Feasibility and Safety of IV Sotalol Administered as a Loading Dose to Initiate Oral Sotalol Therapy (DASH-AF)

Kansas City Heart Rhythm Research Foundation

Status and phase: Unknown; Phase 4

Conditions: Atrial Fibrillation; Arrhythmias, Cardiac

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04473807

KCHRF-DASH-AF-0002

Details and patient eligibility

About

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.

Full description

This is an open-label single arm study investigating the safety and feasibility of an intravenous loading regimen of sotalol to initiate patients on oral sotalol therapy. Informed Consent will be obtained from all patients prior to enrollment in the study. Patients will be admitted to the hospital in accordance with standard hospital protocol for oral sotalol loading.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

80 participants in 1 patient group

DASH-AF

Other group

Description:

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.

Treatment:

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