Trial Outcomes & Findings for Oral vs Intravenous Diltiazem for Rapid Atrial Fibrillation/Flutter Trial (NCT NCT03472495)
NCT ID: NCT03472495
Last Updated: 2023-03-01
Results Overview
Number of participant achieving heart rate control (defined as: HR \<110 beats/min or conversion to sinus rhythm) at 2 hours after medication administration between oral immediate release and intravenous continuous infusion diltiazem
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
19 participants
Primary outcome timeframe
2 hrs
Results posted on
2023-03-01
Participant Flow
Participant milestones
| Measure |
Oral Immediate Release Diltiazem
Diltiazem immediate release 60mg orally once (Diltiazem oral product)
Diltiazem Oral Product: Diltiazem Immediate Release 60 MG PO Q6H (30 MG PO Q6H if patient is \<60 kg)
|
Continuous Infusion IV Diltiazem
Diltiazem 2.5-5 mg/hour intravenous Titrate by 1.25 mg every 15-60 minutes. Maximum titration dose 15 mg/hour. Titration Goal of HR \<110 (Diltiazem Injectable Product)
Diltiazem Injectable Product: Diltiazem Continuous Infusion Titrated
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
10
|
|
Overall Study
COMPLETED
|
8
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
| Measure |
Oral Immediate Release Diltiazem
Diltiazem immediate release 60mg orally once (Diltiazem oral product)
Diltiazem Oral Product: Diltiazem Immediate Release 60 MG PO Q6H (30 MG PO Q6H if patient is \<60 kg)
|
Continuous Infusion IV Diltiazem
Diltiazem 2.5-5 mg/hour intravenous Titrate by 1.25 mg every 15-60 minutes. Maximum titration dose 15 mg/hour. Titration Goal of HR \<110 (Diltiazem Injectable Product)
Diltiazem Injectable Product: Diltiazem Continuous Infusion Titrated
|
|---|---|---|
|
Overall Study
Treatment no longer indicated
|
1
|
2
|
|
Overall Study
Physician Decision
|
0
|
2
|
Baseline Characteristics
Oral vs Intravenous Diltiazem for Rapid Atrial Fibrillation/Flutter Trial
Baseline characteristics by cohort
| Measure |
Oral Immediate Release Diltiazem
n=9 Participants
Diltiazem immediate release 60mg orally once (Diltiazem oral product)
Diltiazem Oral Product: Diltiazem Immediate Release 60 MG PO Q6H (30 MG PO Q6H if patient is \<60 kg)
|
Continuous Infusion IV Diltiazem
n=10 Participants
Diltiazem 2.5-5 mg/hour intravenous Titrate by 1.25 mg every 15-60 minutes. Maximum titration dose 15 mg/hour. Titration Goal of HR \<110 (Diltiazem Injectable Product)
Diltiazem Injectable Product: Diltiazem Continuous Infusion Titrated
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.7 Years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
58.3 Years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
59.9 Years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
10 participants
n=7 Participants
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 hrsNumber of participant achieving heart rate control (defined as: HR \<110 beats/min or conversion to sinus rhythm) at 2 hours after medication administration between oral immediate release and intravenous continuous infusion diltiazem
Outcome measures
| Measure |
Oral Immediate Release Diltiazem
n=8 Participants
Diltiazem immediate release 60mg orally once (Diltiazem oral product)
Diltiazem Oral Product: Diltiazem Immediate Release 60 MG PO Q6H (30 MG PO Q6H if patient is \<60 kg)
|
Continuous Infusion IV Diltiazem
n=6 Participants
Diltiazem 2.5-5 mg/hour intravenous Titrate by 1.25 mg every 15-60 minutes. Maximum titration dose 15 mg/hour. Titration Goal of HR \<110 (Diltiazem Injectable Product)
Diltiazem Injectable Product: Diltiazem Continuous Infusion Titrated
|
|---|---|---|
|
Heart Rate Control
|
8 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 4 hrsNumber of participants with heart rate or blood pressure adverse events: Heart rate \< 60 beats/min, or systolic blood pressure \<90 mmHg requiring intervention (intravenous fluid bolus, vasopressors, medication discontinuation)
Outcome measures
| Measure |
Oral Immediate Release Diltiazem
n=8 Participants
Diltiazem immediate release 60mg orally once (Diltiazem oral product)
Diltiazem Oral Product: Diltiazem Immediate Release 60 MG PO Q6H (30 MG PO Q6H if patient is \<60 kg)
|
Continuous Infusion IV Diltiazem
n=6 Participants
Diltiazem 2.5-5 mg/hour intravenous Titrate by 1.25 mg every 15-60 minutes. Maximum titration dose 15 mg/hour. Titration Goal of HR \<110 (Diltiazem Injectable Product)
Diltiazem Injectable Product: Diltiazem Continuous Infusion Titrated
|
|---|---|---|
|
Adverse Event Rate
|
1 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 hrsThese variables include: Age, sex, race, weight, history of atrial fibrillation or flutter, history of hypertension, history of congestive heart failure, prior medication therapy, mean initial HR, duration of atrial fibrillation or flutter episode (\<48 hrs or \>48 hrs), mean initial diltiazem dose (mg/kg)
Outcome measures
Outcome data not reported
Adverse Events
Oral Immediate Release Diltiazem
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Continuous Infusion IV Diltiazem
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Oral Immediate Release Diltiazem
n=8 participants at risk
Diltiazem immediate release 60mg orally once (Diltiazem oral product)
Diltiazem Oral Product: Diltiazem Immediate Release 60 MG PO Q6H (30 MG PO Q6H if patient is \<60 kg)
|
Continuous Infusion IV Diltiazem
n=6 participants at risk
Diltiazem 2.5-5 mg/hour intravenous Titrate by 1.25 mg every 15-60 minutes. Maximum titration dose 15 mg/hour. Titration Goal of HR \<110 (Diltiazem Injectable Product)
Diltiazem Injectable Product: Diltiazem Continuous Infusion Titrated
|
|---|---|---|
|
Cardiac disorders
Hypotension
|
12.5%
1/8 • Number of events 1 • 4 hours
self report by participant Only bradycardia (HR \<60 beats/min) or hypotension (SBP \<90 mmHg requiring intervention including IVF bolus administration, vasopressors, or medication discontinuation) related adverse events were recorded. Mortality was not recorded Non-serious adverse events were not recorded
|
0.00%
0/6 • 4 hours
self report by participant Only bradycardia (HR \<60 beats/min) or hypotension (SBP \<90 mmHg requiring intervention including IVF bolus administration, vasopressors, or medication discontinuation) related adverse events were recorded. Mortality was not recorded Non-serious adverse events were not recorded
|
|
Cardiac disorders
Braydcardia
|
12.5%
1/8 • Number of events 1 • 4 hours
self report by participant Only bradycardia (HR \<60 beats/min) or hypotension (SBP \<90 mmHg requiring intervention including IVF bolus administration, vasopressors, or medication discontinuation) related adverse events were recorded. Mortality was not recorded Non-serious adverse events were not recorded
|
0.00%
0/6 • 4 hours
self report by participant Only bradycardia (HR \<60 beats/min) or hypotension (SBP \<90 mmHg requiring intervention including IVF bolus administration, vasopressors, or medication discontinuation) related adverse events were recorded. Mortality was not recorded Non-serious adverse events were not recorded
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place