Overview

Clinical Research Overview

At Georgia Arrhythmia Consultants and Research Institute, we are dedicated to providing quality health care and service our patients. In addition to standard healthcare, we offer a unique opportunity for qualifying patients to participate in clinical research trials.

Clinical research trials offer patients the ability to help improve the future of medicine for all, in addition to benefiting their own health. Spearheaded by the efforts of Dr. Sogade, we have proudly participated in clinical research trials since 1997, and we look forward to contributing further knowledge to the scientific community in the future.

Our research team is currently recruiting patients for several clinical research studies. Your provider may discuss the opportunity to participate in one of these studies with you if he/she thinks you are a potential candidate. You may also be contacted by our clinical research team to assess your interest in participating in a study if you have been identified as a potential candidate. If you have not been contacted but would like to discuss a study in more detail, please contact us at 478-703-0402.

Team

Clinical Research Team

Dr. Felix Sogade (Primary Investigator) 1997-Present

Dr. Joseph Poku (Sub-Investigator) 2006-Present

Dr. Daniel Haithcock (Sub-Investigator) 2009-Present

Simisola Oludare (Clinical Research Coordinator) 2020-Present
“I am a strong advocate for research because through it, we are able to move the standard of care forward thereby improving the health of many patients.”

Andrea Law (Clinical Research Coordinator) 2020-Present
“One of the best ways to advocate for positive change in the healthcare field is to participate in clinical research which allows us improve healthcare outcomes worldwide”

Studies I

Current Studies

You may qualify for one of our studies if you have been diagnosed with the following:

-SVT (supraventricular tachycardia)

-Heart failure with reduced ejection fraction (HFrEF)

-Congestive heart failure

-Iron deficiency

-Diabetic patients with history of heart attack

-High potassium levels and congestive heart failure

-Recently hospitalized patients with heart failure and preserved ejection fraction (HFpEF)

-Atherosclerotic cardiovascular disease (ASCVD)

-ATTR amyloidosis

Studies II

Past Studies

CABANA (Catheter Ablation vs Antiarrhythmic Drug Therapy in Atrial Fibrillation)
The purpose of this trial was to determine whether catheter ablation was superior to drug therapy for treating Atrial Fibrillation. The study included over 2000 participants that were monitored over five years. The results revealed that there was no difference between receiving an ablation or drug therapy. This trial was sponsored by the NIH, St Jude Medical Foundation and Corporation, JnJ Inc., Medtronic Corporation, and Boston Scientific Corporation.

CELESTIAL (Cabozantinib (XL184) vs Placebo in Subjects with Hepatocellular Carcinoma Who Have Received Prior Sorafenib)
This purpose of this study was to evaluate the effect of Cabozantinib (XL184) versus placebo on the overall survival of subjects with advanced hepatocellular carcinoma who have previously received sorafenib. The study was a randomized, double-blind, phase 3 clinical trial that included over 700 participants. Although the study has closed to enrollment, the preliminary results are still being analyzed. As we get more results, we will update the information. This study was sponsored by Exelixis.

DISCOVERY (A Study Examining the Prevalence of TTR mutations in Subjects Suspected of Having Cardiac Amyloidosis)
This study was conducted to characterize the frequency of transthyretin (TTR) mutations in participants suspected of having cardiac amyloidosis. It was a prospective, multi-center observational study that included 1010 participants. This study was sponsored by Alnylam and has since been followed by an intervention trial aimed at curing hereditary Abnormal transthyretin mutations.

EMPERIAL preserved (The effect of 12 weeks treatment of once daily EMPagliflozin 10 mg compared with placebo on ExeRcise ability and heart failure symptoms, In patients with chronic HeArt FaiLure with preserved Ejection fraction)
This study was done to investigate the safety and efficacy of empagliflozin compared to placebo on exercise ability and heart failure symptoms in participants with heart failure and preserved ejection fraction. The study was a double blind, randomized clinical trial that involved over 300 participants evenly distributed between treatment group and placebo group. Overall, the study revealed that compared to placebo in this cohort, the study drug did not show any improvement in exercise ability as measured by the six-minute walk test and in heart failure symptoms.

EMPERIAL reduced (The effect of 12 weeks treatment of once daily EMPagliflozin 10 mg compared with placebo on ExeRcise ability and heart failure symptoms, In patients with chronic HeArt FaiLure with reduced Ejection fraction)
This study was done to investigate the safety and efficacy of empagliflozin compared to placebo on exercise ability and heart failure symptoms in participants with heart failure and reduced ejection fraction. The study was a double blind, randomized clinical trial that involved over 300 participants evenly distributed between treatment group and placebo group. Overall, the study revealed that compared to placebo in this cohort, the study drug did not show any improvement in exercise ability as measured by the six-minute walk test and in heart failure symptoms.

EVALUATE (A 12-week comparison of combined angiotensin-neprilysin inhibition with sacubitril/valsartan versus enalapril on changes in aortic stiffness in patients with heart failure and reduced ejection fraction)
Through this study, we were able to investigate whether sacubitril/valsartan could decrease aortic stiffness compared to placebo in people with heart failure and reduced ejection fraction. The study was a multi-center, randomized, double-blind, double dummy study that included over 400 participants. Overall, the study revealed no reduction in aortic stiffness for both groups and more importantly, no new safety concerns emerged as a result of the study.

Longitudinal Surveillance Study of the 4-SITE Lead/Header System
This study was designed to evaluate the clinical performance, effectiveness, and reliability of the 4-SITE Header System. The study was an observational, non-randomized, multi-center, global clinical investigation of individuals implanted with the 4-SITE Header System. The study was carried out from April 2013 to February 2020 and enrolled 1820 participants. No results have been posted as of January 2021.

Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF II)
This trial was designed to evaluate the safety of target-specific anti-coagulant medications in patients with Atrial Fibrillation. This study was conducted from February 2013 until it’s completion in July 2017, with 13769 participants enrolled. The study was a multicenter, prospective outpatient disease registry using an observational method. No results have been posted as of January 2021.

Comparison of Sacubitril/Valsartan Versus Enalapril on Effect on NT-proBNP in Patients Stabilized From an Acute Heart Failure Episode (PIONEER-HF)
This trial was designed to evaluate the effectiveness of in-hospital inhalation sacubitril/valsartan vs. enalapril related to change in NT-proBNP in stable patients following hospitalization for acute decompensated heart failure (ADHF) and reduced ejection fraction. This study was a multicenter, randomized, double-blind, parallel group, active-controlled trial which enrolled 887 participants. The study was active from April 2016 to July 2018. The trial revealed that sacubitril/valsartan reduced NT-proBNP to a greater extent when compared with enalapril.

Ranolazine Implantable Cardioverter-Defibrillator Trial (RAID)
This study was designed to evaluate the effectiveness of a drug named ranolazine in reducing the instance of ventricular arrhythmias and death in patients with implantable cardioverter-defibrillators (ICDs). The study was a randomized double-blind, placebo-controlled clinical trial. The study was active from September 2011 until its completion in February 2017 with 1440 patients enrolled. The study revealed that ranolazine did not significantly reduce the incidence of ventricular arrhythmias or death in high-risk ICD patients. However, it did reveal that there was a significant reduction in recurrent ventricular arrhythmias in ICD patients who were not high-risk.

Reveal LINQ™ In-Office 2 (RIO 2) Study United States
This clinical trial was designed to demonstrate that the Reveal LINQ™ inserted in an office setting is as safe as the LINQ™ inserted in a traditional hospital setting. The study was conducted from March 2015 to May 2016 with 525 participants enrolled. The study revealed that the LINQ™ was equally as safe to be inserted in an office setting as well as a hospital setting.

OMNI Study--Assessing Therapies in Medtronic Pacemaker, Defibrillator, and Cardiac Resynchronization Therapy Devices
This study was designed to assess the effectiveness of therapies used by Medtronic pacemakers, defibrillators, and cardiac resynchronization therapy devices to treat and prevent life threatening arrhythmias. The study was carried out from August 2005 to November 2010 and enrolled 3032 participants.

Testing

Genetic Testing

At GACRI, we have partnered with a genetic testing company called Invitae© to screen for a genetic or inherited component to sudden cardiac arrest, cardiomyopathy or neuropathy.

Our clinical research team is currently conducting a trial involving a genetic mutation called hereditary Abnormal Transthyretin (hATTR) amyloidosis. Transthyretin amyloidosis is a mutation which causes an abundance of the protein transthyretin to build up in the body, specifically the heart, causing a range of symptoms associated with heart disease. Patients who receive genetic testing and a positive result for hATTR amyloidosis may qualify for this clinical trial, which uses a new medication designed to treat the symptoms related to this mutation. If you have symptoms of neuropathy or cardiomyopathy, your provider may discuss genetic testing as a part of a comprehensive evaluation in order to provide you with the highest level of care. For more information related to hATTR amyloidosis, visit www.hATTbridge.com.

Through genetic testing we may also be able to determine whether your arrhythmias and other cardiac syndromes (such as Brugada, Arrhythmogenic Right Ventricular Dysplasia and Long QT syndrome) are genetically linked in order to allow you and your family the opportunity to receive genetic counseling and other treatment opportunities beyond the standard of care.

If a genetic test is ordered for you or your family member, the process is as follows:

-Our provider will discuss testing with you.

-A biological specimen such as blood or saliva will be collected from the patient.

-The sample is sent to the genetic testing company, Invitae© for processing and analyzing. This process takes between 10 and 21 business days.

-Once results are processed, a report is generated through an online portal which the clinical research staff will access and provide to the ordering physician to review.

-After the physician has signed off on the results and directed the research staff how to proceed, the clinical research team will reach out to the patient with the test results and a plan of care.

-If you receive unsolicited genetic testing requests from our practice, please check with our office prior to participating

If you would like more information regarding genetic testing, please contact our clinical research team at 478-703-0402.

Contact

Contact Us

Phone: 478-703-0402

Fax: 478-755-1562

Email: research@gacri.com