Amiodarone Patches for Atrial Fibrillation
(AMIOMEND Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: Helios Cardio Inc.
Must not be taking: Corticosteroids, Anti-inflammatories, QT prolongers, others
Disqualifiers: Pregnancy, Connective tissue diseases, others
No Placebo Group
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?The goal of this clinical trial is to is to test the safety of a new way to deliver a commonly used drug (amiodarone) used in heart surgery by placing a patch containing the drug directly on the heart instead of in an IV (vein). Participating subjects must be 20-85 year old males or females. Up to 80 participants having cardiac surgery at the University of Louisville will be involved in this study.
The main questions this study aims to answer are:
1. Is the patch safe?
2. Does the patch lower the rate of atrial fibrillation (irregular heart rhythm) after cardiac surgery?
Researchers will compare up to 3 different doses of the amiodarone patches (low, medium and high) to the usual treatment (Standard of Care) to see if there are differences (increases or decreases) in heart rhythms after cardiac surgery across study groups.
Participants will be placed in one of 4 study groups:
* Standard of Care (20 participants)
* Low dose patch (20 participants)
* Medium dose patch (20 participants)
* High dose patch (20 participants)
Participants will be monitored closely by their doctor(s) during the study and would:
* Agree to participate after having their doctor, or a member of the team, explain the study in detail and allowing them to ask any questions they would like.
* Sign an Informed Consent Form which will describe the study and tests in full.
* Agree to have their doctor and his/her research team record your medical information, draw blood, and perform electrocardiograms, or EKGs (quick, painless test that measures the electrical activity of the heart) and echocardiograms (image of heart) to monitor their heart.
* Agree to receive training on the portable EKG recorder and to use it at home approximately 30 days and 6 months after their surgery to monitor their heart.
* Agree to return to the hospital approximately 30 days and 6 months after their surgery for a study visit.
Participant involvement will be approximately 7 months total.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications that interact with amiodarone, such as doxorubicin, fosphenytoin, and others listed in the exclusion criteria. If you are on these medications, you may need to stop them to participate in the trial.
What data supports the effectiveness of the Amiodarone-Infused CardiaMend Patches for treating atrial fibrillation?
Research suggests that delivering amiodarone directly to the heart through a patch can reduce the risk of atrial fibrillation while minimizing side effects, as it targets the heart specifically and avoids high drug levels in the rest of the body.
12345Is Amiodarone safe for use in humans?
Amiodarone has been used successfully for many years to treat heart rhythm problems, but it can have serious side effects, especially with long-term use. A newer version, Nexterone, may have fewer side effects like low blood pressure. However, it's important to monitor for potential adverse effects when using amiodarone.
678910How is the Amiodarone-Infused CardiaMend Patch treatment for atrial fibrillation different from other treatments?
The Amiodarone-Infused CardiaMend Patch is unique because it delivers the drug directly to the heart tissue, potentially reducing side effects that occur with oral or intravenous administration, which affects the whole body.
111121314Eligibility Criteria
This trial is for men and women aged 20-85 undergoing cardiac surgery at the University of Louisville. They must be willing to consent to medical monitoring, blood draws, EKGs, echocardiograms, use a portable EKG recorder post-surgery, and return for follow-up visits.Inclusion Criteria
Subjects in sinus rhythm at the time of office visit and during prior EKG (continuous EKG monitoring for 48 hours is not required)
I am between 20 and 85 years old.
Subjects able to give voluntary written informed consent, understand, and comply with study-related procedures
+1 more
Exclusion Criteria
I have an active infection where my implant will be placed.
I have had heart surgery through a cut in my chest bone.
I am not pregnant, breastfeeding, have been pregnant in the last 3 months, or planning to become pregnant during the study.
+16 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo cardiac surgery and receive amiodarone-infused CardiaMend patches or standard care
Up to 2 months or until hospital discharge
In-hospital monitoring
Follow-up
Participants are monitored for safety and effectiveness after treatment, including use of portable EKG recorder at home
6 months
2 visits (in-person) at 30 days and 6 months post-surgery
Extension
Participants may continue to be monitored for long-term outcomes and safety
Long-term
Participant Groups
The study tests Amiodarone-Infused CardiaMend patches (70mg, 150mg & 300mg) against standard care in preventing new-onset atrial fibrillation after heart surgery. Participants are randomly assigned to one of four groups: standard care or low, medium or high dose patch.
4Treatment groups
Experimental Treatment
Active Control
Group I: Group 4: 20 subjects receiving CardiaMend-Amiodarone infused with 300 mg of amiodarone.Experimental Treatment1 Intervention
Subjects in Group 4 (300 mg) will receive three patches each as follows:
* One patch (5x6 cm) will be placed on top of the right atrium;
* One patch (3x5 cm) will be placed within the transverse sinus near the dome of the left atrium; and
* One patch (3x5 cm) will be placed within the oblique sinus on the posterior/inferior aspect of left atrium
Group II: Group 3: 20 subjects receiving CardiaMend-Amiodarone infused with 150 mg of amiodarone.Experimental Treatment1 Intervention
Subjects in Group 3 (150 mg) will receive three patches each as follows:
* One patch (5x6 cm) will be placed on top of the right atrium;
* One patch (3x5 cm) will be placed within the transverse sinus near the dome of the left atrium; and
* One patch (3x5 cm) will be placed within the oblique sinus on the posterior/inferior aspect of left atrium
Group III: Group 2: 20 subjects receiving CardiaMend-Amiodarone infused with 70 mg of amiodaroneExperimental Treatment1 Intervention
Subjects in Group 2 (70 mg) will receive three patches each as follows:
* One patch (5x6 cm) will be placed on top of the right atrium;
* One patch (3x5 cm) will be placed within the transverse sinus near the dome of the left atrium; and
* One patch (3x5 cm) will be placed within the oblique sinus on the posterior/inferior aspect of left atrium
Group IV: Group 1: 20 subjects in the control group, which is the standard of care (i.e., no CardiaMend-AmiodaActive Control1 Intervention
Subjects in treatment Group 1 (control) will receive no CardiaMend-Amiodarone patches.
Amiodarone-Infused CardiaMend Patches is already approved in United States, European Union, Canada, Japan for the following indications:
🇺🇸 Approved in United States as Cordarone for:
- Ventricular arrhythmias
- Atrial fibrillation
🇪🇺 Approved in European Union as Cordarone for:
- Ventricular arrhythmias
- Atrial fibrillation
- Tachyarrhythmias
🇨🇦 Approved in Canada as Nexterone for:
- Ventricular arrhythmias
- Atrial fibrillation
🇯🇵 Approved in Japan as Pacerone for:
- Ventricular arrhythmias
- Atrial fibrillation
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of LouisvilleLouisville, KY
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Who Is Running the Clinical Trial?
Helios Cardio Inc.Lead Sponsor
References
Atrium-targeted drug delivery through an amiodarone-eluting bilayered patch. [2018]Clinical studies have demonstrated the efficacy of oral and intravenous amiodarone therapy to prevent postoperative atrial fibrillation. However, because of significant extracardiac side effects, only high-risk patients are eligible for prophylactic amiodarone therapy. This study addressed the hypothesis that atrium-specific drug delivery through an amiodarone-eluting epicardial patch reduces vulnerability to atrial tachyarrhythmias, whereas ventricular and plasma drug concentrations are minimized.
New anthyarrhythmic drugs for atrial fibrillation. [2018]Atrial fibrillation (AF) is a common arrhythmia associated with increased mortality and morbidity. Different studies have shown no significant difference between rhythm and rate control strategies in terms of mortality. Moreover, the use of antiarrhythmic drugs is afflicted by cardiac and extracardiac toxicity and related costs of hospitalization. Nevertheless, some patients require a rhythm-control strategy and new anti-AF agents are being sought. Only few novel agents showed promising results in term of efficacy and safety. Dronedarone and vernakalant are two of these compounds, respectively introduced for the chronic and acute rhythm control of AF. This article will review pharmacology and clinical evidence on the use of dronedarone and vernakalant and will mention currently investigated new antiarrhythmic drugs.
Benefit-risk assessment of dronedarone in the treatment of atrial fibrillation. [2021]Rhythm control in atrial fibrillation (AF) can be achieved using pharmacological therapy. Amiodarone is the most efficacious anti-arrhythmic agent; however, its use is limited due to an unfavourable safety profile, including pro-arrhythmia, thyroid, liver, skin and pulmonary complications. Dronedarone, which is structurally similar to amiodarone, was developed to try and achieve a favourable balance of efficacy and risk. Dronedarone has been evaluated in several large clinical trials, which have shown reduced mortality and hospitalization rates in patients with non-permanent AF. In patients with permanent AF and/or heart failure, dronedarone has been shown to cause increased mortality and morbidity and should not be used in these groups. Compared with amiodarone, dronedarone has fewer toxic effects (thyroid, skin, pulmonary) and, although less efficacious, may be used as first-line therapy for maintenance of sinus rhythm in patients with non-permanent AF. Clinicians must be vigilant in monitoring their patients to ensure they do not develop permanent AF or heart failure.
Cardiac rate normalization in chronic atrial fibrillation: comparison of long-term efficacy of treatment with amiodarone versus AV node ablation and permanent His-bundle pacing. [2013]Chronic atrial fibrillation (AF) is a common arrhythmia with significant morbidity and mortality. AF has been the subject of considerable attention and intensive clinical research in recent years. Current opinion on the management of AF favors the restoration and maintenance of normal ventricular rhythm. This has several potential benefits, including the alleviation of arrhythmia-associated symptoms and hemodynamic improvements. Maintenance of frequents normalization of ventricular rhythm (NVR) can be achieved with antiarrhythmic drug therapy or with AV node radiofrequency ablation (RFA) and permanent ventricular pacing. Recent interest has focused on the use of class III antiarrhythmic agents, such as amiodarone hydrochloride. This investigation compared amiodarone to AV node RFA and permanent pacing of the His-bundle area in maintaining NVR in patients with resistant chronic AF. After 12 months of treatment with amiodarone (200 to 400 mg/d) 30 % of patients remained in NVR, 30 % were in transitional phase of improvement, and 40 % showed negative effect. Only a few patients in this group developed ocular or hepatic side effects. On one year follow-up was achieved in 100 % of cases without any clinically significant side effects being seen. In conclusion, analysis of the results of this study suggests that low-dose amiodarone is well tolerated in the management of chronic AF in a selected patient population. The more aggressive interventional radiofrequency ablation technique is significantly more effective and more reliable in the long-term clinical treatment of drug-resistant AF.
Emerging pharmacotherapies for the treatment of atrial fibrillation. [2018]The main aim of current research on the field of atrial fibrillation (AF) treatment is to find new antiarrhythmic drugs with less side effects. Areas covered: Dronedarone and vernakalant showed promising result in term of efficacy and safety in selected patients. Ranolazine and colchicine are obtaining a role as a potential antiarrhythmic drug. Ivabradine is used in experimental studies for the rate control of AF. Moreover, new compounds (vanoxerine, moxonidine, budiodarone) are still under investigation. Monoclonal antibodies or selective antagonist of potassium channel are under investigation for long term maintenance of sinus rhythm. Clinical evidence and new pharmacological investigation on new drugs will be accurately reviewed in this article. Expert opinion: Dronedarone use is not recommended in patients with symptomatic heart failure (HF), NYHA class III-IV, depressed ventricular function and permanent AF, especially in patients assuming a concomitant therapy with digoxin. Vernakalant had superior efficacy than amiodarone, flecainide and propafenone in single studies and similar efficacy to direct current cardioversion. Several of the developing drugs examined in this paper show an interesting potential, in particular the research on selective ionic channel inhibition and on compounds which reduce the inflammation state, especially after ablation or surgery.
Amiodarone (Nexterone) injection for the treatment and prophylaxis of frequently recurring ventricular fibrillation. [2013]Intravenous (IV) amiodarone is the most used and effective drug to manage life-threatening ventricular arrhythmias. However, its administration is associated with important adverse effects, the most frequent of which is hypotension. Nexterone® is a novel IV amiodarone formulation, proved to be devoid of hypotensive effects in clinical studies and may represent an improved and safer instrument in this setting.
Efficacy and safety of dronedarone in the treatment of patients with atrial fibrillation. [2018]Dronedarone, a derivative of amiodarone with structural modifications, was designed to have similar electrophysiological properties with a less toxic profile. Areas covered: Brief overview of the pharmacology of dronedarone followed by a summary of randomized clinical trials testing the efficacy of dronedarone in maintaining normal sinus rhythm and clinical outcomes associated with these trials. In depth discussion and commentary on trial findings which may seem contradictory at first approach and brief discussion of post-marketing surveillance studies. Expert opinion: Dronedarone is a moderately efficacious anti-arrhythmic agent which is safe for use in a carefully selected patient population, maintained in normal sinus rhythm, without advanced congestive heart failure, structural heart disease, permanent atrial fibrillation, digoxin use. It is especially useful in younger patients who lack other risk factors for cardiovascular events and, who stand to gain the most by avoiding long-term pulmonary and thyroid toxicities associated with more effective, but also significantly more toxic agents such as amiodarone.
Amiodarone--an investigative drug in the coronary care unit. [2013]Amiodarone is an investigative antiarrhythmic drug in the United States. However, it has been used successfully in European countries for the past 14 years. Amiodarone is effective in the long-term management of resistant supraventricular and ventricular arrhythmias. Although a very useful addition to the antiarrhythmic drugs currently in use, it has potential side effects that have delayed its acceptance by the Food and Drug Administration. The consensus of opinion among the clinical investigators of amiodarone is that it will be released for limited clinical use in the near future. Cardiovascular nurses involved in the design, coordination, and conduction of clinical investigations need to be vigilant in objectively monitoring and documenting both the potential efficacy and possible adverse effects of all interventions in research subjects.
Dronedarone: a new antiarrhythmic agent. [2018]Dronedarone (SR 33589; N,N-dibutyl-3-[4-([2-butyl-5-methylsulphonamido] benzofuran-3-yl-carbonyl) phenoxy]propylamine) is a new synthetic noniodinated derivative of amiodarone that is currently undergoing phase III clinical trials. It demonstrates electrophysiologic patterns similar to amiodarone and shows equivalent efficacy in preventing or converting various ventricular and atrial arrhythmias in laboratory animals. Two phase III trials demonstrated that dronedarone is safe and effective for the maintenance of normal sinus rhythm in patients with atrial fibrillation or atrial flutter. Dronedarone at the dose of 400 mg twice daily was effective in preventing both symptomatic and asymptomatic recurrences of atrial fibrillation or atrial flutter and had a safety profile similar to that of placebo. Further studies are needed to determine the long-term effectiveness and safety of dronedarone in various groups of patients with atrial fibrillation. Other clinical applications of this novel antiarrhythmic drug need to be determined in future clinical trials.
A review of the investigational antiarrhythmic agent dronedarone. [2018]Arrhythmias are a major cause of morbidity and mortality, and atrial fibrillation is the most widespread disorder of cardiac rhythm. Amiodarone is an effective antiarrhythmic agent that has been in clinical use for about 20 years. It is effective for multiple types of arrhythmias, including atrial fibrillation, and has a low incidence of cardiac adverse events, including Torsade de Pointes. It has many noncardiac adverse effects that are serious and limit its long-term use. Dronedarone is an investigational antiarrhythmic agent that is designed to have similar cardiac effects to amiodarone but with fewer adverse effects. This review presents some of the animal and human studies that evaluate the effects of dronedarone.
Dronedarone. [2022]Amiodarone is the most effective antiarrhythmic drug for maintaining sinus rhythm for patients with atrial fibrillation. Extra-cardiac side effects have been a limiting factor, especially during chronic use, and may offset its benefits. Dronedarone is a noniodinated benzofuran derivative of amiodarone that has been developed for the treatment of atrial fibrillation and atrial flutter. Similar to amiodarone, dronedarone is a potent blocker of multiple ion currents, including the rapidly activating delayed-rectifier potassium current, the slowly activating delayed-rectifier potassium current, the inward rectifier potassium current, the acetylcholine activated potassium current, peak sodium current, and L-type calcium current, and exhibits antiadrenergic effects. It has been studied for maintenance of sinus rhythm and control of ventricular response during episodes of atrial fibrillation. Dronedarone reduces mortality and morbidity in patients with high-risk atrial fibrillation, but may be unsafe in those with severe heart failure. This article will review evidence of safety and effectiveness of dronedarone in patients with atrial fibrillation.
Role of amiodarone in the era of the implantable cardioverter defibrillator. [2019]Amiodarone is one of the most frequently used antiarrhythmic drugs in clinical practice. In patients with atrial fibrillation, in whom rhythm control is judged desirable, amiodarone is the most effective therapy. Amiodarone effectively prevents atrial fibrillation and may improve quality of life, but there is no evidence that it decreases mortality or severe morbidity in atrial fibrillation. In patients at risk for life-threatening ventricular arrhythmias, amiodarone may decrease mortality to a small degree, but the evidence for this benefit is incomplete. Patients with implantable cardioverter defibrillators frequently require antiarrhythmic drug therapy, especially to treat electrical storm. Amiodarone is useful in these patients; however, it may increase defibrillation thresholds in some patients. In patients with out-of-hospital DC shock-resistant VF, amiodarone is the most effective antiarrhythmic drug available to assist in resuscitation. Amiodarone is a complicated drug, and its optimal use requires careful patient surveillance with respect to potential adverse effects.
Topical amiodarone during cardiac surgery: Does epicardial application of amiodarone prevent postoperative atrial fibrillation? [2019]Atrial fibrillation (AF) is a common complication after cardiac surgery. Topical amiodarone on the epicardium may help prevent postoperative AF while avoiding the side effects of its systemic administration. The purpose of this study was to evaluate the all-comer strategy of epicardial amiodarone application for the prevention of postoperative AF.
Amiodarone: clinical trials. [2022]Amiodarone is an antiarrhythmic agent commonly used in the treatment of supraventricular and ventricular tachyarrhythmias. This article reviews the results and clinical implications of primary and secondary prevention trials in which amiodarone was used in one of the treatment arms. Key post-myocardial infarction primary prevention trials include the European Myocardial Infarct Amiodarone Trial (EMIAT) and the Canadian Amiodarone Myocardial Infarction Trial (CAMIAT), both of which demonstrated that amiodarone reduced arrhythmic but not overall mortality. In congestive heart failure patients, amiodarone was studied as a primary prevention strategy in two pivotal trials: Grupo de Estudio de la Sobrevida en la Insuficiencia Cardiac en Argentina (GESICA) and Amiodarone in Patients With Congestive Heart Failure and Asymptomatic Ventricular Arrhythmia (CHF-STAT). Amiodarone was associated with a neutral overall survival and a trend toward improved survival in nonischemic cardiomyopathy patients in CHF/STAT and improved survival in GESICA. In post-myocardial infarction patients with nonsustained ventricular tachycardia and a depressed ejection fraction, the Multicenter Automatic Defibrillator Implantation Trial (MADIT) demonstrated that implantable cardioverter-defibrillators (ICD) statistically improved survival compared to the antiarrhythmic drug arm, most of whose patients were taking amiodarone. In patients with histories of sustained ventricular tachycardia or ventricular fibrillation, the Cardiac Arrest Study in Seattle: Conventional Versus Amiodarone Drug Evaluation (CASCADE) trial demonstrated that empiric amiodarone lowered arrhythmic recurrence rates compared to other drugs guided by serial Holter or electrophysiologic studies. However, arrhythmic death rates were high in both treatment arms of the study. Several secondary prevention trials, including the Antiarrhythmics Versus Implantable Defibrillators Study (AVID), the Canadian Implantable Defibrillator Study (CIDS), and the Cardiac Arrest Study Hamburg (CASH), have demonstrated the superiority of ICD therapy compared to empiric amiodarone in improving overall survival. Based on the above findings, amiodarone is safe to use in post-myocardial infarction and congestive heart failure patients that need antiarrhythmic therapy. Although amiodarone is effective in treating malignant arrhythmias, high-risk patients should be considered for an ICD as frontline therapy.