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Calcium Channel Blocker
Diltiazem with oral and intravenous treatment for Atrial Fibrillation
Phase 4
Waitlist Available
Research Sponsored by Spectrum Health - Lakeland
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day
Awards & highlights
Study Summary
The primary objective of the study is to reduce hospital admission and decrease time to disposition through establishing an effective treatment protocol for AF and Atrial Flutter in the Emergency Department of Spectrum Health Lakeland. Secondary outcome is to measure if oral diltiazem is an effective HR controlling agent in AF RVR and Flutter.
Eligible Conditions
- Atrial Fibrillation
- Atrial Flutter
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 day
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Admission rate
Time to heart rate less than 110
Secondary outcome measures
Rate of hypotension
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Diltiazem with oral and intravenous treatmentActive Control1 Intervention
Diltiazem 0.25mg/kg injection, give over 2 minutes, max dose 30mg. 15 minutes following Diltiazem Infusion administer oral Diltiazem 60mg IR Tablet, do not give if BP<100
Group II: traditional atrial fibrillation with rapid ventricular responsePlacebo Group1 Intervention
these patients will receive traditional treatments at provider discretion. To be included in teh study their initial heart rate must also be over 125, and they must receive at least one intravenous medication for atrial fibrillation with rapid ventricular response. This will be a heterogenous group of patients receiving digoxin, amiodarone, various beta-blockers, and intravenous diltiazem without oral diltiazem.
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Who is running the clinical trial?
Spectrum Health - LakelandLead Sponsor
12 Previous Clinical Trials
1,355 Total Patients Enrolled
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