Pre-diltiazem, Calcium Versus Placebo for Atrial Fibrillation With Rapid Ventricular Response

NCT05691959
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Phase
Phase 2
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Recruitment status
Unknown
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Participants
378
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Lead sponsor
Ascension Health
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Start date
2023-01-26
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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). 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.
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Short title
Pre-diltiazem, Calcium Versus Placebo for Atrial Fibrillation With Rapid Ventricular Response
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Official title
Calcium Administration to Prevent Hypotension Caused by Diltiazem Administration in the Treatment of Atrial Fibrillation With Rapid Ventricular Response
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Unknown
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Phase
Phase 2
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Study type
Interventional
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Completion date
2025-01-31
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First posted
2023-01-20
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Registry last updated
2023-01-20
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Primary completion date
2025-01-31
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Start date
2023-01-26
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Participants
378
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Participant count basis
Estimated
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Planned participants
378
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Protocol amendments
0
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Ascension Health
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05691959
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ClinicalTrials.gov ID
NCT05691959
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masking description
Each formulation is masked by the pharmacy department.
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Hypotension

    Timeframe: Thirty minutes from time of drug administration

    Mean arterial blood pressure less than 70mm Hg

  1. Heart rate

    Timeframe: Thirty minutes from drug administration

    Decrease below 100 beats per minute

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
99 Years
Healthy volunteers
No

Diagnosis of atrial fibrillation with rapid ventricular response (ventricular rate over 100 bpm) due to an electrophysiologic etiology.

-

  1. Unstable, requiring electric cardioversion -hypotensive

    • altered mental status
    • myocardial infarction
    • pulmonary hypertension

  2. Patients at risk of hypercalcemia - renal failure

  3. Know cardiac valvular disease

  4. Allergic to calcium gluconate or diltiazem

  5. 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)
Sources for eligibility
clinicaltrials.gov

Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (2)