Clinical Trials

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60 studies in Division of Cardiovascular Diseases

  1. A Prospective, Randomized, Controlled, Unblinded, Multi-Center Clinical Trial to Evaluate the HeartWare® Ventricular Assist Device System for Destination Therapy of Advanced Heart Failure

    Phoenix/Scottsdale, Ariz., Rochester, Minn. View Summary

    A Prospective, Randomized, Controlled, Unblinded, Multi-Center Clinical Trial to Evaluate the HeartWare® Ventricular Assist Device System for Destination Therapy of Advanced Heart Failure

    Location:

    Phoenix/Scottsdale, Ariz., Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    This is a prospective, randomized, controlled, unblinded, multi-center evaluation of the stroke incidence in patients implanted with a HeartWare® HVAD who receive optimal blood pressure management. The study compares results of stroke incidence in a new cohort of subjects receiving optimal blood pressure management to a reference stroke incidence observed in the original IDE clinical trial (HW004) that did not specify optimal blood pressure management. In addition, a secondary endpoint will evaluate non-inferiority of stroke-free success on the originally implanted device to a control group (i.e. any FDA-approved LVAD for destination therapy).

    NCT ID:

    NCT01966458

    IRB Number:

    13-006972

    Who can I contact for additional information about this study?

    Rochester: Cathy Anderson Severson 507-255-2673
                        
    Scottsdale: Marlene Lind
                        

  2. Application for Self-Monitoring of Cardiovascular Risk

    Rochester, Minn. View Summary

    Application for Self-Monitoring of Cardiovascular Risk

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The study will consist of two phases - an initial feasibility trial (Phase 1), followed by a randomized clinical trial (Phase 2). Once the Phase 1 trial is evaluated, Phase 2 will be implemented. Phase 1 will consist of up to 35 participants to ensure that the software application is user-friendly, properly stores pertinent data, and has no technical glitches. All participants in Phase 1 will have access to the software application and will be asked to complete online questionnaires, at baseline and post cardiac rehab, to assess their quality of life and also their satisfaction with their care and the software application itself. Phase 2 will consist of 65 participants. These participants will be randomized to either 1) CR alone along with answering questionnaires regarding quality of life and satisfaction of care or 2) CR (Cardic Rehab), along with the software application and the quality of life, satisfaction of care and software application questionnaires. All participants (both Phase 1 and Phase 2) enrolled into the study will be status-post percutaneous coronary intervention (PCI). The potential participants will be asked to participate while still in the hospital and will be approached as soon as possible after agreeing to participate in CR,. The participants who enroll in Phase 2 will be randomized prior to discharge from the hospital. All participants in Phase 1 and those in Phase 2 who randomize to the software application will be instructed on the use of either the desktop or smart-phone version of the software application. Baseline information, including participant name, date of birth, email address, and phone number, will be gathered from the participant at that time, and all characteristics will be entered by the participant and study coordinator into their own account in the application. The study will follow all Phase 1 participants and those in Phase 2 who randomize to the software application for three months after hospital dismissal and evaluate the following: - Weight/BMI, blood pressure, and heart rate - Usual lab values already gathered for the participant such as lipids, CBC (Complete Blood Count), and HgbA1C - Quality of life, disposition, and mood - Participant compliance, satisfaction, and adherence to the application - Re-hospitalizations, participants phone calls, and cost of care During the second week of their CR an additional 30-60 minute educational session will be required so that the study coordinator can instruct the participant on the software application and how to use it. We will also ask that participants "log in" to their online account at least 3-4 times weekly for important reminders, care tips, and educational materials. This will last the duration of their cardiac rehabilitation program (approximately 12 weeks). Specific examples of sections within the software application will pertain to medication adherence, diet, exercise, educational materials, and reviews of your medical profile. Finally, we would ask that participants (all of Phase 1 and those who randomize to the software application in Phase 2) to complete online questionnaires, at baseline and post cardiac rehab. that assess their quality of life and also their satisfaction with their care and the software application itself. This will be used for both data purposes as well as in future improvements to the program. These individual surveys will take approximately 5 minutes to complete. Phase 2 study participants who do not randomize to the software application will be sent the quality of life and satisfaction of care questionnaires.

    NCT ID:

    NCT01883050

    IRB Number:

    11-004546

    Who can I contact for additional information about this study?

    Rochester: Pamela R Vega, B.S. 507-255-6884
                        


  3. An Evaluation of Rigid Sternal Fixation in Supporting Bone Healing and Improving Postoperative Recovery: A Prospective, Randomized Trial

    Jacksonville, Fla. View Summary

    An Evaluation of Rigid Sternal Fixation in Supporting Bone Healing and Improving Postoperative Recovery: A Prospective, Randomized Trial

    Location:

    Jacksonville, Fla.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Rigid sternal fixation with the BIOMET SternaLock Blu Sternal Closure System may result in greater sternal stability that leads to superior sternal bone healing, less postoperative pain and narcotic usage, and improved functional outcomes compared to wire cerclage. The health economics analysis is an interesting component of this study, in which cost and billing data will be collected from participating sites and analyzed in terms of cost/effectiveness for patients and healthcare system.

    NCT ID:

    NCT01783483

    IRB Number:

    13-003077

    Who can I contact for additional information about this study?



    Jacksonville: Mauricia Buchannan, RN 904-953-9455
                        
  4. The Assessment of Novel Functional Risk Factors for the Prediction of Cardiovascular Events in Vulnerable Patients Following Acute Coronary Syndrome

    Rochester, Minn. View Summary

    The Assessment of Novel Functional Risk Factors for the Prediction of Cardiovascular Events in Vulnerable Patients Following Acute Coronary Syndrome

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The purpose of this study is to determine if testing patients for endothelial dysfunction will help identify which patients are more likely at risk to have another heart attack in the future. Study participants will undergo mental stress testing while at the same time being connected to a device that measures endothelial function via the Endopat device. These same participants will also undergo a sleep study via the Watchpat device.

    NCT ID:

    NCT01500902

    IRB Number:

    09-000047

    Who can I contact for additional information about this study?

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


  5. Phase I Safety Study of Autologous Umbilical Cord Blood Derived Mononuclear Cells During Surgical Stage II Palliation of Hypoplastic Left Heart Syndrome

    Rochester, Minn. View Summary

    Phase I Safety Study of Autologous Umbilical Cord Blood Derived Mononuclear Cells During Surgical Stage II Palliation of Hypoplastic Left Heart Syndrome

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    This study is a Phase I trial to determine the safety of autologous mononuclear cells (MNC) derived from umbilical cord blood for intramyocardial delivery into the right ventricle during a planned and non-emergent Stage II surgical palliation in subjects with HLHS. This is the first critical step towards applying autologous MNC therapy as an add-on regenerative intervention for congenital heart disease management. The choice of HLHS as the target disease for regenerative therapies in congenital heart disease management is multi-factorial and includes the following considerations: 1) Severity of of this incurable disease, 2) palliative nature and burden of long-term outcomes with a single right ventricular system, 3) three stages of planned surgical procedures that provide time points to adjunctively intervene, and 4) prenatal diagnosis enabling planned collection of UCB. An emerging goal for cardiac regeneration includes the application of cell-based technology to congenital heart disease, which is a favorable substrate due to the lack of fibrotic scaring, and the presence of a microenvironment that is expected to support ongoing cardiac proliferation and growth for functional remuscularization. This Phase I safety study will determine the feasibility of collection, processing, and delivery of autologous cells as used in adult cardiac regenerative protocols in the setting of HLHS surgical management.

    NCT ID:

    NCT01883076

    IRB Number:

    12-008521

    Who can I contact for additional information about this study?

    Rochester: Julia Thebiay 507-538-8425
                        


  6. Define in Humans With Compensated CHF and Renal Dysfunction, the Modulating Action of Chronic AT1 Receptor Blockade in Addition to ACE Inhibition on Cardiorenal and Humoral Function

    Rochester, Minn. View Summary

    Define in Humans With Compensated CHF and Renal Dysfunction, the Modulating Action of Chronic AT1 Receptor Blockade in Addition to ACE Inhibition on Cardiorenal and Humoral Function

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    To advance our understanding of the mechanisms of human cardiorenal syndrome with emphasis upon the interaction of diuretic therapy and the renal-angiotensin-aldosterone -system and cGMP pathway. The belief is that the chronic AT1 receptor blockade in subjects with compensated CHF and renal dysfunction will improve renal function with increased sodium excretion, glomerular filtration rate and effective renal plasma flow and renal function reserve as compared to the response of placebo-treated subjects.

    NCT ID:

    NCT01678794

    IRB Number:

    09-003284

    Who can I contact for additional information about this study?

    Rochester: Lynn Harstad 507-284-4838
                        


  7. Clinical Trials - Mayo Clinic Research

    Rochester, Minn. View Summary

    Clinical Trials - Mayo Clinic Research

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    This study is being done to better understand how genetic information might improve assessment of heart attack risk.


    NCT ID:

    NCT01936675

    IRB Number:

    12-001727

    Who can I contact for additional information about this study?

  8. A Prospective Study to Determine the Association of Quantitated Blood and Plasma (Intravascular) Volume to Right Heart Hemodynamics, Venous Capacitance, and Regulatory Neurohormones in Patients With Chronic Heart Failure of Reduced and Preserved Ejection Fraction

    Rochester, Minn. View Summary

    A Prospective Study to Determine the Association of Quantitated Blood and Plasma (Intravascular) Volume to Right Heart Hemodynamics, Venous Capacitance, and Regulatory Neurohormones in Patients With Chronic Heart Failure of Reduced and Preserved Ejection Fraction

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The purpose of this study is to learn more about how the heart, blood vessels and blood volume interact in patients with heart failure and how measuring blood volume and vein capacity may help us develop better ways of treating and managing heart failure patients. This study will use two tests to measure blood volume and test the capacity of your veins and arteries in your limbs. The blood volume test (also called a plasma volume test or a red cell mass test) is a standard clinical nuclear lab procedure used to measure the volume (amount) of blood in the body. The test also measures the volume of plasma and of red cells in the blood. The other test is called a venous plethysmography, which is a non-invasive test to measure how well your veins and arteries in your forearm and calf work. Venous plethysmography measures the changes in the dimensions of your limbs by the use of strain gauges placed on the skin.

    NCT ID:

    NCT02120014

    IRB Number:

    13-003912

    Who can I contact for additional information about this study?

  9. 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
  10. Rate-Adaptive Atrial Pacing In Diastolic Heart Failure (RAPID-HF)

    Rochester, Minn. View Summary

    Rate-Adaptive Atrial Pacing In Diastolic Heart Failure (RAPID-HF)

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Determine the impact of restoring normal heart rate response during exercise and daily activity in patients with heart failure and a preserved ejection fraction (HFpEF) and chronotropic incompetence (CI).

    NCT ID:

    NCT02145351

    IRB Number:

    13-008306

    Who can I contact for additional information about this study?

    Rochester: Peggy Weivoda 507-255-8923
                        


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