Clinical Trials

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19 studies in Division of Cardiovascular Diseases

  1. Drug Therapy for the Treatment of Anemic Patients with Congestive Heart Failure
    Rochester, Minn. View Summary

    Drug Therapy for the Treatment of Anemic Patients with Congestive Heart Failure

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    This research study is being done to see if the investigational use of the drug darbepoetin alfa, which is given to treat anemia (low number of red blood cells), will have an effect on your ability to exercise on a treadmill and on your clinical symptoms.  Previous observations in a small number of patients suggests that improved blood counts may improve these symptoms.

    IRB Number:

    1049-02

    Who can I contact for additional information about this study?

      Dr. Barry L. Karon
      Study Coordinator: Annette McNallan, RN (507) 266-3639 or pager 127-07890
  2. Assessment of Right Ventricular Volume Using the Ventripoint Medical System in Patients With Tetralogy of Fallott Following Repair; A Comparison Study to cMRI
    Rochester, Minn. View Summary

    Assessment of Right Ventricular Volume Using the Ventripoint Medical System in Patients With Tetralogy of Fallott Following Repair; A Comparison Study to cMRI

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Assessment of Right Ventricular Volume using the VentriPoint Medical system in patients with Tetralogy of Fallot following repair; a comparison study to cMRI. The objective of this study is: To evaluate the accuracy of the VentriPoint Medical System to calculate right ventricular volumes in patients with Tetralogy of Fallot following surgical repair. Secondary objectives are: To validate Inter and Intra observer variability at 3 clinical sites. The analyses will be the same for EDV and ESV. For either right ventricular volume, the primary effectiveness measure is the % difference between VMS and cMRI results, i.e. (VMS-cMRI)*100%/average of VMS and cMRI results. There will be two null hypotheses for the primary analysis: H0+: true mean % difference > 10% and H0-: true mean % difference < -10% The observed mean % difference will be presented with 95% confidence intervals. The VMS right ventricular volume estimates will be regarded as equivalent to cMRI estimates if both H0+ and H0- are rejected at a 1-sided 0.025 level by a paired t test for both EDV and ESV. Since H0+ and H0- cannot both be true, the total type I error rate for each measure is 0.025 and the overall type I error rate for both EDV and ESV is 0.05.

    NCT ID:

    NCT01419756

    IRB Number:

    12-003920

    Who can I contact for additional information about this study?

    Rochester: Benjamin Eidem, MD
                        


  3. Is Our Microbiome a Predictor of Cardiac Risk?
    Rochester, Minn. View Summary

    Is Our Microbiome a Predictor of Cardiac Risk?

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The purpose of this study is to determine a relationship between a person's flora/bacteria in their gut (the intestinal microbiome) and their risk of cardiovascular disease. Investigators will look at inflammatory markers in the blood and also look at the genome of the bacteria in the gut. This research is being done because Investigators believe that there is a connection between the way food is digested by a person's gut bacteria and the development of atherosclerosis (hardening of the arteries) and cardiovascular disease. The ultimate goal of this research is to eventually determine if changes to the gut bacteria can prevent cardiovascular disease or disease progression.

    NCT ID:

    NCT02013284

    IRB Number:

    13-007084

    Who can I contact for additional information about this study?

    Rochester: Rebecca E. Nelson, CCRC 507-255-8388
                        


  4. Xanthine Oxidase Inhibition for Hyperuricemic Heart Failure Patients
    Rochester, Minn. View Summary

    Xanthine Oxidase Inhibition for Hyperuricemic Heart Failure Patients

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The purpose of this study is to determine whether allopurinol is effective in relieving symptoms of patients with heart failure and high blood uric acid levels.

    NCT ID:

    NCT00987415

    Who can I contact for additional information about this study?

    Rochester: Margaret Redfield, MD
                        


  5. Cardiac Vascular Reconstruction (CAVAREC) DynaCT for 3D Assessment of Aortic Valve During TAVI Procedures
    Rochester, Minn. View Summary

    Cardiac Vascular Reconstruction (CAVAREC) DynaCT for 3D Assessment of Aortic Valve During TAVI Procedures

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The purpose of this work is to evaluate the feasibility of a new Cardiac Vascular Reconstruction (CAVAREC, Siemens Medical Systems, Germany) image reconstruction algorithm for use during transcatheter aortic valve implant (TAVI) procedures. CAVAREC utilizes the same x-ray projection images as currently acquired for clinical DynaCT. X-ray image acquisition to allow CAVAREC will occur during the TAVI procedure both before and after the TAVI device is implanted. The CAVAREC image processing algorithm will be implemented on an off-line workstation after the TAVI procedure is complete. After the TAVI procedure, CAVAREC images will be quantitatively and qualitatively compared to Siemens DynaCT and cardiac CT images from Radiology. The results of this study will be used to direct further development of CAVAREC toward the end goal of providing improved imaging capabilities to guide TAVI procedures.

    NCT ID:

    NCT02031796

    IRB Number:

    13-004257

    Who can I contact for additional information about this study?

    Rochester: Verghese Mathew, M.D. 507-538-1469
                        Pamela R. Vega, B.S. 507-255-6884


  6. Effects of Chardonnay Seed Flour on Vascular Health
    Rochester, Minn. View Summary

    Effects of Chardonnay Seed Flour on Vascular Health

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    This is a randomized, double-blinded trial (Chardonnay seed flour vs. placebo - in pill form) with the purpose to test the impact of a four-month supplementation with Chardonnay Seed Flour (CSF) on endothelial function. Chardonnay flour is made from wine grape skins and seeds. We will examine the effect of CSF on parameters such as endothelial function (via EndoPAT testing), plasma lipid levels, glucose tolerance, insulin resistance, inflammatory markers, oxidative stress surrogates, endothelial progenitor cells (EPCs) as well as the makeup of and impact on the gut microbiome (via stool samples).

    NCT ID:

    NCT02093455

    IRB Number:

    13-007023

    Who can I contact for additional information about this study?

  7. Umbilical Cord Blood Collection and Processing for Cardiac Regeneration in Hypoplastic Left Heart Syndrome Patients
    Rochester, Minn. View Summary

    Umbilical Cord Blood Collection and Processing for Cardiac Regeneration in Hypoplastic Left Heart Syndrome Patients

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Cell-based cardiac regeneration has been the focus of acquired, adult heart disease for many years. However, congenital heart disease with severe structural abnormalities may also be reasonable targets for cell-based therapies. Interestingly, the pediatric heart is naturally growing and may be the most amendable to regenerative strategies. Therefore, identifying autologous cells (cells from the patient's own body) would be important to initiate these studies. This study aims to validate the use of umbilical cord blood as a source of autologous cells for the purpose of cardiac repair of congenital heart disease. Cells will be isolated from the cord blood to help us determine the feasibility of collection, processing, and storage of these samples at the time of birth of infants with prenatal diagnosis of hypoplastic left heart syndrome. This study may be useful for the development of pre-clinical and clinical studies aimed at the long-term goal of repairing damaged heart muscle.

    NCT ID:

    NCT01856049

    IRB Number:

    11-007176

    Who can I contact for additional information about this study?

  8. Promotion of Renal Sodium Excretion by Renal Sympathetic Denervation in Congestive Heart Failure
    Rochester, Minn. View Summary

    Promotion of Renal Sodium Excretion by Renal Sympathetic Denervation in Congestive Heart Failure

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Congestive heart failure is a common disorder in which the heart cannot pump enough blood to meet the needs of the rest of the body. Poor sodium handling by the kidneys is a damaging effect of heart failure, and it leads to symptoms of congestion such as shortness of breath or ankle swelling. Recent studies suggest that reducing the nerve activity to a kidney could reduce sodium retention and blood pressure. An improvement in the way the kidneys handle sodium may reduce disease progression and decrease symptoms for heart failure patients.

    NCT ID:

    NCT01954160

    IRB Number:

    13-006777

    Who can I contact for additional information about this study?

    Rochester: Janet Gatzke
                        


  9. Chemometric Observation of Lipid Core Plaques of Interest in Native Coronary Arteries Registry
    Rochester, Minn. View Summary

    Chemometric Observation of Lipid Core Plaques of Interest in Native Coronary Arteries Registry

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    In April 2008, a coronary catheter based imaging system, LipiScan, was cleared by the FDA for use in detecting lipid core containing containing plaques of interest (LCP). These plaques are rich in cholesterol. The way that cholesterol and other lipids deposit with the coronary artery is unique to each patient. This study is an organized attempt to observe the LCP and the variety of ways that it presents in patients as detected by this recently approved device. This information will be used for physician training and to observe the behavior of the LCP in response to no therapy and currently approved therapies. The purpose of this project is further medical knowledge of the LCP and its treatment.

    NCT ID:

    NCT00831116

    Who can I contact for additional information about this study?

    Rochester: Cindy M Woltman, RN 507-266-4095
                        


  10. Establishment of Normal Ranges for Newly Developed Cardiovascular Assays
    Rochester, Minn. View Summary

    Establishment of Normal Ranges for Newly Developed Cardiovascular Assays

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    This research study is being done to determine levels of proteins that are normally present in the blood and urine of healthy individuals so as to compare to those levels in patients with heart disease.

    Normal blood and urine will be analyzed for levels of proteins and cardiac peptides which are affected by heart disease in the elderly. We are trying to determine if there are normal age-related changes when heart disease is not involved.

    IRB Number:

    718-05

    Who can I contact for additional information about this study?

    If you are interested in participating in this study or would like additional information, please contact Sharon Sandberg or Dr. Fernando Martin at (507) 284-4838.
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