Trial · NCT03472495
Oral vs Intravenous Diltiazem for Rapid Atrial Fibrillation/Flutter Trial
NCT03472495, Phase 4, Completed, Virginia Commonwealth University; results first posted 2023-03-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Oral vs Intravenous Diltiazem for Rapid Atrial Fibrillation/Flutter Trial. Trials, record NCT03472495. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03472495
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Oral vs Intravenous Diltiazem for Rapid Atrial Fibrillation/Flutter Trial
- NCT number
- NCT03472495
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 19 participants, actual
- Lead sponsor
- Virginia Commonwealth University
- Conditions
- Atrial Fibrillation and Flutter
- Interventions
- Diltiazem Oral Product, Diltiazem Injectable Product
- First posted
- 2018-03-21
- Last updated
- 2023-03-01
- Results first posted
- 2023-03-01
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Heart Rate Control | 2 hrs | 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 |
| Secondary | Adverse Event Rate | 4 hrs | Number 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) |
| Other | Participant Specific Variables Associated With Heart Rate Control in Each Treatment Arm | 4 hrs | These 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) |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Heart Rate Control | 2 hrs | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Adverse Event Rate | 4 hrs | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Participant Specific Variables Associated With Heart Rate Control in Each Treatment Arm | 4 hrs |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Heart Rate Control | Oral Immediate Release Diltiazem | 8 | Participants | ||
| Heart Rate Control | Continuous Infusion IV Diltiazem | 4 | Participants | ||
| Adverse Event Rate | Oral Immediate Release Diltiazem | 1 | Participants | ||
| Adverse Event Rate | Continuous Infusion IV Diltiazem | 0 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Oral Immediate Release Diltiazem | 9 | |
| Overall Study | STARTED | Continuous Infusion IV Diltiazem | 10 | |
| Overall Study | COMPLETED | Oral Immediate Release Diltiazem | 8 | |
| Overall Study | COMPLETED | Continuous Infusion IV Diltiazem | 6 | |
| Overall Study | NOT COMPLETED | Oral Immediate Release Diltiazem | 1 | |
| Overall Study | NOT COMPLETED | Continuous Infusion IV Diltiazem | 4 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Hypotension | Cardiac disorders | Oral Immediate Release Diltiazem | 1 | 8 | 1 |
| serious | Hypotension | Cardiac disorders | Continuous Infusion IV Diltiazem | 0 | 6 | 0 |
| serious | Braydcardia | Cardiac disorders | Oral Immediate Release Diltiazem | 1 | 8 | 1 |
| serious | Braydcardia | Cardiac disorders | Continuous Infusion IV Diltiazem | 0 | 6 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Oral Immediate Release Diltiazem | 0 | 0 |
| Total, all-cause mortality | Continuous Infusion IV Diltiazem | 0 | 0 |
| Total, other adverse events | Oral Immediate Release Diltiazem | 0 | 0 |
| Total, other adverse events | Continuous Infusion IV Diltiazem | 0 | 0 |
| Total, serious adverse events | Oral Immediate Release Diltiazem | 1 | 8 |
| Total, serious adverse events | Continuous Infusion IV Diltiazem | 0 | 6 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Oral Immediate Release Diltiazem vs Continuous Infusion IV Diltiazem: Adverse Event Rate | Trial comparisons |
| Oral Immediate Release Diltiazem vs Continuous Infusion IV Diltiazem: Heart Rate Control | Trial comparisons |
| Oral Immediate Release Diltiazem vs Continuous Infusion IV Diltiazem: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03472495
GET https://conductscience.org/api/trials/v1/NCT03472495/registered