The Central Minnesota Heart Center Research Department opens new clinical trials on a regular basis. For information on these or additional studies that may be open and available to treat, control or prevent heart disease, please contact the research department at (320) 251-2700, ext. 57584 or e-mail wipperj@centracare.com.

A sample of cardiovascular research trials currently open to enrollment at the Central Minnesota Heart Center is listed below.

Prevention Trials

Tecos Study - The purpose of this study is to test the safety and effectiveness of Sitagliptin (trade name JANUVIA™) in patients with Type 2 Diabetes with a history of cardiovascular disease. Sitagliptin is an FDA approved drug available by prescription for control of blood sugar for those with Type 2 Diabetes. Patients will be randomized to receive either Sitagliptin or Placebo in addition to their normal standard of care. The dose of Sitagliptin (100 mg or 50 mg) will be determined by the patients kidney function and may be adjusted. Patients will return for study visits at Month 4, Month 8, Month 12, and then every six months until the end of study visit. Patient may be in the study up to 6 years. Principal Investigator: Bernard Erickson, MD

DAPT Study - The purpose of this study is to assess the effectiveness and safety of 12 versus 30 months of dual antiplatelet therapy (DAPT) in subjects undergoing percutaneous coronary intervention (PCI). Subjects may be enrolled into the study either before or after the index procedure. Enrollment can occur up to 24 hours post procedure. All enrolled subjects will be treated with either a drug eluting or bare metal stent and assigned to 12 months of open label DAPT treatment in addition to aspirin. All enrolled subjects who are considered “12 Month Clear” are eligible for randomization to either placebo or an additional 18 months of DAPT treatment. Both arms will continue with aspirin therapy. “12 Month Clear” is defined as subjects who are event free (from all death, MI, stroke, repeat coronary revascularization, stent thrombosis and major bleed). Follow-up will consist of telephone and clinic visits for 18 months followed by an additional 3 month observational period. Principal Investigator: Bernard Erickson, MD

IMPROVE-IT - The purpose of this study is to evaluate the clinical benefit of Ezetimibe/Simvastatin (Vytorin) compared with Simvastatin (Zocor) in stabilized acute coronary syndrome patients. Clinical benefits are defined as the reduction in the risk of the occurrence of the composite endpoint of CV death, major coronary events, and non-fatal stroke. The overall study length is anticipated to last 2 ½ - 5 years. Subjects will be seen in follow-up at 1 month, 4 months and every 4 months, thereafter. Principal Investigator: Bernard Erickson, MD

PRECISION Study - The purpose of this study is to assess the effects of celecoxib (CELEBREX) when compared to traditional (non-selective) nonsteroidal anti-inflammatory drugs on cardiovascular events, gastrointestinal events, renal events and symptomatic benefits in subjects with osteoarthritis or rheumatoid arthritis with cardiovascular disease or at high risk for developing CVD. Patients will be randomized to receive one of three sets of the following study drugs: celecoxib, ibuprofen, or naproxen. The testing of celecoxib compared to ibuprofen, or naproxen is investigational. The overall study length is anticipated to last 36 – 42 months. Principal Investigator: Bernard Erickson, MD

Roche NC20971 - The primary objective of this study is to evaluate the potential of RO4607381 (study drug) to see if it will reduce the risk of death from cardiovascular disease or having a cardiovascular event such as myocardial infarction (heart attack), stroke (brain attack), revascularization procedures (angioplasty, implanting a stent) or hospitalization for acute coronary syndrome (chest pain not associated with physical exertion and electrocardiogram [ECG] abnormalities) Patients will be randomized to receive either the study drug or placebo in a 1:1 ratio. Approximately 15,600 patients will be enrolled in this trial. Patients will be followed for a minimum of 2 years and possibly up to 5 years. During the first year of the treatment period, patients will be seen in the clinic at 1 month and 3 months after randomization and every 3 months thereafter. During the remaining years patients will be seen in clinic every 4 months until study completion. Principal Investigator: Bernard Erickson, MD

Tracer Study - This research study involves the use of an investigational drug, SCH 530348 (the study drug). The purpose of this research study is to evaluate the clinical benefit of the study drug and how it may reduce the complications related to coronary events when given to patients with a history of chest pain. Approximately 10,000 patients at 800 centers will be enrolled. Patients will be followed at 30 days, 4, 8, and 12 months; and then every 6 months thereafter until the end of the study. Principal Investigator: Bernard Erickson, MD

Heart Failure Trials

EXACT-HF - The purpose of this study is to determine if allopurinol, taken once a day, will benefit patients with chronic heart failure and elevated serum uric acid levels. Allopurinol is approved by the FDA and has been used for many years in the treatment of gout. Recent studies suggest that allopurinol may also improve symptoms and exercise capacity in patients with heart failure by lowering their uric acid levels. The use of allopurinol for heart failure is considered investigational. This is a randomized, double-blind study that will involve approximately 250 subjects. These subjects will be followed for up to 6 months. Principal Investigator: Tim Schuchard, MD

CARRESS-HF - The purpose of this study is to test if ultrafiltration compared to stepped pharmacologic care will result in improved renal function and relief of congestion in patients hospitalized with acute decompensated heart failure (ADHF) and cardiorenal syndrome. Subjects will be followed through the duration of their hospitalization and will also be asked to return to the clinic at 30 days and 60 days after enrollment. Principal Investigator: Tim Schuchard, MD

Intervention Trials

CloSys - The purpose of this study if to evaluate the safety and efficacy of the CloSys Hemostasis Device (HD) as an adjunct to standard compression in achieving Hemostasis at the femoral access site. Medical devices are commonly used to stop bleeding at the access-site. The CloSys HD is different from other medical devices in that is does not use mechanical closure or drugs to stop bleeding at the access site. CloSys HD removes Heparin from a small amount blood at the access-site in the groin. The device then inserts the de-heparinized blood back into the access-site allowing the body’s natural clotting system to take over and stop the bleeding. A key advantage of the CloSys HD is that it can be used immediately post procedure; unlike standard compression, which requires a lengthy wait period for the ACT level to decline to appropriate levels. The study is expected to enroll 130 patients at up to 10 hospitals across the United States. Patients will be followed for 30 days post-procedure to collect necessary study data and assess any adverse events. Principal Investigator: Bernard Erickson, MD

Premium - The objective of this study is to evaluate whether percutaneous PFO closure is effective in reducing the incidence of disabling migraine headaches in subjects. The purpose will be evaluated by investigating whether subjects who have their PFO closed experience a significant reduction in migraines over a 12 month period compared to those who were randomized to the sham procedure. The PREMIUM Trial will enroll at total of 230 subjects at up to 45 institutions. All subjects will be followed from the time of consent until discontinuation or completion of all study requirements. Subjects enrolled in the study will be evaluated at baseline, pre-discharge, 1, 4, 6, 8, 10, 11 and 12 months. Principal Investigator: Jacob Dutcher, MD

Sapphire-WW - This study utilizes the Cordis PRECISE® Nitinol Stent Systems, the Cordis ANGIOGUARD™ XP/RX Emboli Capture Guidewire and next generation Cordis carotid stents and EPDs as they become commercially available. The study population will consist of high-surgical risk patients with atherosclerotic disease of the carotid artery(ies). Subjects will be seen in follow-up at 30 days and have a telephonic interview conducted a 12 months to establish the occurrence of any major adverse events. The study is expected to enroll 10,000 patients at 350 sites. Principal Investigator: Bernard Erickson, MD

Device/Electrophysiology Trials

Adaptive-CRT - The purpose of this study is to test an investigational feature, called Adaptive CRT (aCRT) that attempts to automatically optimize CRT in patients with CRT-D devices. The current standard of care to achieve optimization is through Echo testing. All patients who consent to participate will receive this aCRT feature installed temporarily on their device at the randomization visit. Following a series of echo recordings, the subject is then randomized to either keep the aCRT feature on their device for the remainder of the study or have it removed. Neither the patient nor doctor will know which group they are assigned to. Approximately 523 subjects will be enrolled in the study at up to 125 centers. Following a 2:1 ratio, approximately 349 subjects will be randomized to the aCRT Treatment arm and approximately 172 subjects will be randomized to the Control Group. These patients will be followed for approximately 12-24 months. Principal Investigator: Simón Milstein, MD

OPTIVOL Care Pathway Study - The purpose of this study is to compare monthly versus quarterly review of Cardiac Compass® Trends with OptiVol for initiation of clinical action. Clinical action may include: medication change, device reprogramming, medication compliance counseling, dietary counseling, clinic visit, ER or urgent care visit, and health care referral. Subjects who enroll will have met all inclusion/exclusion criteria, including having received a Medtronic ICD or CRT-D device, which contains Cardiac Compass Trends and OptiVol Fluid Status Monitoring Features. Currently our “standard of care” is to monitor these patients quarterly, although they may be monitored more frequently if medically necessary. These visits will occur either in office or via CareLink transmission. Subjects will be required to answer questions related to their heart failure following each visit and also be required to complete a Self-Care of Heart Failure Index survey three times during the study. The study is expected to enroll approximately 1,500 patients in the U.S., at up to 200 study centers. Subject participation will last for 12 months following their start date. Principal Investigator: Simón Milstein, MD