Evidence map›Paper›PMID 40227474›Full record

ArticleCardiovascular drugs and therapy2025

Geranylgeranylacetone as Prevention for Postoperative Atrial Fibrillation (GENIALITY).

Kennedy S Ramos, Soufiane Nassiri, Leonoor F J Wijdeveld, Reinier L van der Palen, Myrthe F Kuipers, Mellanie True Hills, Pieter Slijkerman, Daniel H van Raalte, M Louis Handoko, Natasja M S de Groot and 4 more

Abstract readClinical Trial Protocol
In one paragraph

Article in Cardiovascular drugs and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Kennedy S RamosAmsterdam Cardiovascular Sciences, Heart Failure and Arrhythmias, Amsterdam University Medical Center, Location Vrije Universiteit Amsterdam, De Boelelaan 1117, Physiology, 1081 HV Amsterdam, The Netherlands. k.silvaramos@amsterdamumc.nl.ORCID 0000-0002-0283-3765
Soufiane NassiriDepartment of Cardiology, Amsterdam University Medical Center, Amsterdam, The Netherlands.
Leonoor F J WijdeveldAmsterdam Cardiovascular Sciences, Heart Failure and Arrhythmias, Amsterdam University Medical Center, Location Vrije Universiteit Amsterdam, De Boelelaan 1117, Physiology, 1081 HV Amsterdam, The Netherlands.
Reinier L van der PalenAmsterdam Cardiovascular Sciences, Heart Failure and Arrhythmias, Amsterdam University Medical Center, Location Vrije Universiteit Amsterdam, De Boelelaan 1117, Physiology, 1081 HV Amsterdam, The Netherlands.
Myrthe F KuipersAFIP Foundation, Amsterdam, The Netherlands.
Mellanie True HillsStopafib.Org, American Foundation for Women'S Health, Decatur, TX, USA.
Pieter SlijkermanInnovation Exchange Amsterdam, Amsterdam University Medical Center, Amsterdam, The Netherlands.
Daniel H van RaalteDiabetes Center, Department of Internal Medicine, Amsterdam University Medical Center, Amsterdam, The Netherlands.
M Louis HandokoDepartment of Cardiology, Amsterdam University Medical Center, Amsterdam, The Netherlands.
Natasja M S de GrootDepartment of Cardiology, Erasmus Medical Center, Rotterdam, The Netherlands.
Nimrat GrewalDepartment of Cardiothoracic Surgery, Amsterdam University Medical Center, Amsterdam, The Netherlands.
Robert J M KlautzDepartment of Cardiothoracic Surgery, Amsterdam University Medical Center, Amsterdam, The Netherlands.
Etto C EringaAmsterdam Cardiovascular Sciences, Heart Failure and Arrhythmias, Amsterdam University Medical Center, Location Vrije Universiteit Amsterdam, De Boelelaan 1117, Physiology, 1081 HV Amsterdam, The Netherlands.
Bianca J J M BrundelAmsterdam Cardiovascular Sciences, Heart Failure and Arrhythmias, Amsterdam University Medical Center, Location Vrije Universiteit Amsterdam, De Boelelaan 1117, Physiology, 1081 HV Amsterdam, The Netherlands. b.brundel@amsterdamumc.nl.

Funding

Netherlands Heart Foundation 2020B008Netherlands Heart Foundation CVON RECONNEXTNWO NWA 1389.20.157
6 · The paper itself

Abstract

purposeInterestingly, 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.

methodsThe 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.

resultsThe 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.

conclusionThe 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 registrationClinical Trial Information System (CTIS) registry: 2024-514743-28-00. Authorized on September 30th 2024.

Indexed as

Anti-Arrhythmia AgentsAtrial FibrillationCardiac Surgical ProceduresDiterpenesHeart RatePostoperative ComplicationsClinical Trials, Phase II as TopicDouble-Blind MethodFemaleHumansIncidenceMaleMiddle AgedRandomized Controlled Trials as TopicTime FactorsTreatment OutcomeAnti-Arrhythmia AgentsDiterpenesgeranylgeranylacetoneCardiothoracic surgeryHeat shock proteinsPostoperative atrial fibrillationPrevention

Identifiers

PMID40227474
PMCPMC12717209

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.