Patient-Funded Research: GENIALITY Study: GGA for Afib Prevention

Patient-Funded Research: GENIALITY Study: GGA for Afib Prevention

GeranylGeranylAcetone to prevent postoperative Atrial Fibrillation (GENIALITY)

December 28, 2023

  • Summary: GENIALITY GGA Atrial Fibrillation Study is Patient-Funded Research Into Preventing Afib
  • Reading time:  4–5 minutes

A favorite presenter at the Get in Rhythm. Stay in Rhythm.® Atrial Fibrillation Patient Conferences for the past three years is Professor Bianca Brundel, PhD, from the physiology department at the Amsterdam University Medical Center in The Netherlands.

Dr. Brundel is at afib’s leading edge of practical basic science research. At the conferences, she gave afib patients actionable ways to help manage their afib and provided updates on her patient-driven research. In addition, she shared information on testing how toxic triggers drive afib progression and how those findings will be used to discover effective treatments and diagnostics. She also discussed patient involvement in research, including how to get involved. She founded the nonprofit Atrial Fibrillation Innovation Platform, which promotes studies in collaboration with patients. She is also the project leader of CIRCULAR, a project funded by the Dutch government based on co-creating research with afib patients and StopAfib.org.

Based on what we have learned from her, we in the patient community stepped up to help fund some of Dr. Brundel’s research. For example, she and her colleagues recently showed that structural damage to the heart results from “derailment in cardiomyocyte proteostasis” and that this damage could be counteracted by heat shock proteins (HSPs).

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 are studying 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.

We, as patients, can be involved in research to help answer important questions. We can make a difference. This research is such a worthy cause for our support as a patient community. Won’t you join us in supporting this research?

All funds donated will go directly to support this research project. We will send 100% (after credit card fees) directly to the non-profit Atrial Fibrillation Innovation Platform (AFIP) that supports Professor 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:  

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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-initiated research.

Here are some additional resources to help you learn more:

  • GeranylGeranylAcetone to prevent postoperative Atrial Fibrillation (GENIALITY) abstract (below) from trial investigator Prof. Dr. Bianca JJM Brundel. Please help support this patient-focused research.

GeranylGeranylAcetone to prevent postoperative Atrial Fibrillation (GENIALITY)

By Prof. Dr. Bianca JJM Brundel

Thanks to donations via StopAfib.org and the AFIP foundation, we are able to conduct the GENIALITY trial.

Why is this trial important?

  • In 2006, we showed that cardioprotective proteins, called Heat Shock Proteins, protect the heart against stress-induced damage, including atrial fibrillation
  • The drug Geranylgeranylacetone (GGA) boosts the levels of HSP in the heart &
  • GGA protects against experimental atrial fibrillation
  • Clinical trials showed that oral intake of GGA for 3 days increases HSP levels in the atria
  • Next step: test whether pre-treatment with GGA protects the heart against postoperative atrial fibrillation

This trial is initiated by Prof. Dr. Bianca Brundel Amsterdam UMC. It will be conducted by Dr. Kennedy Silva Ramos and the Clinical Research Unit Amsterdam UMC’s Dr. Nimrat Grewal.


Rationale

Atrial fibrillation (AF) is the most common cardiac arrhythmia in the Western world, and is highly associated with the development of stroke, heart failure, and increased mortality. Unfortunately, AF therapy is still suboptimal. In our previous study, we showed that Heat Shock Proteins (HSP) prevent atrial tissue damage due to stress, such as AF. Moreover, the HSP-inducing drug GeranylGeranylAcetone (GGA) protects the heart against AF onset and progression in clinically relevant experimental model systems.

In humans, three days of oral administration of GGA increases the HSP levels in atrial tissue of patients. Therefore, we hypothesize that oral administration of GGA comprises cardioprotective effects and protects against postoperative atrial fibrillation in patients undergoing cardiothoracic surgery.

Objective

Primary objective: Evaluate whether GGA reduces the incidence of postoperative AF after cardiothoracic surgery

Secondary objective: To investigate HSP response after treatment in blood and atrial tissue samples.

Trial design

The present study is a phase 2 single-center, double-blind, placebo-controlled randomized trial comparing the efficacy of GGA in preventing postoperative AF in 100 patients. Trial duration is 14 days.

Trial population

Participants are adult patients without any documented history of AF, undergoing open-heart surgery for underlying coronary artery bypass surgery with or without mitral valve repair, at the Cardiothoracic surgery department, Amsterdam UMC.

 

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