Atrial Fibrillation With Rapid Ventricular ResponsePhase 2NCT05691959
Pre-diltiazem, Calcium Versus Placebo for Atrial Fibrillation With Rapid Ventricular Response
A Phase 2 study testing Calcium in people with Atrial Fibrillation With Rapid Ventricular Response and Hypotension, run by Ascension Health.
Trial summary
The goal of this randomized double blind controlled trial is to learn about the effects of calcium when it is given prior to diltiazem for patients with atrial fibrillation ( a type of irregular heart beat) who have rapid ventricular response ( a pulse over 100 beats per minute). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Atrial Fibrillation With Rapid Ventricular Response, Hypotension
- What is being tested?
- Calcium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 378 participants
- Where
- No sites listed yet
- Study dates
- 26 Jan 2023to 31 Jan 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Unstable, requiring electric cardioversion -hypotensive
- altered mental status
- myocardial infarction
- pulmonary hypertension
- Patients at risk of hypercalcemia - renal failure
- Know cardiac valvular disease
Show all 12Show fewer
- Allergic to calcium gluconate or diltiazem
- Underlying cardiac disease - sick sinus syndrome
- 2nd/3rd degree atrial ventricular block
- cardiogenic shock
- recent IV beta blocker administration
- accession bypass tract (WPW, short PR)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Calcium Administration to Prevent Hypotension Caused by Diltiazem Administration in the Treatment of Atrial Fibrillation With Rapid Ventricular Response
The goal of this randomized double blind controlled trial is to learn about the effects of calcium when it is given prior to diltiazem for patients with atrial fibrillation ( a type of irregular heart beat) who have rapid ventricular response ( a pulse over 100 beats per minute). Normally diltiazem 0.25mg/kg (max 20mg) is given to slow the heart rate. We will give Placebo versus Calcium Gluconate 2gm given prior to diltiazem.
The main questions it aims to answer are:
Read more
- Does calcium decrease the incidence of low blood pressure (a side effect of diltiazem)?
- How does calcium effect the action of diltiazem? Does it interfere with the desired decrease in heart rate?
Participants will receive either placebo or calcium immediately prior to the administration of diltiazem. Their blood pressure and pulse will be measured:
- prior to study drug administration
- post study drug and prior to diltiazem administration
- 3 minutes post start of diltiazem
- 5 minutes post start of diltiazem
- 10 minutes post start of diltiazem
- 20 minutes post start of diltiazem
- 30 minutes post start of diltiazem
Researchers will compare the placebo group to the calcium group to see if there is a difference in the blood pressure and pulse.
Read the detailed description
Diltiazem, a calcium channel blocker is the standard of care for treatment of stable patients with atrial fibrillation and rapid ventricular response. Many emergency physicians opine that calcium, the "antidote" for calcium channel blockers, when given prior to diltiazem administration, mitigates the common adverse effect of hypotension.
In order to obtain evidence related to this belief, we will study the effects of placebo (normal saline 50ml) versus calcium gluconate (2 grams in normal saline 50ml). Hemodynamically stable patients in afib with rvr will be identified on their arrival to the emergency department. Those who consent to the study will be enrolled and the pharmacy will be contacted to provide a blinded study sample to the patient's bedside. After initial vital signs are recorded the study sample will be infused via pump over a 10 minute period. Vitals will be recorded on its completion and a diltiazem bolus (0.25mg/kg, max 20mg) will be administered. Vitals will be recorded at 3, 5, 10, 20 and 30 minutes post start of diltiazem bolus.
The primary outcome of hypotension will be calculated using rates (frequencies). The rate of hypotension will be compared between the two groups using Chi square analysis. The groups will be compared for similarity using means(sd) and frequencies(percentages). Any variables that differ by group will be controlled for with a multiple logistic regression analysis.
A 35% rate of hypotension is estimated for the placebo group and a hypothesized 22% in the treatment group (a relative 37% decrease). This will require a minimum total sample size of 378 (184/ group) . We may terminate the study earlier if we achieve power.
- Being tested
- Placebo, Calcium
- Keywords
- Atrial Fibrillation, Rapid Ventricular Response, Diltiazem, Calcium Channel Blocker, Calcium, Hypotension, Heart Rate
- Medical subject headings
- Hypotension, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Normal saline
Patients randomized to placebo group will receive Normal Saline 50ml IV.
CalciumDrug
Also called Study drug
Patients randomized to the study group will receive Calcium 2gm in Normal Saline 50ml IV.
| Study group | Role | What they receive |
|---|---|---|
| Normal Saline | Placebo comparator | Normal saline 50 ml intravenous piggyback once over 10 minutes Receives: Drug: Placebo |
| Calcium chloride | Experimental | x grams in 50 ml ivpb once over 10 minutes Receives: Drug: Calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypotension
Mean arterial blood pressure less than 70mm Hg
Measured: Thirty minutes from time of drug administration
Secondary outcomes (1)
Heart rate
Decrease below 100 beats per minute
Measured: Thirty minutes from drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start26 Jan 2023 (estimated)
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation With Rapid Ventricular ResponseStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Placebo Controlled Double Blind Study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 378 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ascension Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Virginia LaBond MD, Ascension Health
- Investigators
- Virginia A LaBond, MS MD, Principal investigator, Ascension Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05691959
- Sponsor's protocol ID
- RMI20220086
- Status last verified
- Jan 2023
- First submitted
- 11 Jan 2023
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barnett JC, Touchon RC. Short-term control of supraventricular tachycardia with verapamil infusion and calcium pretreatment. Chest. 1990 May;97(5):1106-9. doi: 10.1378/chest.97.5.1106.
PubMed 2331904Haft JI, Habbab MA. Treatment of atrial arrhythmias. Effectiveness of verapamil when preceded by calcium infusion. Arch Intern Med. 1986 Jun;146(6):1085-9. doi: 10.1001/archinte.146.6.1085.
PubMed 3718093Kolkebeck T, Abbrescia K, Pfaff J, Glynn T, Ward JA. Calcium chloride before i.v. diltiazem in the management of atrial fibrillation. J Emerg Med. 2004 May;26(4):395-400. doi: 10.1016/j.jemermed.2003.12.020.
PubMed 15093843Lee J, Kim K, Lee CC, Nam YW, Lee JH, Rhee JE, Singer AJ, Kim KS, Ro Y. Low-dose diltiazem in atrial fibrillation with rapid ventricular response. Am J Emerg Med. 2011 Oct;29(8):849-54. doi: 10.1016/j.ajem.2010.03.021. Epub 2010 May 1.
PubMed 20825912Moser LR, Smythe MA, Tisdale JE. The use of calcium salts in the prevention and management of verapamil-induced hypotension. Ann Pharmacother. 2000 May;34(5):622-9. doi: 10.1345/aph.18318.
PubMed 10852091
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcium Administration to Prevent Hypotension Caused by Diltiazem Administration in the Treatment of Atrial Fibrillation With Rapid Ventricular Response
- ClinicalTrials.gov ID
- NCT05691959
- Acronym / sponsor ID
- RMI20220086
- Keywords
- Atrial Fibrillation, Rapid Ventricular Response, Diltiazem, Calcium Channel Blocker, Calcium, Hypotension, Heart Rate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 378 participants (estimated)
- Lead sponsor
- Ascension HealthIndustry (pharma, biotech, devices)
- Study start
- 26 Jan 2023 (estimated)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 20 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized double blind controlled trial is to learn about the effects of calcium when it is given prior to diltiazem for patients with atrial fibrillation ( a type of irregular heart beat) who have rapid ventricular response ( a pulse over 100 beats per minute). Normally diltiazem 0.25mg/kg (max 20mg) is given to slow the heart rate. We will give Placebo versus Calcium Gluconate 2gm given prior to diltiazem.
The main questions it aims to answer are:
- Does calcium decrease the incidence of low blood pressure (a side effect of diltiazem)?
- How does calcium effect the action of diltiazem? Does it interfere with the desired decrease in heart rate?
Participants will receive either placebo or calcium immediately prior to the administration of diltiazem. Their blood pressure and pulse will be measured:
- prior to study drug administration
- post study drug and prior to diltiazem administration
- 3 minutes post start of diltiazem
- 5 minutes post start of diltiazem
- 10 minutes post start of diltiazem
- 20 minutes post start of diltiazem
- 30 minutes post start of diltiazem
Researchers will compare the placebo group to the calcium group to see if there is a difference in the blood pressure and pulse.
Detailed description
Diltiazem, a calcium channel blocker is the standard of care for treatment of stable patients with atrial fibrillation and rapid ventricular response. Many emergency physicians opine that calcium, the "antidote" for calcium channel blockers, when given prior to diltiazem administration, mitigates the common adverse effect of hypotension.
In order to obtain evidence related to this belief, we will study the effects of placebo (normal saline 50ml) versus calcium gluconate (2 grams in normal saline 50ml). Hemodynamically stable patients in afib with rvr will be identified on their arrival to the emergency department. Those who consent to the study will be enrolled and the pharmacy will be contacted to provide a blinded study sample to the patient's bedside. After initial vital signs are recorded the study sample will be infused via pump over a 10 minute period. Vitals will be recorded on its completion and a diltiazem bolus (0.25mg/kg, max 20mg) will be administered. Vitals will be recorded at 3, 5, 10, 20 and 30 minutes post start of diltiazem bolus.
The primary outcome of hypotension will be calculated using rates (frequencies). The rate of hypotension will be compared between the two groups using Chi square analysis. The groups will be compared for similarity using means(sd) and frequencies(percentages). Any variables that differ by group will be controlled for with a multiple logistic regression analysis.
A 35% rate of hypotension is estimated for the placebo group and a hypothesized 22% in the treatment group (a relative 37% decrease). This will require a minimum total sample size of 378 (184/ group) . We may terminate the study earlier if we achieve power.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Placebo Controlled Double Blind Study
| Arm | Type | Receives |
|---|---|---|
| Normal Saline | Placebo comparator | Drug: PlaceboNormal saline 50 ml intravenous piggyback once over 10 minutes |
| Calcium chloride | Experimental | Drug: Calciumx grams in 50 ml ivpb once over 10 minutes |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (12 listed)
- Unstable, requiring electric cardioversion -hypotensive
- Patients at risk of hypercalcemia - renal failure
- Know cardiac valvular disease
- Allergic to calcium gluconate or diltiazem
- Underlying cardiac disease - sick sinus syndrome
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 |
|---|---|---|
| PlaceboAlso: Normal salinePatients randomized to placebo group will receive Normal Saline 50ml IV. | Drug | Normal Saline |
| CalciumAlso: Study drugPatients randomized to the study group will receive Calcium 2gm in Normal Saline 50ml IV. | Drug | Calcium chloride |
Primary outcome
Hypotension
Time frame: Thirty minutes from time of drug administration
Mean arterial blood pressure less than 70mm Hg
1 secondary outcome
Heart rate
Time frame: Thirty minutes from drug administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- Background: PubMed 2331904Barnett JC, Touchon RC. Short-term control of supraventricular tachycardia with verapamil infusion and calcium pretreatment. Chest. 1990 May;97(5):1106-9. doi: 10.1378/chest.97.5.1106.
- Background: PubMed 3718093Haft JI, Habbab MA. Treatment of atrial arrhythmias. Effectiveness of verapamil when preceded by calcium infusion. Arch Intern Med. 1986 Jun;146(6):1085-9. doi: 10.1001/archinte.146.6.1085.
- Background: PubMed 15093843Kolkebeck T, Abbrescia K, Pfaff J, Glynn T, Ward JA. Calcium chloride before i.v. diltiazem in the management of atrial fibrillation. J Emerg Med. 2004 May;26(4):395-400. doi: 10.1016/j.jemermed.2003.12.020.
- Background: PubMed 20825912Lee J, Kim K, Lee CC, Nam YW, Lee JH, Rhee JE, Singer AJ, Kim KS, Ro Y. Low-dose diltiazem in atrial fibrillation with rapid ventricular response. Am J Emerg Med. 2011 Oct;29(8):849-54. doi: 10.1016/j.ajem.2010.03.021. Epub 2010 May 1.
- Background: PubMed 10852091Moser LR, Smythe MA, Tisdale JE. The use of calcium salts in the prevention and management of verapamil-induced hypotension. Ann Pharmacother. 2000 May;34(5):622-9. doi: 10.1345/aph.18318.
- rate control therapyLink provided by the sponsor.
- calcium gluconate drug informationLink provided by the sponsor.
- diltiazem drug informationLink provided by the sponsor.
- 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.
Virginia A LaBond, MS MD principal investigator
Ascension Health
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Calcium in people with Atrial Fibrillation With Rapid Ventricular Response and Hypotension, run by Ascension Health.
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 0 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 20 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Virginia A LaBond, MS MD (810-606-5000, virginia.labond@ascension.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypotension (time frame: Thirty minutes from time of drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05691959, which also lists 5 linked publications.
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 20 Jan 2023.