The GENIALITY trial is a phase II randomized study designed to evaluate whether oral geranylgeranylacetone (300 mg daily) reduces postoperative atrial fibrillation in 146 patients.
RCT (n=146)
Double-blind
1:1
No
Does oral geranylgeranylacetone prevent postoperative atrial fibrillation in adult patients undergoing elective open-heart surgery?
The GENIALITY trial is a phase II study designed to evaluate whether prophylactic oral geranylgeranylacetone can reduce the incidence of postoperative atrial fibrillation in patients undergoing elective open-heart surgery.
Abstract Introduction Atrial fibrillation (AF) is the most common cardiac arrhythmia. Interestingly 30-50% of patients undergoing elective cardiothoracic surgery develop postoperative AF (PoAF). Unfortunately, preventive PoAF therapy is still suboptimal. In our previous studies we showed that cardioprotective heat shock protein (HSP) levels are increased by oral GeranylGeranylAcetone (GGA) administration. In line, GGA treatment protects against AF onset and progression in clinically relevant animal model studies. Purpose To evaluate whether oral administration of GGA protects against incidence of PoAF on patients undergoing elective cardiothoracic surgery. Methods The trial is a phase II single-center, double-blind, placebo-controlled randomized trial. Participants (N=146) are adult patients, without any registered history of AF, undergoing elective open-heart surgery for mitral and/or valve repair, and/or coronary artery bypass grafting, are allocated with ratio 1:1 in treatment or placebo groups. Daily administration of 300mg of GGA or placebo starts five days before until three days after surgery. In order to assess cardiac rhythm, as primary endpoint, bedside cardiac monitoring is performed after surgery until hospital discharge. The patients undergo blood, right atrial appendage and epicardial adipose tissue sampling in order to assess proteostasis levels, as secondary endpoints. Conclusions The trial aims to reduce PoAF incidence in GGA group compared to placebo group, by increase of cardioprotective HSPs. Herewith, we expect to obtain proof of concept for a beneficial effect of GGA in preventing PoAF in patients undergoing cardiothoracic surgery.
Ramos et al. (Sat,) conducted a rct in Postoperative Atrial Fibrillation (n=146). Geranylgeranylacetone (GGA) vs. Placebo was evaluated on Incidence of postoperative atrial fibrillation assessed by bedside cardiac monitoring until hospital discharge. The GENIALITY trial is a phase II randomized study designed to evaluate whether oral geranylgeranylacetone (300 mg daily) reduces postoperative atrial fibrillation in 146 patients.