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)
| Status: | Completed |
|---|---|
| Conditions: | Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 110 |
| Updated: | 10/12/2018 |
| Start Date: | April 2013 |
| End Date: | January 8, 2015 |
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)
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.
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.
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.
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.
Inclusion Criteria:
- all criteria listed in the CANTOS trial (CACZ885M2301)
- left ventricular ejection fraction <50%
- symptoms of heart failure (NYHA class II-III)
Exclusion Criteria:
- 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)
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Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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