Cardiovascular drugs and therapy · 2025
Geranylgeranylacetone as Prevention for Postoperative Atrial Fibrillation (GENIALITY).
СтатьяПротокол клинического исследованияПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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S Ramos Kennedy, Nassiri Soufiane, Wijdeveld Leonoor F J, van der Palen Reinier L, Kuipers Myrthe F, Hills Mellanie True, Slijkerman Pieter, van Raalte Daniel H, Handoko M Louis, de Groot Natasja M S, Grewal Nimrat, Klautz Robert J M, Eringa Etto C, Brundel Bianca J J M
Аннотация
PURPOSE: 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 oral Geranylgeranylacetone (GGA) administration increased cardioprotective heat shock protein (HSP) protecting against AF onset and progression in clinically relevant animal model studies.
METHODS: The GENIALITY study is a phase II single-center, double-blind, placebo-controlled randomized trial comparing the efficacy of GGA in preventing PoAF. Participants (N = 146) are adult patients, without any registered history of AF, undergoing elective open-heart surgery for valvular disease, coronary artery bypass grafting, or concomitant, and are allocated with ratio 1:1 in treatment or placebo groups. Daily administration of 300 mg of GGA or placebo starts 5 days before until 3 days after surgery. Cardiac rhythm will be monitored using a Holter monitoring post-surgery until hospital discharge. Additionally, blood samples, right atrial appendage tissue, and epicardial adipose tissue will be collected to assess proteostasis levels.
RESULTS: The primary endpoint is the assessment of PoAF incidence in the GGA group compared to the placebo group. Secondary endpoints include the evaluation of HSP levels through biochemical analysis in both blood and atrial tissue.
CONCLUSION: The GENIALITY study aims to reduce PoAF incidence in the GGA group compared to the placebo group. Herewith, we expect to obtain proof of concept for a beneficial effect of GGA in preventing PoAF in patients undergoing cardiothoracic surgery. TRIAL REGISTRATION: Clinical Trial Information System (CTIS) registry: 2024-514743-28-00. Authorized on September 30th 2024.
METHODS: The GENIALITY study is a phase II single-center, double-blind, placebo-controlled randomized trial comparing the efficacy of GGA in preventing PoAF. Participants (N = 146) are adult patients, without any registered history of AF, undergoing elective open-heart surgery for valvular disease, coronary artery bypass grafting, or concomitant, and are allocated with ratio 1:1 in treatment or placebo groups. Daily administration of 300 mg of GGA or placebo starts 5 days before until 3 days after surgery. Cardiac rhythm will be monitored using a Holter monitoring post-surgery until hospital discharge. Additionally, blood samples, right atrial appendage tissue, and epicardial adipose tissue will be collected to assess proteostasis levels.
RESULTS: The primary endpoint is the assessment of PoAF incidence in the GGA group compared to the placebo group. Secondary endpoints include the evaluation of HSP levels through biochemical analysis in both blood and atrial tissue.
CONCLUSION: The GENIALITY study aims to reduce PoAF incidence in the GGA group compared to the placebo group. Herewith, we expect to obtain proof of concept for a beneficial effect of GGA in preventing PoAF in patients undergoing cardiothoracic surgery. TRIAL REGISTRATION: Clinical Trial Information System (CTIS) registry: 2024-514743-28-00. Authorized on September 30th 2024.