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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01999829

Enrollment

110

Registered

2013-12-03

Start date

2013-10-31

Completion date

2016-06-30

Last updated

2017-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Brief 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.

Interventions

DRUGcitrate of caffeine

DRUGplacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Age = 18 years * Surgery valvular settled(adjusted) (plasties or aortic replacement, mitral, tricuspid or mixed), under CEC * Period of weaning in caffeine: limitation of the consumption of coffee(café), tea, chocolate, in a cup the day before the intervention * Consent of the patients after information

Exclusion criteria

* Pregnant or breast-feeding women * Women taking an oral contraception (half-life of the caffeine increased until 3 times) * Minors(miners) or adults under guardianship * Persons staying in a sanitary or social establishment * Not profitable persons of a national insurance scheme * Private persons of freedom * Persons requiring a surgery of replacement valvular as a matter of urgency * Patients having been treated(handled) by papaverine, dipyridamole, corticoids, immunosuppressors or antibiotics during six weeks preceding the date of inclusion * Weighty patient lower than 50 kg or upper to 100 kg or having a body mass index upper to 29 Kg / m2 * Presence of an active infection, a chronic inflammatory pathology, a lung arterial high blood pressure

Design outcomes

Primary

Measure	Time frame
Decrease of 50 % of the incidence of atrial fibrillation	24 MONTHS

Secondary

Measure	Time frame
decrease in the use of anti-arrhythmic resuscitation	24 MONTHS

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026