At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 92 enrolled
Drug / intervention
Calcium pre-treatment +1 moredrug
Likely dose
Calcium pre-treatment 100mlfrom 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.
Diltiazem in the Treatment of Atrial Fibrillation or Atrial Flutter With Rapid Ventricular Rate (AFF RVR): Comparing Calcium Pre-treatment vs Placebo in Prevention of Diltiazem Induced Hypotension
In Brief
A Phase 4 clinical trial evaluating Calcium pre-treatment and Placebo for Atrial Fibrillation With Rapid Ventricular Response and Hypotension Drug-Induced. Completed, enrolled 92 participants across 1 site.
Detailed Summary
The purpose of this study is to see how well calcium pre-treatment works for decreasing incidence of drug-induced hypotension after diltiazem administration for treatment of atrial flutter with rapid ventricular rate.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
2023202420252026
Enrollment StartNov 2022
First PostedDec 2022
Primary CompletionNov 2024
TodayJul 2026
First PostedDec 22, 2022
Enrollment StartNov 30, 2022
Primary CompletionNov 20, 2024
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 3.5 years ago
Interventions
Calcium pre-treatmentdrug
The intervention is Calcium gluconate 1 gram/100ml 0.9% NaCl or 100ml 0.9% NaCl) over 5 minutes.
Placeboother
Placebo/ no calcium pre-treatment.