Clinical Trials

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67 studies in Division of Cardiovascular Diseases

  1. Define in Preclinical Systolic Dysfunction (PSD) With Renal Dysfunction, the Cardiorenal and Humoral Actions of Chronic Type V Phosphodiesterase (PDEV) Inhibition

    Rochester, Minn. View Summary

    Define in Preclinical Systolic Dysfunction (PSD) With Renal Dysfunction, the Cardiorenal and Humoral Actions of Chronic Type V Phosphodiesterase (PDEV) Inhibition

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    At the consent visit a blood draw will be done also a the 6 minute walk will be done to determine eligibility and a physical exam along with vital signs, height and weight will be done. Twenty-four hour urine collection will be obtained one day prior to the active study day. Prior to initiation of the study, subjects will be stabilized for at least one week on a no added salt diet (120 milliequivalents of sodium/salt per day (mEq Na/day) which will be maintained throughout the study period. Subjects will be admitted to the Clinical Research Unit (CRU)on the evening before the active study day. They will be able to order a no-added salt meal and will not have anything to eat after midnight until the last renal clearance blood draw the next day. Bladder scan will be carried out to assess for urine retention. On the active study day, subjects take their medications upon awakening, however, diabetics will hold their diabetic medications until after the last renal clearance test then they will be able to order a regular diet meal and take their diabetic medications. Subjects will be asked to drink 5ml/Kg (milliliters per kilogram of body weight) of water to insure sufficient urinary flow. A priming dose (calculated according to body size) of Iothalamate, to measure glomerular filtration rate (GFR) and para-amino-hippurate (PAH) to measure effective renal plasma flow (ERPF) is infused, followed by a constant rate IV sustaining dose (calculated according to estimated kidney function) of Iothalamate or PAH. The subjects will be asked to empty their bladder spontaneously every thirty minutes. Throughout the study, at the end of each 30-minute clearance period, subjects will be asked to drink an amount of water equivalent to the sum of the blood losses and the urinary flow. After an equilibration period of 45 minutes, a 30-minute baseline renal clearance will be carried out. Blood pressure will be measured at 20-minute intervals by using automatic blood pressure cuff, and heart rate will be continuously monitored by electrocardiography. Echocardiography will be performed during these baseline clearances to determine left atrial (LA) and Left Ventricular (LV)volumes and systolic and diastolic function. After the baseline clearance the acute saline load will be administered (normal saline 0.9% 0.25 ml/kg/min for 1 hour). During the 1 hour saline load, one 30-minute clearance (as outlined above) will be repeated with the subjects in supine position after which a second 30-minute clearance will be repeated with the subject sitting or the head of the bed up. As above, blood samples are collected midway during each clearance and urine samples are obtained every 30 minutes. Echocardiography will be repeated immediately after the end of the saline infusion. At the completion of the baseline renal clearance periods and response to acute sodium load, subjects will be randomized to Tadalafil or placebo. Subjects will be randomized in a 2:1 fashion. All subjects will take oral Tadalafil (5 mg) or placebo once a day. The blood pressure will be checked prior to administering the drug.Thereafter, both blood pressure and heart rate will continue to be monitored for the next 4 hours. If after the first dose of study drug if patient's systolic blood pressure is < 85 mmHg systolic and has symptoms of hypotension e.g. lightheadedness, dizziness, feeling faint, blurred vision, the study drug will be stopped however the subject will continue in the study. After 2 hours if blood pressure is >95 systolic then give 1 more (5 mg) of Tadalafil or placebo and monitor blood pressure for 2 hours. If blood pressure is >95 then dismiss subject on 2 (5 mg) tabs of tadalafil or placebo. If blood pressure is between 90 - 95 mmHg systolic, then dismiss on 1 (5 mg) tab of Tadalafil or placebo. Patients will then be dismissed. Subjects will also have access to a 24-hour phone number should they have any questions or develop any side effects. Subjects will return after one week (+ or - 4 days) for electrolyte check. They will also receive a weekly phone call to review status. At 2 weeks (± 5 days) from dismissal if blood pressure is> 100 than add 1 (5 mg) tab of Tadalafil or placebo to make a total of 3 (5mg) tabs of Tadalafil or placebo. At 4 weeks(± 5 days) if blood pressure is > 100 add 1 (5 mg) tab to make a total of 4 (5 mg) Tadalafil or placebo. After six weeks( + or - 5 days) , subjects will repeat blood draw for safety labs (total blood count and electrolytes). For patients who do not live more than 25 miles away we will try to arrange this visit with the patient's local physician. At the end of the twelve-week study period (+ or - 8 days), subjects will be admitted to the Clinical Research Unit the afternoon prior to the renal clearance study. Echocardiography, renal clearance, humoral determination and acute saline load will be performed in the same manner as the baseline study. Subjects will also perform a 24-hour urine collection the day prior to their return visit for determination of sodium excretion and creatinine clearance. Subjects will be dismissed after the renal clearance study.

    NCT ID:

    NCT01970176

    IRB Number:

    11-004644

    Who can I contact for additional information about this study?

    Rochester: Sherry L Benike, RN 507-266-3629
                        


  2. Assessment of Myocardial Tissue Damage in Aortic Stenosis for Risk Stratification

    Phoenix/Scottsdale, Ariz. View Summary

    Assessment of Myocardial Tissue Damage in Aortic Stenosis for Risk Stratification

    Location:

    Phoenix/Scottsdale, Ariz.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Aortic stenosis (AS) is the most common valve disease in the United States and most common indication for valve replacement surgery. Anatomical and hemodynamic severity of AS is insufficient for elucidating patients' prognosis. Therefore, the decision about the optimal timing of surgical intervention remains critical. However, the changes in structure and electrical activity of the cardiac muscle can be assessed by noninvasive imaging and electrocardiography (ECG). Degenerative myocardial changes characterized by fibrosis or collagen deposits are frequently observed in AS patients and have a negative impact on patient outcomes. In this project, our objective is to determine whether echocardiographic image analysis of integrated backscatter (IB), which can express changes in myocardial tissue composition (amount of fibrosis) based on its ultrasound reflectivity, global left ventricular (LV) load as measured by Zva, and ECG analysis of the duration of the QRS interval have a role in risk stratification for AS patients and to apply those methods to identify which patients would benefit from surgical intervention. The investigators hypothesize that 1) the severity of myocardial damage can discriminate the prognosis in patients with AS, and 2) IB, Zva, and QRS interval can be diagnostic measures of the severity of myocardial damage. The investigators will measure the severity of myocardial fibrosis using MRI (reference) in 50 patients and will test the diagnostic significance of IB (testing method). Zva, QRS duration, and conventional echocardiographic measures will also be tested for diagnosing severity of myocardial fibrosis.

    NCT ID:

    NCT02101619

    IRB Number:

    13-004385

    Who can I contact for additional information about this study?


    Scottsdale: Minako Katayama, MD 480-301-9063
                        

  3. 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?

  4. The Assessment of Prednisone In Remission Trial (TAPIR) - Centers of Excellence Approach

    Rochester, Minn. View Summary

    The Assessment of Prednisone In Remission Trial (TAPIR) - Centers of Excellence Approach

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Patients with granulomatosis with polyangiitis (GPA, Wegener's) will be recruited at one of the Vasculitis Centers of Excellence. Participants will be randomized 1:1 either to taper their prednisone dose down to 5 mg/day according to a standardized schedule and stay at 5 mg/day of prednisone for the duration of the study or until a study endpoint, or taper their prednisone dose down to 0 mg/day using a standard schedule and stay at 0 mg/day for the duration of the study or until a study endpoint. All study participants will be followed for 6 months (from reaching a prednisone dose of 5 mg/day) or until an increase of prednisone dose (after randomization) occurs, whichever comes first. Participants will have up to four study visits, a screening visit (visit 1), a baseline (visit 2), a month 3 visit (visit 3) and a month 6 or flare visit (visit 3) and up to two follow-up phone calls from the study coordinator at randomization and at month 1 (randomization and 1 month phone call may be combined if randomization occurs at month 1). This study is a project of the Vasculitis Clinical Research Consortium (VCRC) funded through the National Institutes of Health Rare Diseases Clinical Research Network (RDCRN) with the purpose of promoting vasculitis research. The VCRC is the major clinical research infrastructure in North America for the study of vasculitis, and eight VCRC Centers of Excellence will be recruiting for this study.

    NCT ID:

    NCT01940094

    IRB Number:

    14-000573

    Who can I contact for additional information about this study?

    Rochester: Cindy Beinhorn
                        


  5. Acute Effects of Inhaled Sodium Nitrite on Cardiovascular Hemodynamics in Heart Failure With Preserved Ejection Fraction

    Rochester, Minn. View Summary

    Acute Effects of Inhaled Sodium Nitrite on Cardiovascular Hemodynamics in Heart Failure With Preserved Ejection Fraction

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Patients referred to the cardiac catheterization laboratory for invasive exercise stress testing will be prospectively recruited. Standard right heart catheterization using high fidelity micromanometers (Millar Instruments) will be performed at rest and during supine exercise with simultaneous expired gas analysis (Medgraphics) as is the investigator's current practice. The protocol is rest—passive leg elevation--20 Watts exercise x 5 minutes, and then graded workload increases in 10Watt increments (3 minute stages) to exhaustion. Hemodynamic, arterial and mixed venous blood gas and expired gas data are acquired at rest, during each exercise stage and at peak exercise. Venous blood samples will be obtained at rest and at peak exercise. Perceived symptoms of dyspnea and fatigue will be quantified using the Borg dyspnea and effort scores at each stage of exercise. After the initial exercise study and hemodynamics have returned to baseline, previously prepared study drug (normal saline placebo or Sodium Nitrite Inhalation Solution (AIR001) 90mg placed into the medication chamber) will be nebulized utilizing the Aerogen Solo-Idehaler over 10-15 minutes. After a 15 minute observation period post completion of nebulization, resting hemodynamic and expired gas data will be acquired exactly as in the initial run. Subjects will then repeat the leg elevation-20 Watt x 5 minutes exercise phase. Blood samples will be again obtained at rest and with exercise. Subjects will repeat exercise only at the 20 Watt stage, rather repeating the entire study. This is done to increase the feasibility and shorten the time of the case. The investigators have previously observed that the vast majority (>85%) of the elevation in cardiac filling pressures and reduction in venous oxygen content in people with HFpEF occurs at the low 20 Watt workload, so repeating exercise hemodynamic assessment at this load should be sufficient to detect any clinically meaningful treatment effect.

    NCT ID:

    NCT02262078

    IRB Number:

    14-005091

    Who can I contact for additional information about this study?

  6. MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF TRANSENDOCARDIAL INJECTION OF IXMYELOCEL-T IN SUBJECTS WITH HEART FAILURE DUE TO ISCHEMIC DILATED CARDIOMYOPATHY (IDCM).

    Phoenix/Scottsdale, Ariz. View Summary

    MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF TRANSENDOCARDIAL INJECTION OF IXMYELOCEL-T IN SUBJECTS WITH HEART FAILURE DUE TO ISCHEMIC DILATED CARDIOMYOPATHY (IDCM).

    Location:

    Phoenix/Scottsdale, Ariz.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The primary objective of this study is to evaluate the efficacy of ixmyelocel-T compared to placebo (vehicle control) on the average per patient number of all-cause deaths, cardiovascular hospital admissions, and unplanned outpatient or emergency department visits to treat acute decompensated heart failure, over the 12 months following administration of investigational product (IP).

    NCT ID:

    NCT01670981

    IRB Number:

    13-001455

    Who can I contact for additional information about this study?

    Rochester: Bola Aduloju, RN 507-255-2831
                        Cindy M. Woltman, RN 507-266-4095
    Scottsdale: Barbara Knight 480-342-2545
                        
    Jacksonville: Estela Staggs 904-953-8509
                        
  7. A Phase II Clinical Study of the Safety and Performance of the Treovance Stent-Graft With Navitel Delivery System for Patients With Infrarenal Abdominal Aortic Aneurysms

    Rochester, Minn. View Summary

    A Phase II Clinical Study of the Safety and Performance of the Treovance Stent-Graft With Navitel Delivery System for Patients With Infrarenal Abdominal Aortic Aneurysms

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    This is a phase II, multi-center, non-blinded, non-randomized study of treatment with the Treovance Stent-Graft in subjects with abdominal aortic aneurysms. The study will include 150 subjects treated with the Treovance Stent-Graft at a maximum of 30 investigational sites. There will be no prospective control group. Subjects diagnosed with infrarenal abdominal aortic aneurysms enrolled in the trial will be treated with the Treovance Stent-Graft with Navitel Delivery System. Pre-procedure baseline data will be gathered, as well as post-procedure assessments prior to hospital discharge and 30 days, 6 months, and 12 months post-implantation. In addition, annual follow-up visits out to 5 years will be conducted. The primary goal of this study is to gather safety and effectiveness data on the Treovance device. A maximum of 150 endovascular subjects will be required to fulfill the U.S. Phase II requirements. The data from this study will be submitted to the FDA and used to support approval in the U.S. There are two primary objectives, efficacy and safety of the Treovance Stent-Graft in subjects with infrarenal aortic aneurysms: - Primary Efficacy will be evaluated by successful aneurysm treatment 12 months post-implant - Primary Safety will be assessed by composite major adverse event (MAE) rate at 30-days Secondary objectives involve assessment of major device-related events and major morbidity.

    NCT ID:

    NCT02009644

    IRB Number:

    13-007737

    Who can I contact for additional information about this study?

  8. A Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the PAH-SYMPACT Instrument

    Rochester, Minn. View Summary

    A Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the PAH-SYMPACT Instrument

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    SYMPHONY is prospective, multi-center, open-label, single-arm, Phase 3b psychometric validation study of the PAH-SYMPACT, a new quality of life questionnaire for patients with pulmonary arterial hypertension. Patients will be in the study for 5 1/2 months, 4 months of which they will receive macitentan, 10 mg, once daily. The primary objectives are to demonstrate the final content validity of the PAH SYMPACT instrument, to demonstrate the psychometric characteristics of reliability and construct validity of the PAH-SYMPACT instrument, and to demonstrate the ability of the PAH SYMPACT instrument to detect change. The secondary objective is to assess the safety of macitentan in patients with pulmonary arterial hypertension. The exploratory objective is to explore the effects of macitentan on PAH symptoms and their impact (as measured by the PAH-SYMPACT) in patients with pulmonary arterial hypertension.

    NCT ID:

    NCT01841762

    IRB Number:

    13-002142

    Who can I contact for additional information about this study?

    Rochester: Robert Frantz 507-284-2511
                        LuAnne Koenig (507) 284-4298
    Scottsdale: Robert L Scott 480-342-2376
                        Arcenio Galindo (480) 342-3987
    Jacksonville: Charles Burger 904-953-2000
                        Shannon Kennedy (904) 953-8557
  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. International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA)

    Rochester, Minn. View Summary

    International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA)

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    BACKGROUND: Evidence supporting a routine invasive practice paradigm for patients with stable ischemic heart disease (SIHD) is outdated. In strategy trials conducted in the 1970s, coronary artery bypass grafting (CABG) improved survival as compared with no CABG in SIHD patients with high-risk anatomic features. The relevance of these studies today is speculative because contemporary secondary prevention—aspirin, beta-blockers, statins, ACE inhibitors, and lifestyle interventions—were used minimally if at all. Subsequent trials have compared percutaneous coronary intervention (PCI) with medical therapy, as PCI has replaced CABG as the dominant method of revascularization for SIHD. To date, PCI has not been shown to reduce death or myocardial infarction (MI) compared with medical therapy in SIHD patients. COURAGE and BARI 2D, the two largest trials comparing coronary revascularization vs. medical therapy in SIHD patients, found that among patients selected on the basis of coronary anatomy after cath, an initial management strategy of coronary revascularization (PCI, PCI or CABG, respectively) did not reduce the primary endpoints of death or MI (COURAGE), or death (BARI 2D) compared with OMT alone. These data suggest, but do not prove, that routine cath--which often leads to ad hoc PCI through the diagnostic-therapeutic cascade--may not be required in SIHD patients. However, most patients enrolled in COURAGE and BARI 2D who had ischemia level documented at baseline had only mild or moderate ischemia, leaving open the question of the appropriate role of cath and revascularization among higher risk patients with more severe ischemia. Observational data suggest that revascularization of patients with moderate-to-severe ischemia is associated with a lower mortality than medical therapy alone, but such data cannot establish a cause and effect relationship. In clinical practice only about half such patients are referred for cath, indicating equipoise. Furthermore, analysis of outcomes for 468 COURAGE patients with moderate-to-severe ischemia at baseline did not reveal a benefit from PCI. This issue cannot be resolved using available data because all prior SIHD strategy trials enrolled patients after cath, introducing undefined selection biases (e.g., highest risk patients not enrolled) and making translation of study results problematic for clinicians managing patients who have not yet had cath. A clinical trial in SIHD patients uniformly at higher risk (which could not have been performed before COURAGE and BARI 2D results were available) is needed to inform optimal management for such patients. DESIGN NARRATIVE: The study protocol is final, and was distributed to sites February 2012. Study protocol v2.0 was approved in January 2014. PARTICIPATING COUNTRIES: North America - Canada - Mexico - USA (~150 sites) South America - Argentina - Brazil - Chile - Peru Asia - China - India - Japan - Singapore - Taiwan - Thailand - Russian Federation Pacifica - Australia - New Zealand Europe - Austria - Belgium - Denmark - France - Germany - Hungary - Italy - Lithuania - Macedonia - Netherlands - Poland - Portugal - Romania - Serbia - Spain - Sweden - UK Middle East - Israel - Saudi Arabia - Turkey

    NCT ID:

    NCT01471522

    IRB Number:

    12-007224

    Who can I contact for additional information about this study?

    Rochester: Todd Miller
                        


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