Status:
COMPLETED
Interleukin-1 Blockade With Canakinumab to Improve Exercise Capacity in Patients With Chronic Systolic Heart Failure and Elevated High Sensitivity C-reactive Protein (Hs-CRP)
Lead Sponsor:
Virginia Commonwealth University
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Prior Acute Myocardial Infarction
Evidence of Systemic Inflammation (C Reactive Protein Plasma >2 mg/l)
Eligibility:
All Genders
18-110 years
Phase:
NA
Brief Summary
The proposed study is a sub-study of the CANTOS trial (A randomized, double-blind, placebo-controlled, event driven trial of quarterly subcutaneous canakinumab in the prevention of recurrent cardiovas...
Detailed Description
Patients enrolled in the CANTOS trial (with prior acute myocardial infarction \[\>30 days\] and elevated C reactive protein levels \[CRP\>2mg/l\]) who also have reduced left ventricular ejection fract...
Eligibility Criteria
Inclusion
- all criteria listed in the CANTOS trial (CACZ885M2301)
- left ventricular ejection fraction \<50%
- symptoms of heart failure (NYHA class II-III)
Exclusion
- all criteria listed in the CANTOS trial (CACZ885M2301)
- inability to complete a treadmill exercise test
- conditions preventing interpretation of the cardiopulmonary test (arrhythmias, ischemia, hypertension, pulmonary disease)
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 8 2015
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01900600
Start Date
April 1 2013
End Date
January 8 2015
Last Update
October 10 2018
Active Locations (1)
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1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298