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)
Condition: 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)
MeSH terms: Heart Failure; Myocardial Infarction; Heart Failure, Systolic; Inflammation; Infarction
Study type: Interventional

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.
    

Intervention name(s): Cardiopulmonary exercise test; Echocardiogram
Intervention type(s): Other; Other
Intervention description(s): 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.; An echocardiogram (ultrasound of the heart) will be performed prior to initiation of treatment and then again 12 months later.
Other intervention name(s): Cardiopulmonary exercise test (CPX); Echocardiogram or Echo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other