Trial Outcomes & Findings for Diltiazem in the Treatment of Atrial Fibrillation or Atrial Flutter With Rapid Ventricular Rate (NCT NCT05661942)
NCT ID: NCT05661942
Last Updated: 2025-11-10
Results Overview
Mean difference in systolic blood pressure after administration of diltiazem bolus. Monitors were set to obtain an automated full set of vitals every 5 minutes after administration of diltiazem.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
92 participants
Primary outcome timeframe
Baseline to 5 Minutes
Results posted on
2025-11-10
Participant Flow
Participant milestones
| Measure |
Calcium Pre-treatment
Calcium gluconate 1 gram/100ml 0.9% NaCl or 100ml 0.9% NaCl
Calcium pre-treatment: The intervention is Calcium gluconate 1 gram/100ml 0.9% NaCl or 100ml 0.9% NaCl) over 5 minutes.
|
Placebo
diluent (NS) vials
Placebo: Placebo/ no calcium pre-treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
46
|
46
|
|
Overall Study
COMPLETED
|
44
|
39
|
|
Overall Study
NOT COMPLETED
|
2
|
7
|
Reasons for withdrawal
| Measure |
Calcium Pre-treatment
Calcium gluconate 1 gram/100ml 0.9% NaCl or 100ml 0.9% NaCl
Calcium pre-treatment: The intervention is Calcium gluconate 1 gram/100ml 0.9% NaCl or 100ml 0.9% NaCl) over 5 minutes.
|
Placebo
diluent (NS) vials
Placebo: Placebo/ no calcium pre-treatment.
|
|---|---|---|
|
Overall Study
Nine patients were excluded due to change in hemodynamic status and consent withdrawal.
|
2
|
7
|
Baseline Characteristics
Diltiazem in the Treatment of Atrial Fibrillation or Atrial Flutter With Rapid Ventricular Rate
Baseline characteristics by cohort
| Measure |
Calcium Pre-treatment
n=44 Participants
Calcium gluconate 1 gram/100ml 0.9% NaCl or 100ml 0.9% NaCl
Calcium pre-treatment: The intervention is Calcium gluconate 1 gram/100ml 0.9% NaCl or 100ml 0.9% NaCl) over 5 minutes.
|
Placebo
n=39 Participants
diluent (NS) vials
Placebo: Placebo/ no calcium pre-treatment.
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.9545 years
STANDARD_DEVIATION 10.9395 • n=5 Participants
|
68.6923 years
STANDARD_DEVIATION 11.3721 • n=20 Participants
|
67.7711 years
STANDARD_DEVIATION 11.1107 • n=40 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
23 Participants
n=20 Participants
|
43 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
16 Participants
n=20 Participants
|
40 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
8 Participants
n=20 Participants
|
21 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
30 Participants
n=20 Participants
|
60 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
44 participants
n=5 Participants
|
39 participants
n=20 Participants
|
83 participants
n=40 Participants
|
|
Weight (kg)
|
87.1000 kilograms
n=5 Participants
|
90.1500 kilograms
n=20 Participants
|
87.3000 kilograms
n=40 Participants
|
|
Height (cm)
|
167.6000 centimeters
n=5 Participants
|
172.7000 centimeters
n=20 Participants
|
170.2000 centimeters
n=40 Participants
|
|
On rate Control Medicine (yes/no)?
Yes
|
13 Participants
n=5 Participants
|
16 Participants
n=20 Participants
|
29 Participants
n=40 Participants
|
|
On rate Control Medicine (yes/no)?
No
|
31 Participants
n=5 Participants
|
23 Participants
n=20 Participants
|
54 Participants
n=40 Participants
|
|
Which Rate Control Agent?
Metroprolol
|
0 Participants
n=5 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Which Rate Control Agent?
Diltiazem
|
10 Participants
n=5 Participants
|
10 Participants
n=20 Participants
|
20 Participants
n=40 Participants
|
|
Which Rate Control Agent?
Digoxin
|
1 Participants
n=5 Participants
|
2 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Which Rate Control Agent?
Other
|
2 Participants
n=5 Participants
|
2 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Which Rate Control Agent?
Not on Rate Controlled Agent
|
31 Participants
n=5 Participants
|
23 Participants
n=20 Participants
|
54 Participants
n=40 Participants
|
|
On Rhythm Medication for PTA?
Yes
|
0 Participants
n=5 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
On Rhythm Medication for PTA?
No
|
44 Participants
n=5 Participants
|
38 Participants
n=20 Participants
|
82 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Baseline to 5 MinutesMean difference in systolic blood pressure after administration of diltiazem bolus. Monitors were set to obtain an automated full set of vitals every 5 minutes after administration of diltiazem.
Outcome measures
| Measure |
Calcium Pre-treatment
n=44 Participants
Calcium gluconate 1 gram/100ml 0.9% NaCl or 100ml 0.9% NaCl
Calcium pre-treatment: The intervention is Calcium gluconate 1 gram/100ml 0.9% NaCl or 100ml 0.9% NaCl) over 5 minutes.
|
Placebo
n=39 Participants
diluent (NS) vials
Placebo: Placebo/ no calcium pre-treatment.
|
|---|---|---|
|
Mean Difference in Systolic Blood Pressure
|
-11.7500 mmHg
Standard Deviation 15.7689
|
-19.5385 mmHg
Standard Deviation 16.1259
|
PRIMARY outcome
Timeframe: Baseline to 10 MinutesMean difference in systolic blood pressure evaluated after administration of diltiazem bolus. Monitors were set to obtain an automated full set of vitals every 5 minutes after administration of diltiazem.
Outcome measures
| Measure |
Calcium Pre-treatment
n=44 Participants
Calcium gluconate 1 gram/100ml 0.9% NaCl or 100ml 0.9% NaCl
Calcium pre-treatment: The intervention is Calcium gluconate 1 gram/100ml 0.9% NaCl or 100ml 0.9% NaCl) over 5 minutes.
|
Placebo
n=39 Participants
diluent (NS) vials
Placebo: Placebo/ no calcium pre-treatment.
|
|---|---|---|
|
Mean Difference in Systolic Blood Pressure
|
-7.8182 mmHg
Standard Deviation 14.4484
|
-16.2564 mmHg
Standard Deviation 15.0660
|
PRIMARY outcome
Timeframe: Baseline to 15 MinutesMean difference in systolic blood pressure after administration of diltiazem bolus. Monitors were set to obtain an automated full set of vitals every 5 minutes after administration of diltiazem
Outcome measures
| Measure |
Calcium Pre-treatment
n=44 Participants
Calcium gluconate 1 gram/100ml 0.9% NaCl or 100ml 0.9% NaCl
Calcium pre-treatment: The intervention is Calcium gluconate 1 gram/100ml 0.9% NaCl or 100ml 0.9% NaCl) over 5 minutes.
|
Placebo
n=39 Participants
diluent (NS) vials
Placebo: Placebo/ no calcium pre-treatment.
|
|---|---|---|
|
Mean Difference in Systolic Blood Pressure
|
-7.2273 mmHg
Standard Deviation 14.1994
|
-13.6667 mmHg
Standard Deviation 16.1267
|
SECONDARY outcome
Timeframe: Baseline to 5 MinutesMean difference in heart rate evaluated after administration of diltiazem bolus. Monitors were set to obtain an automated full set of vitals every 5 minutes after administration of diltiazem.
Outcome measures
| Measure |
Calcium Pre-treatment
n=44 Participants
Calcium gluconate 1 gram/100ml 0.9% NaCl or 100ml 0.9% NaCl
Calcium pre-treatment: The intervention is Calcium gluconate 1 gram/100ml 0.9% NaCl or 100ml 0.9% NaCl) over 5 minutes.
|
Placebo
n=39 Participants
diluent (NS) vials
Placebo: Placebo/ no calcium pre-treatment.
|
|---|---|---|
|
Mean Change in Heart Rate
|
-37.8864 beats per minute
Standard Deviation 21.5355
|
-36.2564 beats per minute
Standard Deviation 20.6687
|
SECONDARY outcome
Timeframe: Baseline to 10 MinutesMean difference in heart rate evaluated after administration of diltiazem bolus. Monitors were set to obtain an automated full set of vitals every 5 minutes after administration of diltiazem.
Outcome measures
| Measure |
Calcium Pre-treatment
n=44 Participants
Calcium gluconate 1 gram/100ml 0.9% NaCl or 100ml 0.9% NaCl
Calcium pre-treatment: The intervention is Calcium gluconate 1 gram/100ml 0.9% NaCl or 100ml 0.9% NaCl) over 5 minutes.
|
Placebo
n=39 Participants
diluent (NS) vials
Placebo: Placebo/ no calcium pre-treatment.
|
|---|---|---|
|
Mean Change in Heart Rate
|
-43.9545 beats per minute
Standard Deviation 19.6551
|
-35.0000 beats per minute
Standard Deviation 21.5174
|
SECONDARY outcome
Timeframe: Baseline to 15 MinutesMean difference in heart rate evaluated after administration of diltiazem bolus. Monitors were set to obtain an automated full set of vitals every 5 minutes after administration of diltiazem.
Outcome measures
| Measure |
Calcium Pre-treatment
n=44 Participants
Calcium gluconate 1 gram/100ml 0.9% NaCl or 100ml 0.9% NaCl
Calcium pre-treatment: The intervention is Calcium gluconate 1 gram/100ml 0.9% NaCl or 100ml 0.9% NaCl) over 5 minutes.
|
Placebo
n=39 Participants
diluent (NS) vials
Placebo: Placebo/ no calcium pre-treatment.
|
|---|---|---|
|
Mean Change in Heart Rate
|
-43.1136 beats per minute
Standard Deviation 19.1860
|
-33.7949 beats per minute
Standard Deviation 22.2405
|
SECONDARY outcome
Timeframe: Baseline to 5 MinutesHeart rhythm category after 5 minutes of initial diltiazem administration for treatment of AFF with RVR.
Outcome measures
| Measure |
Calcium Pre-treatment
n=44 Participants
Calcium gluconate 1 gram/100ml 0.9% NaCl or 100ml 0.9% NaCl
Calcium pre-treatment: The intervention is Calcium gluconate 1 gram/100ml 0.9% NaCl or 100ml 0.9% NaCl) over 5 minutes.
|
Placebo
n=39 Participants
diluent (NS) vials
Placebo: Placebo/ no calcium pre-treatment.
|
|---|---|---|
|
Heart Rhythm at 5 Minutes
AFF
|
36 Participants
|
29 Participants
|
|
Heart Rhythm at 5 Minutes
AFF RVR
|
7 Participants
|
9 Participants
|
|
Heart Rhythm at 5 Minutes
NSR
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline to 15 MinutesHeart rhythm category after 15 minutes of initial diltiazem administration for treatment of AFF with RVR.
Outcome measures
| Measure |
Calcium Pre-treatment
n=44 Participants
Calcium gluconate 1 gram/100ml 0.9% NaCl or 100ml 0.9% NaCl
Calcium pre-treatment: The intervention is Calcium gluconate 1 gram/100ml 0.9% NaCl or 100ml 0.9% NaCl) over 5 minutes.
|
Placebo
n=39 Participants
diluent (NS) vials
Placebo: Placebo/ no calcium pre-treatment.
|
|---|---|---|
|
Heart Rhythm at 15 Minutes
AFF
|
36 Participants
|
27 Participants
|
|
Heart Rhythm at 15 Minutes
AFF RVR
|
6 Participants
|
10 Participants
|
|
Heart Rhythm at 15 Minutes
NSR
|
2 Participants
|
2 Participants
|
Adverse Events
Calcium Pre-treatment
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Calcium Pre-treatment
n=44 participants at risk
Calcium gluconate 1 gram/100ml 0.9% NaCl or 100ml 0.9% NaCl
Calcium pre-treatment: The intervention is Calcium gluconate 1 gram/100ml 0.9% NaCl or 100ml 0.9% NaCl) over 5 minutes.
|
Placebo
n=39 participants at risk
diluent (NS) vials
Placebo: Placebo/ no calcium pre-treatment.
|
|---|---|---|
|
General disorders
hypotension
|
2.3%
1/44 • Number of events 1 • Adverse event data was collected at the 5 minutes, 10 minutes, and 15 minutes intervals after initiation of diltiazem infusion by the emergency department pharmacy staff associated with this study.
|
2.6%
1/39 • Number of events 1 • Adverse event data was collected at the 5 minutes, 10 minutes, and 15 minutes intervals after initiation of diltiazem infusion by the emergency department pharmacy staff associated with this study.
|
|
General disorders
extravasation via Calcium Gluconate
|
2.3%
1/44 • Number of events 1 • Adverse event data was collected at the 5 minutes, 10 minutes, and 15 minutes intervals after initiation of diltiazem infusion by the emergency department pharmacy staff associated with this study.
|
0.00%
0/39 • Adverse event data was collected at the 5 minutes, 10 minutes, and 15 minutes intervals after initiation of diltiazem infusion by the emergency department pharmacy staff associated with this study.
|
|
General disorders
ringing in ears/chest pressure
|
4.5%
2/44 • Number of events 2 • Adverse event data was collected at the 5 minutes, 10 minutes, and 15 minutes intervals after initiation of diltiazem infusion by the emergency department pharmacy staff associated with this study.
|
2.6%
1/39 • Number of events 1 • Adverse event data was collected at the 5 minutes, 10 minutes, and 15 minutes intervals after initiation of diltiazem infusion by the emergency department pharmacy staff associated with this study.
|
|
General disorders
extravasation via CCB
|
2.3%
1/44 • Number of events 1 • Adverse event data was collected at the 5 minutes, 10 minutes, and 15 minutes intervals after initiation of diltiazem infusion by the emergency department pharmacy staff associated with this study.
|
0.00%
0/39 • Adverse event data was collected at the 5 minutes, 10 minutes, and 15 minutes intervals after initiation of diltiazem infusion by the emergency department pharmacy staff associated with this study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place