Recruiting

Sotalol

Sponsor:

Kansas City Heart Rhythm Research Foundation

Code:

NCT04473807

Conditions

Arrhythmias, Cardiac

Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Intravenous Sotalol Administered as a Loading Dose to Initiate Oral Sotalol Therapy in Adult Patients with Atrial Fibrillation

Study Details

Brief summary:

The purpose of this study is to evaluate the safety and feasibility of the IV loading strategy in patients who are selected to receive sotalol.

Conditions

Arrhythmias, Cardiac

Atrial Fibrillation

Study ID

NCT04473807

Start date

Jan 2, 2021

Status verified date

Feb, 2021

Completion date

Jun, 2022

Anticipated

Primary completion date

Apr, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Male and female between 18 - 85 years old
  • Recent (within 1 day) cardioversion for atrial fibrillation with scheduled sotalol therapy
  • History of highly symptomatic atrial fibrillation who are scheduled for sotalol therapy
  • Creatinine clearance ≥60 mL/min
  • Subject has provided informed consent prior to initiation of any study-specific activities/procedures

Exclusion Criteria:

  • Baseline bradycardia (<50 bpm) off all antiarrhythmic drugs and or Atrioventricular nodal blocking drugs
  • Sick sinus syndrome, unless a functioning pacemaker is present.
  • Any known sensitivities to beta-blockers
  • Uncontrolled heart failure
  • Second-degree (Mobitz II, Wenckebach) or third-degree atrioventricular block
  • Recent (within 7 days) surgical or catheter ablation procedure
  • Severe electrolyte abnormalities (including serum K<3.5)
  • Known use of other QTc prolonging drugs (See Appendix A)
  • Recent (within 7 days) sotalol use
  • Baseline QTc >450 ms
  • Severe reactive airway disease - defined as difficulty breathing from bronchial tubes, swelling and overreaction to an irritant
  • History of Torsade de Pointes (TdP)
  • Pregnancy or breastfeeding
  • Left ventricular ejection fraction (LVEF) less than 35%

Study Design

Enrollment

80 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: DASH-AF

Patients with history of highly symptomatic persistent or paroxysmal AF who are scheduled for sotalol therapy once in sinus rhythm will be enrolled in this study.

Interventions

Intravenous Sotalol Administered as a Loading Dose to Initiate Oral Sotalol Therapy in Adult Patients with Atrial Fibrillation

The hypothesis to be tested is that the intravenous loading regimen followed by oral sotalol administration 4 hours after the conclusion of the IV infusion (every 12 hours thereafter) will result in sotalol peak concentrations at the end of IV loading dose (IV to oral loading) which are comparable to the steady state and maximum QTc seen on Day 3 after the last in-hospital oral dose.

Primary outcome measure

  • intravenous loading regimen followed by q12h oral sotalol administration [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Donita Atkins

816-651-1969datkins@kchrf.com

Locations

Kansas City Heart Rhythm Institute

Recruiting

Overland Park, Kansas, United States, 66211

Contacts

Donita Atkins

816-651-1969datkins@kchrf.com

More Information

Sponsor

Kansas City Heart Rhythm Research Foundation

Last update posted

Jan 14, 2022

Last verified

Feb, 2021

Keywords

  • Sotalol, Intravenous, Oral, Arrhythmias, Atrial Fibrillation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kansas City Heart Rhythm Research Foundation on 2022-01-14.