drugset / Trial / NCT01999829

Prevention of Atrial Fibrillation Following Valvular Replacement With Cardiopulmonary Bypass: a Prospective, Randomized Clinical Study Comparing Oral Caffeine With Placebo

NCT01999829

Phase 3 Completed 110 enrolled Assistance Publique Hopitaux De Marseille
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Atrial fibrillation remains a major cause of morbidity following cardiac surgery with cardiopulmonary bypass. Many mechanisms have been implicated. Among then, adenosine, a strong endogenous vasodilating agent has been involved in cardiac surgery-induced atrial fibrillation, via A2A receptors modulation. The effects of caffeine on the inducibility of atrial fibrillation are actually well-known, leading then to a significant reduction of atrial fibrillation. Moreover, a recent clinical study has demonstrated that coffee drinking was inversely associated with total and cause-specific mortality. The investigators therefore examined the preventive effects of oral caffeine on valvular surgery with cardiopulmonary bypass-induced atrial fibrillation. The investigators also evaluated prospectively the influence of caffeine on adenosine plasma levels and A2A adenosine receptors modulation.

Timeline

Start
2013-10
Primary completion
2016-06
Completion
2016-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Caffeine Small molecule 400 mg Oral

Indications