Canakinumab for the Prevention of Recurrences After Electrical Cardioversion: CONVERT-AF (CONVERT-AF)

Canakinumab for the Prevention of Recurrences After Electrical Cardioversion in Patients With Persistent Atrial Fibrillation (CONVERT-AF) Trial - A Randomized Double Blind Placebo Controlled Study

The purpose of this study is to test the efficacy of a single injection of Canakinumab on AF recurrences within 6 months after electrical cardioversion in patients with persistent AF.

Study Overview

• Status: Terminated
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Biological: Placebo; Biological: Canakinumab

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany
    • University Heart Center Hamburg
• Switzerland
  • Basel, Switzerland, 4031
    • Department of Medicine, University Hospital
  • Geneve, Switzerland
    • HUG Geneve
  • Lausanne, Switzerland
    • CHUV Lausanne
  • St. Gallen, Switzerland
    • Kantonsspital St. Gallen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• EKG-documented AF
• Undergoing electrical cardioversion
• C-reactive protein ≥1.25mg/L
• Age ≥ 50 years, women need to be postmenopausal

Exclusion Criteria:

• Undergoing urgent cardioversion because of medical instability
• AF persistence after cardioversion or AF recurrence before randomization
• Atrial flutter
• Severe renal failure (creatinine clearance <30 ml/min)
• Known active or recurrent hepatic disorder (including cirrhosis, hepatitis A, B or C, or Alanine transaminase/aspartate aminotransferase levels >3x ULN or total bilirubin >2x ULN)
• History of malignancy other than basal cell skin carcinoma
• Known intolerance or allergic reactions to canakinumab
• Use of amiodarone within the last 6 months
• Known HIV or any other immune compromised state including neutropenia or immunodeficiency
• History of ongoing, chronic or recurrent infectious disease

• History or evidence of active tuberculosis (TB) infection at Visit 1 or one of the risk factors for tuberculosis such as but not limited or exclusive to:

  • History of any of the following: residence in a congregate setting (e.g. jail or prison, homeless shelter, or chronic care facility), substance abuse (e.g. injection or noninjection), health-care workers with unprotected exposure to patients who are at high risk of TB or patients with TB disease before the identification and correct airborne precautions of the patient.
  • Close contact (i.e. share the same air space in a household or other enclosed environment for a prolonged period (days or weeks, not minutes or hours)) with a person with active pulmonary TB disease within the last 12 months.
  • Evidence of tuberculosis infection, at Visit 1, determined as defined by local guidelines/ local medical practice (see also below for determination of tuberculosis status). If presence of tuberculosis is established then treatment (according to local guidelines) must have been completed prior to randomization. Completion of treatment is determined by local TB guidelines or in the absence of such guidelines the following has to be demonstrated: TB has been treated adequately with antibiotics, cure can be demonstrated, and risk factors resulting in TB exposure and contracting TB have been removed (e.g. the patient does not live anymore in high TB exposure setting).
• Patients on systemic corticosteroids or other anti-inflammatory drugs other than non-steroidal anti-inflammatory drugs
• Patients on any biological drug targeting the immune system
• Acute coronary syndrome or acute stroke within 3 months
• History of heart failure hospitalization within 3 months
• Planned major surgery including planned coronary artery bypass grafting
• Women of childbearing potential
• Live vaccinations within 3 months prior to the randomization visit (visit 2) or live vaccinations planned during the trial.
• Life expectancy <1 year
• Inability to comply with the study protocol
• Previously enrolled in CONVERT-AF
• Patients who have received an investigational drug or device within 30 days of first visit.
• History of alcohol and/or substance abuse that could interfere with the conduct of the trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Canakinumab; 1 s.c. injection of canakinumab 150mg directly after cardioversion	Biological: Canakinumab
Placebo Comparator: Placebo; 1 s.c. injection directly after cardioversion	Biological: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Recurrence of atrial fibrillation	180 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Recurrence of atrial fibrillation	90 days
Change in plasma levels of C-reactive protein	180 days
Time to first redo cardioversion	180 days

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: David Conen, Prof., Cardiology, University Hospital Basel

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: March 5, 2013
• First Submitted That Met QC Criteria: March 5, 2013
• First Posted (Estimate): March 6, 2013

Study Record Updates

• Last Update Posted (Actual): February 14, 2017
• Last Update Submitted That Met QC Criteria: February 13, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Arrhythmias, Cardiac; Atrial Fibrillation; Recurrence
• Other Study ID Numbers: CONVERT-AF Version5 22.01.2013