CI

At a glance

ClinicalIndex Comparison Record
Phase 4Unknown· 80 target
Drug / intervention
Intravenous Sotalol Administered as a Loading Dose to Initiate Oral Sotalol Therapy in Adult Patients with Atrial Fibrillationdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04473807
NCT04473807Phase 4Unknown
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Feasibility and Safety of Intravenous Sotalol Administered as a Loading Dose to Initiate Oral Sotalol Therapy in Adult Patients With Atrial Fibrillation (DASH-AF)

Kansas City Heart Rhythm Research Foundation·interventional·Posted Jul 16, 2020·Updated Jan 14, 2022

In Brief

A Phase 4 clinical trial evaluating Intravenous Sotalol Administered as a Loading Dose to Initiate Oral Sotalol Therapy in Adult Patients with Atrial Fibrillation for Arrhythmias, Cardiac and Atrial Fibrillation. Targeting 80 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArrhythmias, Cardiac, Atrial Fibrillation
CountriesUnited States
CollaboratorsTexas Cardiac Arrhythmia Research Foundation, Munson Medical Center

Timeline

Phase 4UnknownOverdue
202120222023202420252026
First PostedJul 16, 2020
Enrollment StartJan 2, 2021
Primary CompletionApr 1, 2022
Study CompletionJun 1, 2022
TodayJul 1, 2026
Enrollment to primary: 1.2 yearsPosted 6.0 years ago

Interventions

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

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.