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)
Mechanism and Biochemical Profile
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>).