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The Patient-Funded GENIALITY Trial Has Approval to Start Recruiting

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Can GeranylGeranylAcetone (GGA) prevent Development of Atrial Fibrillation?

December 1, 2024

  • Summary: The Patient-Funded GENIALITY Trial of GGA for preventing atrial fibrillation is ready to start recruiting.
  • Reading time:  4–5 minutes

Professor Dr. Bianca Brundel, from the Amsterdam University Medical Center in the Netherlands, is a favorite presenter at the Get in Rhythm. Stay in Rhythm ® Atrial Fibrillation Patient Conference each year.

She is at the leading edge of practical basic science research for afib. At the conference, she provides updates on her afib patient-driven research and gives actionable ways to help manage afib. She has shared information on testing how toxic triggers drive afib progression and how those findings will be used to discover effective treatments and diagnostics. She has discussed patient involvement in research, including how to get involved.

Dr. Brundel founded the nonprofit Atrial Fibrillation Innovation Platform, which promotes studies in collaboration with patients, and leads the CIRCULAR project funded by the Dutch government based on co-creating research with afib patients and StopAfib.org.

We have learned so much from her. Thus, we in the afib patient community stepped up a few years ago to help fund some of Dr. Brundel’s patient-focused research.

GENIALITY Atrial Fibrillation Trial

Dr. Brundel and her colleagues showed that structural damage to the heart results from “derailment in cardiomyocyte proteostasis” and that heat shock proteins (HSPs) could counteract this damage.

A potent drug called GGA (geranylgeranylacetone) can induce heat shock proteins in the heart. In a dog model of afib, they showed that oral treatment with the drug GGA prevents damage and protects against afib onset and progression.

GGA is a non-toxic HSP-inducer, and since 1984, it has been registered in several Asian countries to treat gastric ulcers. GGA also protects against afib progression and accelerates recovery from damage in experimental afib models. In addition, three days of oral treatment with GGA induces HSP levels in the atrial tissue of patients undergoing cardiac surgery. The researchers believe oral treatment with GGA can reverse afib-induced damage and prevent post-operative afib (POAF) from cardiac surgery.

With our help as a patient community, they will study the effect of GGA on the development of afib. The primary objective will be to determine if the HSP-inducing and protective effects of GGA can prevent the development of new afib in patients who have elective cardiac bypass surgery. Afib damages the heart through structural and electrical remodeling. Thus, the secondary objectives are to assess the protective effects of GGA on damage by quantifying the amount of structural and electrical remodeling. This will be done by determining the amount of arrhythmogenic substrate using high-resolution mapping during open-heart surgery. They will also determine the duration and number of POAF episodes (afib burden).

If this non-toxic, well-tolerated oral medication can prevent afib, it could open doors for treating existing afib.

Dr. Brundel discussed the GENIALITY Trial at the 2024 Get in Rhythm. Stay in Rhythm ® Atrial Fibrillation Patient Conference. We are pleased to provide you with complimentary access to her presentation so you can learn more about this trial and her other Patient-Focused Afib Research.

Update from Dr. Brundel as of November 27, 2024

There has been additional progress since the patient conference, so Dr. Brundel provided us with this update.

In early October of 2024, the GENIALITY Trial reached an important milestone: it has received approval from both the European Medicines Agency and Amsterdam UMC’s Medical Research Ethical Committee to start recruiting its first patient-participants. The timeline of the whole study is expected to last 12 months after the first patient inclusion.

Led by Prof. Dr. Bianca J.J.M. Brundel and Dr. Kennedy Silva Ramos, at the Academic Medical Center of Amsterdam (Amsterdam UMC), the study investigates the use of Geranylgeranylacetone (GGA) to prevent postoperative afib. This clinical trial builds on earlier findings that Heat Shock Proteins (HSPs) protect the heart from stress-induced damage, including afib. GGA, a known inducer of HSPs, has been shown in preclinical models to offer cardioprotection and prevent afib onset.

The GENIALITY Trial aims to determine if treatment with GGA reduces the incidence of postoperative afib in patients undergoing cardiothoracic surgery. It is a phase 2, randomized, double-blind, placebo-controlled study involving 85 patients, with participants receiving GGA for five days before surgery and three days after surgery. Secondary objectives include analyzing HSP responses in blood and atrial tissue samples. The results could lead to a novel approach for managing afib.

How Can You Help?

Patients can make a difference by being involved in helping fund research to help answer questions that are important to us.

Please join us in supporting this research. It is so important and such a worthy cause for our support as a patient community. StopAfib.org is passing along 100% of the proceeds of your support (after credit card fees) to the non-profit Atrial Fibrillation Innovation Platform (AFIP) that supports Dr. Brundel’s patient-focused research.

This Giving Season, will you help support vital patient-driven afib research through a charitable contribution? You can Donate here:  

Donate to support Afib Research

Or, if you have questions to help you make a Qualified Charitable Distribution (QCD) from your retirement fund, please let us know.

Thank you for your support of this vital patient-funded research.

Here are some resources to help you learn more:

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