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)
Completed · Not applicable · Has a placebo group
Conditions studied: Prior Acute Myocardial Infarction, Evidence of Systemic Inflammation (C Reactive Protein Plasma >2 mg/l), Reduced Left Ventricle Ejection Fraction (<50%), Symptoms of Heart Failure (NYHA Class II-III)
In brief
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 cardiovascular events among stable post-myocardial infarction patients with elevated high sensitivity C-reaction protein (hsCRP) \[CACZ885M2301\]). The study proposes to perform serial Cardiopulmonary Exercise Tests (CPX) to prospectively measure changes in aerobic exercise capacity in patients with prior myocardial infarction (MI), elevated C reactive protein plasma levels, and symptomatic heart failure with reduced systolic function, who are enrolled in the main CANTOS trial and are randomly assigned to Canakinumab (3 different doses) or Placebo. The subjects enrolled in this substudy will undergo repeated CPX and echocardiograms over the first 12 months of the CANTOS trial. The subjects will received the experimental treatment as randomized in the main CANTOS trial and they will not receive any additional experimental treatment as part of the sub-study. This study is a an Investigator-initiated (Dr. Abbate) single-center (Virginia Commonwealth University) sub-study of the CANTOS trial, supported by Novartis pharmaceuticals.
Key facts
- Study ID
- NCT01900600
- Run by
- Virginia Commonwealth University
- People needed
- 15
- Starts
- 2013-04-01
- Expected to finish
- 2015-01-08
- Last updated by the study team
- 2018-10-10
Who can join
Age: 18 and older, up to 110. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- all criteria listed in the CANTOS trial (CACZ885M2301)
- left ventricular ejection fraction <50%
- symptoms of heart failure (NYHA class II-III)
You may not qualify if…
- 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)
Where it is running
- Virginia Commonwealth University — Richmond, Virginia, United States
Full record on ClinicalTrials.gov
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