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Heart Failure clinical trials at UC Davis
4 research studies open to eligible people

  • A Study of the Experimental MitraClip Device for Heart Failure With Functional Mitral Regurgitation (backflow of blood)

    open to eligible people ages 18 years and up

    The purpose of the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) Trial is to confirm the safety and effectiveness of the MitraClip System for the treatment of moderate-to-severe or severe functional mitral regurgitation (FMR) in Symptomatic Heart Failure Subjects who are treated per standard of care and who have been determined by the site's local heart team as not appropriate for mitral valve surgery. This randomized controlled trial will provide the opportunity to strengthen or add labeling claims regarding safety and clinical benefits of the MitraClip System for symptomatic heart failure patients with moderate-to-severe or severe functional mitral regurgitation. Approximately 610 subjects will be randomized at up to 100 investigational sites with approximately 305 subjects targeted to receive the study device. COAPT study completed recruiting subjects in June 2017. As part of the COAPT trial, a subset of patients will be registered in the cardiopulmonary exercise (CPX) sub-study. The objective of this sub-study is to evaluate the exercise responses in a sub-cohort of COAPT subjects who receive MitraClip device (Device group) compared to the Control group who do not receive MitraClip device. (Note: the CPX Sub-study subjects will contribute to the analyses of the COAPT primary and secondary endpoints) As an extension of the COAPT RCT trial, COAPT CAS study will be conducted after COAPT enrollment is complete under the same investigational device exemption (IDE(G120024)). The objective of this study is to evaluate the MitraClip® NT System for the treatment of clinically significant functional mitral regurgitation (FMR) in symptomatic heart failure subjects who are treated per standard of care and who have been determined by the site's local heart team as not appropriate for mitral valve surgery. The anticipated study Primary Completion date is July 2018 and the Study Completion Date is July 2024. COAPT CAS is presently recruiting subjects.

    Sacramento, California and other locations

  • Oral Treprostinil in Subjects With Pulmonary Hypertension (PH) Associated With Heart Failure With Preserved Ejection Fraction (...

    open to eligible people ages 18-85

    This is a multicenter, randomized (1:1; oral treprostinil to placebo), double-blind, placebo-controlled study in subjects with World Health Organization (WHO) Group 2 pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (HFpEF). Once randomized, subjects will take the initial dose of study drug at the study site on the day of randomization. Subjects will return to the study site for visits scheduled at Weeks 6, 12, 18, and 24. The treatment phase of the study will last approximately 24 weeks.

    Sacramento, California and other locations

  • Study of high dose/low dose influenza vaccine to effectively stop heart or lung-related problems

    “Does high-dose influenza (“flu”) vaccine safely reduce heart or lung-related problems compared to the standard-dose flu vaccine?”

    open to eligible people ages 18 years and up

    INVESTED will test the hypothesis that high dose trivalent influenza vaccine will reduce cardiopulmonary events to a greater extent than standard dose quadrivalent influenza vaccine in high-risk cardiovascular patients with a recent history of myocardial infarction or heart failure. The trial will enroll 9300 participants over one Vanguard (pilot) season and three additional influenza seasons. The primary endpoint will be a composite of all-cause mortality or cardiopulmonary hospitalization.

    Sacramento, California and other locations

  • Treatment of Heart Failure and Mitral Valve Regurgitation (backflow of blood in the heart) With the Experimental MVRx Arto System

    “This study will assess the safety and function of a new mitral valve repair system called the Arto System.”

    open to eligible people ages 18 years and up

    The objective of the study is to evaluate the safety and performance of the ARTO System in patients with mitral valve regurgitation (MR) associated with congestive heart failure (CHF).

    Brighton, and other locations

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