Phase 4
N=92
Diltiazem in the Treatment of Atrial Fibrillation or Atrial Flutter With Rapid Ventricular Rate
Atrial Fibrillation With Rapid Ventricular Response · Hypotension Drug-Induced
Bottom Line
View on ClinicalTrials.gov: NCT05661942 ↗Enrolled (actual)
92
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Mean Difference in Systolic Blood Pressure — -11.7500; -19.5385 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Calcium pre-treatment (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Difference in Systolic Blood Pressure |
-7.2273; -13.6667 | — |
| PRIMARY Mean Difference in Systolic Blood Pressure |
-7.2273; -13.6667 | — |
| PRIMARY Mean Difference in Systolic Blood Pressure |
-7.2273; -13.6667 | — |
| SECONDARY Mean Change in Heart Rate |
-43.1136; -33.7949 | — |
| SECONDARY Mean Change in Heart Rate |
-43.1136; -33.7949 | — |
| SECONDARY Mean Change in Heart Rate |
-43.1136; -33.7949 | — |
| SECONDARY Heart Rhythm at 5 Minutes |
36; 29; 7; 9; 1; 1 | — |
| SECONDARY Heart Rhythm at 15 Minutes |
36; 27; 6; 10; 2; 2 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age > 18 years or older
- Able to provide informed consent
- Primary diagnosis AFF with RVR greater than or equal to 120 bpm
Exclusion Criteria
- Pregnancy defined as a positive urine HCG
- Hemodynamically unstable patients (SBP <90, MAP <65)
- Stated history of systolic heart failure with reduced ejection fraction (<40%) or evidence of acute heart failure or reduced EF (peripheral edema, JVD, pulmonary edema) on clinical exam or bedside echo
- Patients with left ventricular assist device
- Sinus node dysfunction or preexcitation with accessory pathway (known diagnosis of SVT, WPW or sick sinus syndrome. Delta waves or other evidence of accessory pathway on EKG)
- 2nd or 3rd degree atrioventricular block
- Allergy or sensitivity to any study drugs
- Previously enrolled in this trial during a different patient encounter
- Non-English speaking
Data sourced from ClinicalTrials.gov (NCT05661942). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.