Clinical Trials

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59 studies in Division of Cardiovascular Diseases

  1. Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure.

    Rochester, Minn. View Summary

    Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure.

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Heart failure is a common disorder in which the heart cannot pump enough blood to meet the needs of the rest of the body. Common symptoms of heart failure include shortness of breath, swelling, and fatigue. Standard treatment for heart failure include diuretics to control fluid, as well as drugs called "neurohormonal antagonists" (such as beta-blockers and ACE-inhibitors) that help the heart work more efficiently and prevent worsening of heart function. Typically, doctors adjust these medicines based on their clinical judgment about what doses and combination will work best for you. We are testing whether the use of a blood test called NT-proBNP (which measures a hormone released by the heart) can help doctors do a better job of adjusting these heart failure medicines over time than clinical judgment alone.

    NCT ID:

    NCT01685840

    IRB Number:

    13-002314

    Who can I contact for additional information about this study?

    Rochester: Wayner Miller, MD 507-284-3685
                        


  2. Micra Transcatheter Pacing Study

    Rochester, Minn. View Summary

    Micra Transcatheter Pacing Study

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The study is expected to be conducted in up to 70 sites located around the world, including up to 35 sites in the United States (U.S.).Participating geographies may include countries such as the U.S, Europe, China, India, Malaysia, and Japan. Up to 780 subjects will be enrolled (i.e. consented) to allow up to 720 subjects to be implanted enabling at least 600 subjects to be followed for at least 12-months post-implant. There are two primary objectives in this study (one safety and one efficacy). The primary safety objective of the study is to evaluate major complications related to the Micra system or procedure. The primary safety endpoint will be evaluated at 6-months (183 days) post-implant. The primary efficacy objective, Micra pacing capture thresholds, will also be evaluated six months post-implant. This study also has a separate long term safety objective that will provide additional long-term safety data following potential regulatory submissions. All subjects will be followed until official study closure (official study closure is defined as when Medtronic and/or FDA requirements have been satisfied per the Clinical Investigational Plan and/or by a decision by Medtronic or regulatory authority).

    NCT ID:

    NCT02004873

    IRB Number:

    14-003022

    Who can I contact for additional information about this study?

  3. Early Treatment Versus Delayed Conservative Treatment of the Patent Ductus Arteriosus in Preterm infants-a Multicenter Trial

    Rochester, Minn. View Summary

    Early Treatment Versus Delayed Conservative Treatment of the Patent Ductus Arteriosus in Preterm infants-a Multicenter Trial

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Prior studies showed that, if a moderate/large Patent Ductus Arteriosus (PDA) is still present at 5 days after birth (among infants delivered at 23 and 0/7 to 25 and 6/7 weeks gestation) or at 7 days after birth (among infants delivered at 26 and 0/7 to 27 and 6/7 weeks gestation), it will persist for at least another 4-12 weeks if it is left untreated.

    NCT ID:

    NCT01958320

    IRB Number:

    13-001922

    Who can I contact for additional information about this study?

  4. Systolic Pressure Intervention Trial (SPRINT)-Factors Affecting Factors Affecting Atherosclerosis Study (FAST)

    Jacksonville, Fla. View Summary

    Systolic Pressure Intervention Trial (SPRINT)-Factors Affecting Factors Affecting Atherosclerosis Study (FAST)

    Location:

    Jacksonville, Fla.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Systolic Pressure Intervention Trial (SPRINT) is a large scale randomized trial of ~ 9250 adults aged 50 years or older with high cardiovascular risk sponsored by NIH. The study is designed to recruit 45% of the study population with Chronic Kidney Disease (CKD). The trial will test the effects of low systolic blood pressure (SBP) goal of < 120 mm Hg versus the standard goal of < 140 mm Hg on the primary composite of cardiovascular events and death. One of the pre-specified secondary outcome is the progression of kidney disease. In this ancillary named SPRINT - Factors affecting Atherosclerosis STudy (FAST), the investigators plan to take advantage of the unique opportunities afforded by the parent study to examine issues that are of significant public health importance. This is an observational study in SPRINT participants. This study will examine mechanistically, the factors affecting the progression of atherosclerosis in CKD.

    NCT ID:

    NCT01475747

    IRB Number:

    12-006936

    Who can I contact for additional information about this study?



    Jacksonville: Anna Harrell
    904-953-2255

                        
  5. A Double-blind, Randomized, Sham-procedure-controlled, Parallel-group Efficacy and Safety Study of Allogeneic Mesenchymal Precursor Cells (CEP-41750) in Patients With Chronic Heart Failure Due to Left Ventricular Systolic Dysfunction of Either Ischemic or Nonischemic Etiology

    Rochester, Minn. View Summary

    A Double-blind, Randomized, Sham-procedure-controlled, Parallel-group Efficacy and Safety Study of Allogeneic Mesenchymal Precursor Cells (CEP-41750) in Patients With Chronic Heart Failure Due to Left Ventricular Systolic Dysfunction of Either Ischemic or Nonischemic Etiology

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The primary objective of this study is to determine whether transendocardial delivery of allogeneic human bone marrow-derived MPCs (CEP-41750) is effective in the treatment of chronic heart failure due to LV systolic dysfunction.

    NCT ID:

    NCT02032004

    IRB Number:

    14-000313

    Who can I contact for additional information about this study?

  6. Cardiovascular Effects of Energy Drinks in Healthy Adults

    Rochester, Minn. View Summary

    Cardiovascular Effects of Energy Drinks in Healthy Adults

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    This study is being done to look at the cardiovascular response, if any, to intake of commercially available energy drink. We hypothesize that energy drink consumption compared to a control drink in healthy adults alters the cardiovascular hemodynamic system.

    NCT ID:

    NCT01940822

    IRB Number:

    13-001918

    Who can I contact for additional information about this study?

    Rochester: Anna Svatikova, MD, PhD
                        


  7. Phosphodiesterase Type 5 Inhibition With Tadalafil Changes Outcomes in Heart Failure

    Rochester, Minn. View Summary

    Phosphodiesterase Type 5 Inhibition With Tadalafil Changes Outcomes in Heart Failure

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    This study is a multi-center, prospective, randomized, double blind, placebo-controlled clinical trial. Subjects in the study will be adults with New York Heart Association (NYHA) Class II-IV heart failure (HF) due to left ventricular systolic dysfunction (LVSD), left ventricular ejection fraction (LVEF) <0.40, and secondary pulmonary hypertension (PH). The purpose of the study is to evaluate the safety, effectiveness, and effects of tadalafil compared to placebo on the subjects' functional capacity / quality of life.

    NCT ID:

    NCT01910389

    IRB Number:

    13-005779

    Who can I contact for additional information about this study?

  8. Pressure-Volume Analysis of Constrictive Pericarditis

    Rochester, Minn. View Summary

    Pressure-Volume Analysis of Constrictive Pericarditis

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Until now, diagnosis of constriction was based on pressure changes of ventricle by conventional pressure-wide hemodynamic evaluation but not on ventricular volume change. This study will provide answers to persisting questions about volume changes during respiration in patients with constrictive pericarditis by directly measuring both right and left ventricular volume.

    NCT ID:

    NCT02027350

    IRB Number:

    13-008074

    Who can I contact for additional information about this study?

  9. Nitrate s Effect on Activity Tolerance in Heart Failure With Preserved Ejection Fraction

    Rochester, Minn. View Summary

    Nitrate s Effect on Activity Tolerance in Heart Failure With Preserved Ejection Fraction

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    To evaluate whether isosorbide mononitrate increases daily activity as assessed by 14-day averaged arbitrary accelerometry units in comparison to placebo.

    NCT ID:

    NCT02053493

    IRB Number:

    13-007507

    Who can I contact for additional information about this study?

    Rochester: Janet Gatzke 507-538-7177
                        


  10. Sleep Apnea and Vascular Function

    Rochester, Minn. View Summary

    Sleep Apnea and Vascular Function

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Obstructive sleep apnea (OSA) is associated with endothelial dysfunction and the development of cardiovascular disease. It is unclear how OSA results in endothelial dysfunction, but given the association between OSA and obesity, adipose-derived hormones (adipokines) are likely to be involved. Leptin, an adipokine upregulated in patients with OSA, has been shown to be associated with deleterious effects on vascular function resulting in impaired endothelial function. This proposal is directed at investigating the molecular mechanisms of endothelial dysfunction in OSA patients. We hypothesize that endothelial dysfunction associated with OSA is a result of molecular alterations within endothelial cells. As a part of these studies we will look at NO signaling pathways in adipose tissue and microvessels from normal and OSA subjects.

    NCT ID:

    NCT01717339

    IRB Number:

    12-006285

    Who can I contact for additional information about this study?

    Rochester: Diane E Davison, RN, MA
                        


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