NCT01900600

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)

Substudy of the the CANTOS Trial (Interleukin-1 Blockade With Canakinumab to Improve Exercise Capacity in Patients With Chronic Systolic Heart Failure and Elevated Hs-CRP; CACZ885M2301)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 18 Years – 110 Years
• Healthy volunteers: Not accepted

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 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.

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 fraction (LVEF\<50%) and are symptomatic for heart failure (New York Heart Association symptoms class II-III) will be offered to take part in this sub-study at the Virginia Commonwealth University site. As part of the sub-study, patients will undergo a cardiopulmonary exercise test (CPX) at baseline prior to initiation of treatment, then repeated at 3 and 12 months, and a transthoracic echocardiogram at baseline and at 12 months.

Conditions

• 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)

Interventions

Type	Name	Description
OTHER	Cardiopulmonary exercise test	All patients will undergo a first CPX prior to initiation of treatment, a second one after 3 months, and a third one after 12 months of treatment.
OTHER	Echocardiogram	An echocardiogram (ultrasound of the heart) will be performed prior to initiation of treatment and then again 12 months later.

Timeline

• Start date: 2013-04-01
• Primary completion: 2015-01-08
• Completion: 2015-01-08
• First posted: 2013-07-16
• Last updated: 2018-10-10

Locations

1 site across 1 country: United States