University of North Carolina.
The purpose of this research study is to compare the effects of the study drug, PF-04950615, with a placebo (inactive substance) to find out if the study drug will be effective in lowering levels of cholesterol in people with heterozygous familial hypercholesterolemia who are already taking a high dose of a certain statins and are at high or very high risk of cardiovascular problems (eg heart attack, stroke) but have not reached their target cholesterol level.
There will be about 300 people enrolled in this study. The study is being done at about 65 different research sites in about 11 countries. About 20 people will be enrolled at this site. You will be in this study for approximately 64 weeks (15 months). There will be up to approximately a 4 week screening period, 52 weeks of treatment and an 8 week follow up period. You will need to visit the research site at least 12 times during the study.