7 completed, 2 terminated, 1 active not recruiting, 1 suspended. 5 Phase 1, 2 Not applicable, 2 Phase 3, 2 Phase 4, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 5 | Completed 4, Terminated 1 |
| Not applicable | 2 | Active not recruiting 1, Completed 1 |
| Phase 3 | 2 | Suspended 1, Terminated 1 |
| Phase 4 | 2 | Completed 1, Withdrawn 1 |
| Phase 2 | 1 | Terminated 1 |
Follow dofetilide: new trials by email Literature Review of dofetilide trials Research Report on dofetilide
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Pulsed Field Ablation (PFA) vs Anti-Arrhythmic Drug (AAD) Therapy as a First Line Treatment for Persistent Atrial Fibrillation FARAPULSE™ Pulsed Field Ablation (PFA) System, Anti-Arrhythmic Drug (AAD): Flecainide, Sotalol, Propafenone, Dofetilide, and Dronedarone - Persistent Atrial Fibrillation | Not applicable | Active not recruiting | Boston Scientific Corporation | 484 | 2023-12-28 | 2026-08-28 |
| Study of LQT-1213 on QTc-induced Prolongation in Healthy Adult Subjects (Part1) and on Congenital Long QT in Patients Diagnosed With Type 2 or 3 Long QT Syndrome (Part 2). LQT-1213, Placebo, Dofetilide 250 μg Cap - Long QT Syndrome | Phase 1 / Phase 2 | Terminated | Thryv Therapeutics, Inc. | 42 | 2023-03-12 | 2025-07-24 |
| Improvement in Endothelial Dysfunction After Initiation of Anti-arrhythmic Therapy in Atrial Fibrillation Patients Sotalol, Dofetilide - Atrial Fibrillation | Completed | Samir Saba | 12 | 2019-05-01 | 2021-01-14 | |
| CiPA Phase 1 ECG Biomarker Validation Study Ranolazine, Verapamil, Lopinavir / Ritonavir - Drug-induced QT Prolongation, Pharmacokinetics | Phase 1 | Completed | Food and Drug Administration (FDA) | 60 | 2017-03-14 | 2020-01-18 |
| Effect of Oral GS-6615 on Dofetilide-Induced QT Prolongation, Safety, and Tolerability in Healthy Adults GS-6615, Placebo to match GS-6615, Placebo to match dofetilide - Long QT Syndrome | Phase 1 | Completed | Gilead Sciences | 60 | 2015-02-01 | 2015-05-20 |
| Ability of Late Sodium or Calcium Current Block to Balance the ECG Effects of Potassium Current Block Dofetilide, Mexiletine, Lidocaine - Drug-induced QT Prolongation, Pharmacokinetics | Phase 1 | Completed | Food and Drug Administration (FDA) | 22 | 2014-05-01 | 2016-06-08 |
| Genetics of QT Prolongation With Antiarrhythmics Dofetilide and/or sotalol - Long QT Syndrome, Drug Toxicity | Unknown | Massachusetts General Hospital | 1000 | 2014-01-01 | 2022-04-04 | |
| Study of the Electrocardiographic Effects of Ranolazine, Dofetilide, Verapamil, and Quinidine in Healthy Subjects Ranolazine, Dofetilide, Verapamil - Drug-induced Surface ECG Changes | Phase 1 | Completed | Food and Drug Administration (FDA) | 22 | 2013-05-01 | 2018-03-08 |
| Catheter Ablation for Recently Diagnosed Paroxysmal Atrial Fibrillation Antiarrhythmic drug, Catheter ablation - Atrial Fibrillation | Phase 4 | Withdrawn | Valley Health System | 2011-12-01 | 2014-12-16 | |
| AV Node Ablation and Pacemaker Therapy Compared to Drug Therapy for Atrial Fibrillation - Pilot Study FDA approved rate and rhythm control drugs, AV Node ablation and device implant - Atrial Fibrillation, Heart Failure | Phase 3 | Terminated | Mayo Clinic | 27 | 2007-12-01 | 2013-04-04 |
| A Study of the Effectiveness of Anti-Arrhythmic Medications After Atrial Fibrillation Ablation propafenone; flecainide; sotalol; dofetilide, Radiofrequency catheter ablation - Atrial Fibrillation | Not applicable | Completed | University of Pennsylvania | 110 | 2006-11-01 | 2013-03-07 |
| High Intensity Focused Ultrasound (HIFU) Ablation System Study propafenone, flecainide, dofetilide - Atrial Fibrillation | Phase 3 | Suspended | ProRhythm, Inc. | 240 | 2006-04-01 | 2008-06-17 |
| A Comparison of Antiarrhythmic Drug Therapy and Radio Frequency Catheter Ablation in Patients With Paroxysmal Atrial Fibrillation Radiofrequency ablation, antiarrhythmic drugs, Amiodarone, flecainide, propafenone, quinidine, dofetilide, sotalol, cibenzoline, beta blocking and calcium channel blocking agents and antiarrhythmic drugs, ThermoCool Radiofrequency Catheter - Paroxysmal Atrial Fibrillation | Phase 4 | Completed | Biosense Webster, Inc. | 112 | 2003-08-01 | 2025-02-28 |
Atrial Fibrillation (7) · Long QT Syndrome (3) · Arrhythmias, Cardiac (1) · Cardiovascular Diseases (1) · Drug-Related Side Effects and Adverse Reactions (1) · Heart Diseases (1) · Heart Failure (1)
Food and Drug Administration (FDA) (3) · Biosense Webster, Inc. (1) · Boston Scientific Corporation (1) · Gilead Sciences (1) · Massachusetts General Hospital (1) · Mayo Clinic (1) · ProRhythm, Inc. (1) · Samir Saba (1) · Thryv Therapeutics, Inc. (1) · University of Pennsylvania (1) · Valley Health System (1)
United States (11) · Canada (2) · France (2) · Australia (1) · Austria (1) · Belgium (1) · Croatia (1) · Czechia (1) · Germany (1) · Hong Kong (1) · Italy (1) · Russia (1) · Singapore (1) · Spain (1) · Switzerland (1)
Carlos Sanabria, MD (3) · Christopher Newton-Cheh, MD, MPH (1) · Edward P. Gerstenfeld, MD (1) · Evegny Pokushalou, MD (1) · Hugh Calkins, MD (1) · Jan Matousek, DO (1) · Jonathan Steinberg, MD (1) · Kimberly B Patel, MD (1) · Oussama Wazni, M.D. (1) · Pierre Jais, MD (1) · Samir Saba, MD (1) · Warren Jackman, MD (1) · Win K Shen, MD (1)
PMID 28036330, PMID 28036334, PMID 19029470, PMID 19738139, PMID 21076158, PMID 25054430, PMID 25870186, PMID 26259627, PMID 26324176, PMID 28213480, PMID 30447156, PMID 42041224
R01HL143070 (1)