Randomized Interventional Clinical Trial on the Prevention of Atrial Fibrillation Using Colchicine, Amiodarone And a Posterior Pericardiotomy.

Condition(s) studied

Investigational drug(s) / intervention(s)

Colchicine: The dosage will be 1mg PO on D-1, followed by 1mg/day PO from D1 to D5 (stopped in case of diarrhoea). This represents a maximum total dose of 6mg. If the patient is older than 75 years old or if the patient's weight is less than 70kg, then the daily dosage will be 0.5mg.

Amiodarone: 400mg/day per os (PO) on D-1 and D0, followed by 200mg/day PO from D1 to D5 if the heart rate is equal or superior to 70 beats/min. If the heart rate is inferior to 70 beats/min then the treatment will not be given. This represents a maximum total dose of 1800mg.

Posterior pericardiotomy: The procedure will be done similarly to previously published studies (Mulay et al. 1995; Gaudino et al. 2021). The left pleural space will be entered through the pre-existing median sternotomy. A 4-cm incision will be made posterior to the phrenic nerve in a parallel and longitudinal fashion extending from the left inferior pulmonary vein to the diaphragm. We will use the tip of the mediastinal tube that is placed in all cardiac surgery patients (instead of an additional chest tube) for drainage of the left-sided pleura so that patients in the treatment group will not have a higher level of postoperative pain or discomfort. The estimated additional surgery time is less than 5 min (Abouarab et al. 2017).

Study summary

The goal of this clinical trial is to learn if a bundle of three treatments can prevent atrial fibrillation, a heart rhythm disorder often observed in adults following heart surgery. Atrial fibrillation is associated with increased risks of stroke and heart failure. The bundle consists of two drugs (colchicine and amiodarone) as well as a simple surgical technique called posterior pericardiotomy. The main question it aims to answer is whether this bundle can reduce the incidence of atrial fibrillation after heart surgery.

Researchers will compare the results from this bundle of treatment to two other groups, one treated only with the posterior pericardiotomy and one treated following standard of care.

Participants, depending on their group, may receive colchicine and amiodarone before and just after heart surgery and the posterior pericardiotomy will be performed at the same time as the heart surgery.

Eligibility

Primary outcome measure(s)

• Difference in the number of patients presenting an episode of persistent AF between control group and the two experimental groups — From enrollment to seven days after the surgery
  The primary endpoint is the difference in the number of patients presenting an episode of persistent AF (defined as an AF episode lasting more than 30 minutes as documented by scopic and telemetric monitoring) during their hospitalisation. AF is defined by the ESC as RR interval irregularity, absence of repeated P waves, and irregular atrial activations. The SoC group will be compared to the other two groups of the study. Any episode of persistent AF will be recorded by the usual telemetric monitoring used in post-cardiac surgery monitoring and confirmed by a specialist's review of the trace.

Trial sites (3)

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