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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)

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ClinicalTrials.gov Identifier: NCT01900600
Recruitment Status : Completed
First Posted : July 16, 2013
Last Update Posted : October 10, 2018
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Virginia Commonwealth University

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 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.


Condition or disease Intervention/treatment Phase
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) Other: Cardiopulmonary exercise test Other: Echocardiogram Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: 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)
Study Start Date : April 2013
Actual Primary Completion Date : January 8, 2015
Actual Study Completion Date : January 8, 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Canakinumab

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo
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 Name: Cardiopulmonary exercise test (CPX)

Other: Echocardiogram
An echocardiogram (ultrasound of the heart) will be performed prior to initiation of treatment and then again 12 months later.
Other Name: Echocardiogram or Echo

Active Comparator: Canakinumab 50 mg quarterly
Canakinumab 50 mg quarterly
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 Name: Cardiopulmonary exercise test (CPX)

Other: Echocardiogram
An echocardiogram (ultrasound of the heart) will be performed prior to initiation of treatment and then again 12 months later.
Other Name: Echocardiogram or Echo

Active Comparator: Canakinumab 150 mg quarterly
Canakinumab 150 mg quarterly
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 Name: Cardiopulmonary exercise test (CPX)

Other: Echocardiogram
An echocardiogram (ultrasound of the heart) will be performed prior to initiation of treatment and then again 12 months later.
Other Name: Echocardiogram or Echo

Active Comparator: Canakinumab 300 mg quarterly
Canakinumab 300 mg quarterly
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 Name: Cardiopulmonary exercise test (CPX)

Other: Echocardiogram
An echocardiogram (ultrasound of the heart) will be performed prior to initiation of treatment and then again 12 months later.
Other Name: Echocardiogram or Echo




Primary Outcome Measures :
  1. Peak oxygen consumption (VO2) [ Time Frame: 3 months ]
    Difference in the interval change from baseline in peak VO2 at 3 months following a single dose of CANAKINUMAB 50 mg subcutaneous, 150 mg subcutaneous, or CANAKINUMAB 300 mg subcutaneous [all three groups combined] when compared with the interval change in placebo (placebo-corrected interval change).


Secondary Outcome Measures :
  1. Peak VO2 change [ Time Frame: 12 months ]
    Difference in the interval changes from baseline and 12 months in peak VO2 comparing CANAKINUMAB (all doses) with placebo

  2. Ventilatory efficiency (VE/VCO2 slope) change [ Time Frame: 12 months ]
    Difference in the interval changes from baseline and 3 months in the VE/VCO2 slope comparing CANAKINUMAB (all doses) with placebo

  3. OUES [ Time Frame: 12 months ]
    Difference in the interval changes from baseline and 12 months in oxygen utilization efficiency slope (OUES) comparing CANAKINUMAB (all doses) with placebo

  4. LVEF change [ Time Frame: 12 months ]
    Difference in the interval changes from baseline and 12 months in left ventricular ejection fraction (LVEF) comparing CANAKINUMAB (all doses) with placebo

  5. Diastolic function change [ Time Frame: 12 months ]
    Difference in the interval changes from baseline and 12 months in E/E' (diastolic function) comparing CANAKINUMAB (all doses) with placebo



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01900600


Locations
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United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Novartis Pharmaceuticals
Investigators
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Principal Investigator: Antonio Abbate, MD, PhD Virginia Commonwealth University

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01900600     History of Changes
Other Study ID Numbers: HM13782
20110521 ( Other Identifier: WIRB )
First Posted: July 16, 2013    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
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Heart Failure
Myocardial Infarction
Heart Failure, Systolic
Inflammation
Infarction
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Ischemia
Necrosis
Myocardial Ischemia
Vascular Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs