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NCT01900600 Clinical Trial

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)

Evidence of Systemic Inflammation (C Reactive Protein Plasma >2 mg/l) Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01900600
Other study ID # HM13782
Secondary ID 20110521
Status Completed
Phase N/A
First received
Last updated
Start date April 2013
Est. completion date January 8, 2015

Study information
Verified date October 2018
Source Virginia Commonwealth University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date January 8, 2015
Est. primary completion date January 8, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 110 Years
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

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.
• Echocardiogram
An echocardiogram (ultrasound of the heart) will be performed prior to initiation of treatment and then again 12 months later.

Locations
Country Name City State
United States Virginia Commonwealth University Richmond Virginia

Sponsors (2)
Lead Sponsor Collaborator
Virginia Commonwealth University Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (2)

Abbate A, Van Tassell BW, Biondi-Zoccai GG. Blocking interleukin-1 as a novel therapeutic strategy for secondary prevention of cardiovascular events. BioDrugs. 2012 Aug 1;26(4):217-33. doi: 10.2165/11631570-000000000-00000. Review. — View Citation

Ridker PM, Thuren T, Zalewski A, Libby P. Interleukin-1ß inhibition and the prevention of recurrent cardiovascular events: rationale and design of the Canakinumab Anti-inflammatory Thrombosis Outcomes Study (CANTOS). Am Heart J. 2011 Oct;162(4):597-605. doi: 10.1016/j.ahj.2011.06.012. Epub 2011 Sep 14. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Peak oxygen consumption (VO2) 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). 3 months
Secondary Peak VO2 change Difference in the interval changes from baseline and 12 months in peak VO2 comparing CANAKINUMAB (all doses) with placebo 12 months
Secondary Ventilatory efficiency (VE/VCO2 slope) change Difference in the interval changes from baseline and 3 months in the VE/VCO2 slope comparing CANAKINUMAB (all doses) with placebo 12 months
Secondary OUES Difference in the interval changes from baseline and 12 months in oxygen utilization efficiency slope (OUES) comparing CANAKINUMAB (all doses) with placebo 12 months
Secondary LVEF change Difference in the interval changes from baseline and 12 months in left ventricular ejection fraction (LVEF) comparing CANAKINUMAB (all doses) with placebo 12 months
Secondary Diastolic function change Difference in the interval changes from baseline and 12 months in E/E' (diastolic function) comparing CANAKINUMAB (all doses) with placebo 12 months

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