Clinical Trials

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2 studies in Division of Cardiovascular Diseases in Phoenix/Scottsdale, AZ.

  1. 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., Jacksonville, Fla., Rochester, Minn. 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., Jacksonville, Fla., Rochester, Minn.

    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: Beth Kaping, RN 507-255-7962
                        Sarah Shonyo 507-255-2648
    Scottsdale: Barbara Knight 480-342-2545
                        
    Jacksonville: Estela Staggs 904-953-8509
                        
  2. Aquapheresis Versus Intravenous Diuretics and Hospitalizations for Heart Failure (AVOID-HF)
    Phoenix/Scottsdale, Ariz. View Summary

    Aquapheresis Versus Intravenous Diuretics and Hospitalizations for Heart Failure (AVOID-HF)

    Location:

    Phoenix/Scottsdale, Ariz.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The aim of the proposed AVOID-HF study is to confirm and expand the findings that fluid removal by AQ reduces HF rehospitalizations at 90 days as well as the length of these HF rehospitalizations. In the "Ultrafiltration Versus Intravenous Diuretics for Patients Hospitalized for Acute Decompensated Heart Failure" (UNLOAD) study, the 90 day HF re-hospitalizations were pre-specified secondary end-points. AVOID-HF is designed with a primary end-point to determine if AQ reduces the number of HF events (Rehospitalization or unscheduled outpatient or emergency room treatment for HF) after discharge from index hospitalization compared to IV loop diuretics. AVOID will also explore days alive and out of the hospital as a secondary end-point, which was not done in UNLOAD. In other words, the AVOID-HF study is going beyond studying only the amount of fluid removal and will explore whether the modality of fluid removal influences HF outcomes.

    NCT ID:

    NCT01474200

    IRB Number:

    12-008941

    Who can I contact for additional information about this study?


    Scottsdale: Eric Steidley, M.D. 480-342-2382
                        Stefanie Velgos (480) 342-3987