Clinical Trials

Amiodarone hydrochloride has been evaluated across numerous clinical trials spanning Phase 1 to Phase 4, primarily addressing cardiac arrhythmias—including atrial fibrillation, supraventricular tachycardia, and atrial flutter—alongside coronary artery disease and esophageal carcinoma. Sponsored by pharmaceutical leaders like Sanofi as well as academic institutions such as Massachusetts General Hospital and the OHSU Knight Cancer Institute, these studies range in status from completed to actively recruiting. Overall, this research assesses its prophylactic and therapeutic utility to optimize post-surgical heart rhythm management and improve perioperative outcomes.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03868150 RECRUITING
Postoperative Atrial Fibrillation
Stanford University
2017-03-01 PHASE4
NCT05841056 RECRUITING
Atrial Fibrillation New Onset
Population Health Research Institute
2024-06-13 PHASE3
NCT06322017 RECRUITING
Atrial Fibrillation
Nantes University Hospital
2024-04-09
NCT07519161 NOT_YET_RECRUITING
Atrial Fibrillation
Shanghai East Hospital
2026-04-07
NCT07405671 NOT_YET_RECRUITING
Atrial Fibrillation (AF); Coronary Artery Disease
Universitaire Ziekenhuizen KU Leuven
2026-09 PHASE4
NCT04748991 NOT_YET_RECRUITING
Atrial Fibrillation; Post-cardiac Surgery
University of Calgary
2026-09 PHASE3
NCT05543278 NOT_YET_RECRUITING
Surgery, Cardiac; Atrial Fibrillation
Massachusetts General Hospital
2027-01 PHASE4
NCT06680869 RECRUITING
Cardiac Arrest
Oregon Health and Science University
2025-01-01 PHASE3
NCT06669299 RECRUITING
Ventricular Tachycardia (VT)
IRCCS Ospedale San Raffaele
2025-06-12
NCT07273994 RECRUITING
Persistent Atrial Fibrillation
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
2025-11-01 PHASE4
NCT06067438 RECRUITING
Atrial Fibrillation; Esophageal Carcinoma
OHSU Knight Cancer Institute
2024-06-21 PHASE2
NCT06063538 RECRUITING
Atrial Fibrillation; Post-Op Complication
University of Chicago
2024-02-15 EARLY_PHASE1
NCT07487714 ENROLLING_BY_INVITATION
Paroxysmal AF; Treatment Decisions; Therapeutic Drug Monitoring (TDM)
Tomsk National Research Medical Center of the Russian Academy of Sciences
2026-01-12 PHASE4
NCT02750319 ACTIVE_NOT_RECRUITING
Thoracic Surgery; Atrial Fibrillation in High Risk Patients
Memorial Sloan Kettering Cancer Center
2016-04 PHASE3
NCT01422148 NOT_YET_RECRUITING
Atrial Fibrillation
Baystate Medical Center
2025-07 PHASE2
NCT06722196 RECRUITING
Atrial Fibrillation (AF)
Jilin Heart Hospital
2025-02-15 PHASE3
NCT06835491 RECRUITING
Ventricular Arrhythmias and Cardiac Arrest
Versailles Hospital
2025-11-06 PHASE3
NCT06645249 NOT_YET_RECRUITING
Atrial Fibrillation (AF)
Institut Investigacio Sanitaria Pere Virgili
2024-12-10 PHASE4
NCT06742866 NOT_YET_RECRUITING
Atrial Fibrillation (AF)
Shanghai Chest Hospital
2024-12-16
NCT07181265 NOT_YET_RECRUITING
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Jemincare
2025-10-30 PHASE1
NCT04594746 TERMINATED
Atrial Fibrillation
University of Calgary
2022-02-03 PHASE4
NCT05549752 RECRUITING
Atrial Fibrillation Paroxysmal; Coronary Artery Disease Without Residual Ischemia
Hippocration General Hospital
2023-03-24 PHASE3
NCT06730828 RECRUITING
Atrial Fibrillation, Postoperative
Helios Cardio Inc.
2024-12-16 PHASE1; PHASE2
NCT05287191 UNKNOWN
Atrial Fibrillation New Onset
Sunnybrook Health Sciences Centre
2022-01-05 PHASE3
NCT04942834 COMPLETED
Atrial Fibrillation, Persistent; Arrhythmias, Cardiac
Ruijin Hospital
2021-10-01
NCT05169866 UNKNOWN
New Onset Atrial Fibrillation; Complications; Cardiac, Postoperative
Beijing Anzhen Hospital
2022-05-29 PHASE3
NCT06657404 RECRUITING
Atrial Fibrillation (AF)
Yumei Xue
2024-10-23
NCT06262932 COMPLETED
Atrial Fibrillation
Police General Hospital, Thailand
2024-05-01 PHASE4
NCT06067438 Not yet recruiting
Atrial Fibrillation|Esophageal Carcinoma
OHSU Knight Cancer Institute
2024-05-01 Phase 2
NCT05841056 Not yet recruiting
Atrial Fibrillation New Onset
Population Health Research Institute
2024-05-31 Phase 3
NCT05852704 Recruiting
Chronic Coronary Syndrome|Atrial Fibrillation
Region Örebro County|Odense University Hospital|Aarhus University Hospital|Örebro University Sweden|Sahlgrenska University Hospital Sweden|Göteborg University|University of Leeds|Skane University Hospital|London School of Hygiene and Tropical Medicine|St. Anne''s University Hospital Brno Czech Republic|Mount Sinai Hospital New York|University Hospital Linkoeping|Icahn School of Medicine at Mount Sinai
2024-04-04 Phase 3
NCT04392921 UNKNOWN
Atrial Fibrillation
Ottawa Hospital Research Institute
2022-03-07
NCT05681182 COMPLETED
Post Operative Atrial Fibrillation
WakeMed Health and Hospitals
2023-01-20 PHASE4
NCT05543278 Not yet recruiting
Surgery Cardiac|Atrial Fibrillation
Massachusetts General Hospital
2024-02-01 Phase 4
NCT05445297 COMPLETED
Atrial Fibrillation Paroxysmal
National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
2022-01-26 PHASE4
NCT05125042 UNKNOWN
Persistent Atrial Fibrillation
Shanghai Chest Hospital
2021-12-01
NCT05641883 UNKNOWN
POAF; Atrial Fibrillation
Saint Alphonsus Regional Medical Center
2023-01-01
NCT04234906 UNKNOWN
Cardiac; Dysrhythmia, Postoperative; Congenital Heart Surgery
Jeffrey Moak
2023-01 PHASE4
NCT04845607 UNKNOWN
Cardiac Arrest; Ventricular Arrythmia
Won Young Kim
2021-04-01 PHASE3
NCT05004077 TERMINATED
Atrial Fibrillation
Kevin W Hatton, MD, PhD
2021-11-02 PHASE4
NCT01722942 UNKNOWN
Chagas Cardiomyopathy; Non-sustained Ventricular Tachycardia; At Least 10 Points in Rassi Risk Score for Death
InCor Heart Institute
2014-10-06
NCT03029169 COMPLETED
Supraventricular Arrhythmia; Septic Shock
Charles University, Czech Republic
2017-10-23 PHASE4
NCT05950971 TERMINATED
Atrial Fibrillation New Onset; Atrial Fibrillation Paroxysmal
Seoul National University Hospital
2021-07-01
NCT03991754 UNKNOWN
Atrial Fibrillation New Onset
Luis Nombela Franco
2019-06-30 PHASE3
NCT03228823 UNKNOWN
Ventricular Premature Beats, Contractions, or Systoles; Cardiomyopathies
Hunter Holmes Mcguire Veteran Affairs Medical Center
2018-08-01 PHASE4
NCT04223739 UNKNOWN
Atrial Fibrillation; Cardiac Surgery
University Hospital, Caen
2019-12-13 PHASE4
NCT04351763 COMPLETED
COVID-19
Nicolaus Copernicus University
2020-05-20 PHASE2; PHASE3
NCT05058053 COMPLETED
Phlebitis
Saglik Bilimleri Universitesi
2020-03-01
NCT02924285 COMPLETED
Heart Diseases; Cardiomyopathies; Ventricular Premature Complexes
University of Leipzig
2017-11-01 PHASE3
NCT03842020 COMPLETED
Heart Rhythm Disorder
Assistance Publique - Hôpitaux de Paris
2019-02-13
NCT03720210 TERMINATED
Amiodarone-Induced Thyrotoxicosis
Mayo Clinic
2018-11-19
NCT03715556 UNKNOWN
Sepsis; Septic Shock; Atrial Fibrillation; Ventricular Fibrillation; Atrial Fibrillation Rapid
University of Sao Paulo General Hospital
2018-12-01 PHASE3
NCT04092621 UNKNOWN
New Onset Atrial Fibrillation; Sepsis; Respiratory Failure
Our Lady of the Lake Hospital
2019-09-16 PHASE4
NCT03193749 UNKNOWN
Chagas Cardiomyopathy
Fundación Cardioinfantil Instituto de Cardiología
2017-06-12 PHASE3
NCT03905759 UNKNOWN
Postoperative Atrial Fibrillation
doaa rashwan
2019-04-03 PHASE2; PHASE3
NCT03855826 UNKNOWN
Ventricular Tachycardia; Ventricular Fibrillation
Sichuan Baili Pharmaceutical Co., Ltd.
2019-01-15 PHASE4
NCT03299517 UNKNOWN
Arrhythmias Ventricular
University of Sao Paulo General Hospital
2017-08-02 PHASE4
NCT03221764 COMPLETED
Atrial Fibrillation; Lung Transplant; Complications
University of Louisville
2017-10-19 PHASE2
NCT02248753 COMPLETED
Atrial Fibrillation
Maastricht University Medical Center
2014-10
NCT02668432 TERMINATED
New Onset Atrial Fibrillation; Severe Sepsis; Septic Shock
The University of Texas Health Science Center at San Antonio
2016-05 PHASE4
NCT02294955 UNKNOWN
Atrial Fibrillation; Quality of Life
Uppsala University Hospital
2008-05
NCT02341105 TERMINATED
Atrial Fibrillation
Population Health Research Institute
2016-01 PHASE4
NCT02715687 UNKNOWN
Atrial Fibrillation
Rambam Health Care Campus
2016-03 PHASE3
NCT02145546 UNKNOWN
Atrial Fibrillation
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
2014-05 PHASE4
NCT03153072 WITHDRAWN
Supraventricular Tachycardia
Centre Hospitalier Universitaire, Amiens
2016-09-06 PHASE2
NCT03857711 UNKNOWN
Arrhythmias, Cardiac; Cardiovascular Diseases; Postoperative Atrial Fibrillation; Myocardial Ischemia
National Research Center of Surgery, Russia
2016-09-01
NCT01850277 UNKNOWN
Atrial Fibrillation; Heart Failure
National Institute of Cardiology, Warsaw, Poland
2013-10 PHASE4
NCT01511263 TERMINATED
Primary Amyloidosis of Light Chain Type
Fondazione IRCCS Policlinico San Matteo di Pavia
2012-01 PHASE2
NCT02301390 TERMINATED
Ventricular Tachycardia
Icahn School of Medicine at Mount Sinai
2009-10
NCT01627106 WITHDRAWN
Atrial Fibrillation
Advanz Pharma
2012-09 PHASE4
NCT01401647 COMPLETED
Cardiac Arrest
University of Washington
2012-05 PHASE3
NCT01276093 TERMINATED
Atrial Fibrillation
Abbott Medical Devices
2011-07
NCT02132767 COMPLETED
Postoperative Atrial Fibrillation
Icahn School of Medicine at Mount Sinai
2014-05 PHASE3
NCT01649544 TERMINATED
Mitral Valvulopathy; Atrial Fibrillation
Centre Hospitalier Universitaire de Saint Etienne
2012-03
NCT00721032 WITHDRAWN
Ventricular Tachycardia
Johns Hopkins University
2012-06
NCT02307591 WITHDRAWN
Ebola Virus Disease
Emergency NGO Onlus
2014-12 PHASE2; PHASE3
NCT01798277 WITHDRAWN
Ventricular Tachycardia; Coronary Artery Disease
Newmarket Electrophysiology Research Group Inc
2013-04 PHASE3
NCT01817439 UNKNOWN
Atrial Fibrillation
Western Galilee Hospital-Nahariya
2013-05 PHASE3
NCT01416935 TERMINATED
Atrial Fibrillation
Inova Health Care Services
2011-01-01
NCT01955759 UNKNOWN
Patients With Coronary Artery Disease Scheduled for by Pass Surgery
Heart Center BH Tuzla
2013-12 EARLY_PHASE1
NCT01341353 UNKNOWN
Atrial Fibrillation
Wuhan University
2011-04 PHASE4
NCT00729911 COMPLETED
Heart Failure
Texas Cardiac Arrhythmia Research Foundation
2008-10 PHASE4
NCT01181414 COMPLETED
Chronic Heart Failure; Cardiomyopathy, Dilated; Atrial Fibrillation
Hospital Clinic of Barcelona
2010-10 PHASE4
NCT01173809 COMPLETED
Atrial Fibrillation
Texas Cardiac Arrhythmia Research Foundation
2010-10 PHASE3
NCT01576042 TERMINATED
Ventricular Tachycardia
Duke University
2012-05
NCT00826826 COMPLETED
Atrial Fibrillation
Rigshospitalet, Denmark
2009-01
NCT01558830 UNKNOWN
Chronic Stable Angina; Coronary Artery Disease; Atrial Fibrillation; Ventricular Tachycardia
Cardiovascular Consultants of Nevada
2012-01 PHASE4
NCT01558128 TERMINATED
Cardiac Disease
Weill Medical College of Cornell University
2012-03
NCT01480336 COMPLETED
Arrhythmia
Hartford Hospital
2011-02
NCT01266681 UNKNOWN
Atrial Fibrillation
Eastbourne General Hospital
2011-03
NCT01199081 COMPLETED
Atrial Fibrillation
Sanofi
2010-10 PHASE4
NCT01097330 TERMINATED
Defibrillators, Implantable; Tachycardia, Ventricular
Population Health Research Institute
2010-08 PHASE3
NCT01709682 COMPLETED
Paroxysmal Atrial Fibrillation; Failed First Radiofrequency Ablation Procedure
Meshalkin Research Institute of Pathology of Circulation
2007-11 PHASE2
NCT00953212 COMPLETED
Atrial Fibrillation; Atrial Flutter
MaineHealth
2009-08 PHASE3
NCT01140581 COMPLETED
Atrial Fibrillation
Sanofi
2010-09 PHASE4
NCT00383799 TERMINATED
Ventricular Tachycardia; Wide QRS Tachycardia
Hospital General Universitario Gregorio Marañon
2005-09 PHASE4
NCT00993382 COMPLETED
Arrhythmia Prophylaxis; Ventricular Arrhythmia
Sanofi
2009-09 PHASE2
NCT01229254 COMPLETED
Atrial Fibrillation; Atrial Flutter
Portola Pharmaceuticals
2010-09 PHASE2
NCT00392106 SUSPENDED
Atrial Fibrillation
ProRhythm, Inc.
2006-04 PHASE3
NCT00587483 COMPLETED
Other Intraoperative Cardiac Functional Disturbances During Cardiac Surgery
Mayo Clinic
2007-11
NCT03432663 COMPLETED
Atrial Fibrillation
Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud
2008-08-01 PHASE4
NCT00300495 TERMINATED
Atrial Fibrillation; Lung Cancer
Beth Israel Deaconess Medical Center
2006-02 PHASE3
NCT00668759 COMPLETED
Atrial Fibrillation
Advanz Pharma
2008-04 PHASE3
NCT00724581 UNKNOWN
Atrial Fibrillation
Aarhus University Hospital
2008-08 PHASE4
NCT00784316 COMPLETED
Atrial Fibrillation; Cardiac Surgery
Kuopio University Hospital
2007-08 PHASE4
NCT01461733 COMPLETED
Atrial Fibrillation
Ottawa Hospital Research Institute
2007-07 PHASE4
NCT00845780 COMPLETED
Persistent Atrial Fibrillation
University Medical Center Groningen
2000-08 PHASE4
NCT00739193 WITHDRAWN
Blood Pressure
Prism Pharmaceuticals
2008-08 PHASE2
NCT00420017 COMPLETED
Atrial Fibrillation; Esophagectomy
Indiana University
2005-09 PHASE4
NCT00489736 COMPLETED
Atrial Fibrillation
Sanofi
2007-06 PHASE3
NCT00121524 COMPLETED
Cardiac Arrest
Petter Andreas Steen
2003-01 PHASE2
NCT01198275 COMPLETED
Atrial Fibrillation
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
2006-01 PHASE3
NCT00127712 COMPLETED
Atrial Fibrillation
Indiana University
2004-09 PHASE4
NCT00654290 COMPLETED
Atrial Fibrillation
Shiraz University of Medical Sciences
2007-03
NCT00313443 COMPLETED
Arrhythmia; Atrial Fibrillation; Atrial Flutter
Hopital Lariboisière
2006-04 PHASE4
NCT00420953 COMPLETED
Healthy
Prism Pharmaceuticals
2006-12-18 PHASE1
NCT00540787 COMPLETED
Paroxysmal Atrial Fibrillation
Biosense Webster, Inc.
2003-08-01 PHASE4
NCT02171026 COMPLETED
Healthy
Boehringer Ingelheim
2006-04 PHASE1
NCT00233441 COMPLETED
Atrial Fibrillation; Atrial Flutter
Sanofi
2004-12 PHASE2; PHASE3
NCT00007605 COMPLETED
Atrial Fibrillation; Cerebrovascular Accident; Death, Sudden
US Department of Veterans Affairs
1998-04 PHASE3
NCT00000464 COMPLETED
Arrhythmia; Cardiovascular Diseases; Heart Arrest; Heart Diseases; Myocardial Infarction; Ventricular Fibrillation
University of Washington
1987-04 PHASE3
NCT00392431 COMPLETED
Persistant Atrial Fibrillation
University Medical Center Groningen
2003-01
NCT00257959 COMPLETED
Ventricular Tachycardia
Connolly, Stuart, M.D.
2001-01 PHASE4
NCT00000556 COMPLETED
Arrhythmia; Atrial Fibrillation; Cardiovascular Diseases; Heart Diseases
National Heart, Lung, and Blood Institute (NHLBI)
1995-03 PHASE3
NCT00000609 COMPLETED
Arrhythmia; Cardiovascular Diseases; Death, Sudden, Cardiac; Heart Diseases; Heart Failure, Congestive; Heart Failure
National Heart, Lung, and Blood Institute (NHLBI)
1997-05 PHASE3
NCT00272636 COMPLETED
Atrial Fibrillation
University of Michigan
2002-11
NCT00287209 COMPLETED
Atrial Fibrillation; Coronary Artery Bypass Grafting
University of Aarhus
2004-01 PHASE4
NCT00251706 COMPLETED
Atrial Fibrillation
University of Calgary
1999-02 PHASE3
NCT00000531 COMPLETED
Arrhythmia; Cardiovascular Diseases; Death, Sudden, Cardiac; Heart Diseases; Tachycardia, Ventricular; Ventricular Fibrillation
National Heart, Lung, and Blood Institute (NHLBI)
1992-09 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-02-17)

Check the Amiodarone HCl product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Amiodarone HCl functions as a potassium channel and sodium/potassium-ATPase inhibitor, which alters transmembrane ionic flux, prolongs the cardiac action potential duration, and stimulates cellular autophagy. This electrophysiological stabilization suppresses ectopic pacemaker activity and stabilizes membrane potential, providing direct clinical utility in converting and managing cardiac dysrhythmias such as atrial fibrillation and supraventricular tachycardia.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Note: Technical data last updated: Sep 1, 2026.