Atrial Fibrillation With Rapid Ventricular ResponsePhase 4AFFRVRNCT05661942
Diltiazem in the Treatment of Atrial Fibrillation or Atrial Flutter With Rapid Ventricular Rate
A Phase 4 study testing Calcium pre-treatment in people with Atrial Fibrillation With Rapid Ventricular Response and Hypotension Drug-Induced, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation With Rapid Ventricular Response, Hypotension Drug-Induced
- What is being tested?
- Calcium pre-treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2022to 20 Nov 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years or older
- Able to provide informed consent
- Primary diagnosis AFF with RVR greater than or equal to 120 bpm
Who cannot join
- 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
Show all 9Show fewer
- Allergy or sensitivity to any study drugs
- Previously enrolled in this trial during a different patient encounter
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Advocate Christ Medical Center Emergency Department (ACMC ED)
Oak Lawn, Illinois, 60453
About this study
Official title: Diltiazem in the Treatment of Atrial Fibrillation or Atrial Flutter With Rapid Ventricular Rate (AFF RVR): Comparing Calcium Pre-treatment vs Placebo in Prevention of Diltiazem Induced Hypotension
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.
Read the detailed description
Non-dihydropyridine calcium channel blockers(CCB) are routinely used in the treatment of atrial fibrillation or flutter with rapid ventricular response (AFF with RVR); however, their use can be limited by drug-induced hypotension. This drug induced hypotension limits and complicates CCB use in the treatment of AFF with RVR. Calcium pre-treatment with calcium channel blocker administration has been studied extensively with verapamil administration in preventing drug induced hypotension however, similar studies evaluating calcium pretreatment with diltiazem administration in the prevention of drug-induced hypotension are limited.
The purpose of this study is to compare the relative efficacy and safety for calcium pretreatment with diltiazem in the treatment of AFF with RVR in preventing drug-induced hypotension. This prospective, randomized double-blinded study will evaluate patients who present to the emergency department at Advocate Christ Medical Center with a diagnosis of AFF with RVR with ventricular rate greater than or equal to 120 beats per minute from IRB approval to June 1, 2024. Via simple randomization, patients will be administered calcium pretreatment versus control prior to diltiazem administration. Calcium gluconate 1 gm or 100 mL of normal saline will be administered as an intravenous infusion over 5 minutes followed by bolus diltiazem 0.25 mg/kg IV push (with a 20 mg max) with repeat diltiazem bolus dose after 15 minutes if rate control not achieved 0.35mg/kg IV push. Calcium gluconate will not be administered with repeat doses of diltiazem. Weight-based dosing of diltiazem was most utilized, though some providers may elect to modify based on the clinical scenario. The primary outcome will be the mean difference in systolic blood pressure evaluated at 5 and 15 minutes after administration of diltiazem bolus. Secondary outcomes include decrease in heart rate, conversion to sinus rhythm, and adverse effects of medication administered.
- Being tested
- Calcium pre-treatment, Placebo
- Keywords
- diltiazem, calcium
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium pre-treatmentDrug
The intervention is Calcium gluconate 1 gram/100ml 0.9% NaCl or 100ml 0.9% NaCl) over 5 minutes.
PlaceboOther
Placebo/ no calcium pre-treatment.
| Study group | Role | What they receive |
|---|---|---|
| Calcium pre-treatment | Active comparator | Calcium gluconate 1 gram/100ml 0.9% NaCl or 100ml 0.9% NaCl Receives: Drug: Calcium pre-treatment |
| Placebo | Placebo comparator | diluent (NS) vials Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Difference in Systolic Blood Pressure
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.
Measured: Baseline to 5 Minutes
Mean Difference in Systolic Blood Pressure
Mean 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.
Measured: Baseline to 10 Minutes
Mean Difference in Systolic Blood Pressure
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
Measured: Baseline to 15 Minutes
Secondary outcomes (5)
Mean Change in Heart Rate
Mean 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.
Measured: Baseline to 5 Minutes
Mean Change in Heart Rate
Mean 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.
Measured: Baseline to 10 Minutes
Mean Change in Heart Rate
Mean 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.
Measured: Baseline to 15 Minutes
Heart Rhythm at 5 Minutes
Heart rhythm category after 5 minutes of initial diltiazem administration for treatment of AFF with RVR.
Measured: Baseline to 5 Minutes
Heart Rhythm at 15 Minutes
Heart rhythm category after 15 minutes of initial diltiazem administration for treatment of AFF with RVR.
Measured: Baseline to 15 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start30 Nov 2022
- Primary completion20 Nov 2024
- Study completion20 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atrial Fibrillation With Rapid Ventricular ResponseStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael V Cirone, MD, Principal investigator, Advocate Aurora Health (AAH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05661942
- Sponsor's protocol ID
- IRB00107053
- Other IDs
- 22.135
- Acronym
- AFFRVR
- Status last verified
- Nov 2024
- First submitted
- 15 Dec 2022
- Last updated
- 10 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diltiazem in the Treatment of Atrial Fibrillation or Atrial Flutter With Rapid Ventricular Rate (AFF RVR): Comparing Calcium Pre-treatment vs Placebo in Prevention of Diltiazem Induced Hypotension
- ClinicalTrials.gov ID
- NCT05661942
- Acronym / sponsor ID
- AFFRVR / IRB00107053
- Keywords
- diltiazem, calcium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 20 Nov 2024 (actual)
- Study completion
- 20 Nov 2024 (actual)
- First posted
- 22 Dec 2022 (actual)
- Results
- Posted 10 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Non-dihydropyridine calcium channel blockers(CCB) are routinely used in the treatment of atrial fibrillation or flutter with rapid ventricular response (AFF with RVR); however, their use can be limited by drug-induced hypotension. This drug induced hypotension limits and complicates CCB use in the treatment of AFF with RVR. Calcium pre-treatment with calcium channel blocker administration has been studied extensively with verapamil administration in preventing drug induced hypotension however, similar studies evaluating calcium pretreatment with diltiazem administration in the prevention of drug-induced hypotension are limited.
The purpose of this study is to compare the relative efficacy and safety for calcium pretreatment with diltiazem in the treatment of AFF with RVR in preventing drug-induced hypotension. This prospective, randomized double-blinded study will evaluate patients who present to the emergency department at Advocate Christ Medical Center with a diagnosis of AFF with RVR with ventricular rate greater than or equal to 120 beats per minute from IRB approval to June 1, 2024. Via simple randomization, patients will be administered calcium pretreatment versus control prior to diltiazem administration. Calcium gluconate 1 gm or 100 mL of normal saline will be administered as an intravenous infusion over 5 minutes followed by bolus diltiazem 0.25 mg/kg IV push (with a 20 mg max) with repeat diltiazem bolus dose after 15 minutes if rate control not achieved 0.35mg/kg IV push. Calcium gluconate will not be administered with repeat doses of diltiazem. Weight-based dosing of diltiazem was most utilized, though some providers may elect to modify based on the clinical scenario. The primary outcome will be the mean difference in systolic blood pressure evaluated at 5 and 15 minutes after administration of diltiazem bolus. Secondary outcomes include decrease in heart rate, conversion to sinus rhythm, and adverse effects of medication administered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calcium pre-treatment | Active comparator | Drug: Calcium pre-treatmentCalcium gluconate 1 gram/100ml 0.9% NaCl or 100ml 0.9% NaCl |
| Placebo | Placebo comparator | Other: Placebodiluent (NS) vials |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years or older
- Able to provide informed consent
- Primary diagnosis AFF with RVR greater than or equal to 120 bpm
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium pre-treatmentThe intervention is Calcium gluconate 1 gram/100ml 0.9% NaCl or 100ml 0.9% NaCl) over 5 minutes. | Drug | Calcium pre-treatment |
| PlaceboPlacebo/ no calcium pre-treatment. | Other | Placebo |
Primary outcome
Mean Difference in Systolic Blood Pressure
Time frame: Baseline to 5 Minutes
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.
Mean Difference in Systolic Blood Pressure
Time frame: Baseline to 10 Minutes
Mean 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.
Mean Difference in Systolic Blood Pressure
Time frame: Baseline to 15 Minutes
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
5 secondary outcomes
Mean Change in Heart Rate
Time frame: Baseline to 5 Minutes
Mean Change in Heart Rate
Time frame: Baseline to 10 Minutes
Mean Change in Heart Rate
Time frame: Baseline to 15 Minutes
Heart Rhythm at 5 Minutes
Time frame: Baseline to 5 Minutes
Heart Rhythm at 15 Minutes
Time frame: Baseline to 15 Minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael V Cirone, MD principal investigator
Advocate Aurora Health (AAH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Calcium pre-treatment in people with Atrial Fibrillation With Rapid Ventricular Response and Hypotension Drug-Induced, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Difference in Systolic Blood Pressure (time frame: Baseline to 5 Minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.