Heart Failure Clinical Trial
PROCLAIM: Effect of AC2592 Administered by Continuous Subcutaneous Infusion in Subjects With Advanced Chronic Congestive Heart Failure
Summary
This Phase 2, randomized, placebo-controlled, multicenter outpatient study is designed to test the safety and tolerability of AC2592 as well as examine the effect of AC2592 on oxygen consumption during maximal tolerated exercise in adult subjects with chronic congestive heart failure.
Eligibility Criteria
Main Inclusion Criteria:
Has heart failure classified as New York Heart Association (NYHA) Class III or Class IV at screening despite treatment with standard therapy.
Is able to perform a treadmill test.
Has an HbA1c of <= 11%.
Is physically and mentally capable of operating the continuous subcutaneous infusion (CSCI) pump (i.e., adequate vision, manual dexterity, and mental capacity), or has a dedicated caretaker or adult family member who meets this requirement.
Main Exclusion Criteria:
Has received metformin or nesiritide within 2 weeks prior to screening visit.
Is currently participating in any other clinical study, or has received an investigational drug within 1 month of the screening period.
Has participated previously in a study using GLP-1, exenatide, or exenatide LAR.
Is using a left ventricular assist device or other mechanical circulatory support.
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There is 1 Location for this study
Beverly Hills California, , United States
Mission Viejo California, , United States
New Haven Connecticut, , United States
Washington District of Columbia, , United States
Jacksonville Florida, , United States
Tampa Florida, , United States
Peoria Illinois, , United States
Springfield Illinois, , United States
Winfield Illinois, , United States
Wichita Kansas, , United States
Baton Rouge Louisiana, , United States
Shreveport Louisiana, , United States
Auburn Maine, , United States
Boston Massachusetts, , United States
Detroit Michigan, , United States
Lincoln Nebraska, , United States
Chapel Hill North Carolina, , United States
Durham North Carolina, , United States
Cincinnati Ohio, , United States
Cleveland Ohio, , United States
Columbus Ohio, , United States
Oklahoma City Oklahoma, , United States
Medford Oregon, , United States
Portland Oregon, , United States
Philadelphia Pennsylvania, , United States
Charleston South Carolina, , United States
Knoxville Tennessee, , United States
Dallas Texas, , United States
Houston Texas, , United States
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