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

NCT05691959 | Unknown Phase 2 FDA Drug

• 1 other identifier: RMI20220086
• Study Type: interventional
• Target: 378
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Atrial Fibrillation With Rapid Ventricular Response; Hypotension

Keywords

Atrial Fibrillation; Rapid Ventricular Response; Diltiazem; Calcium Channel Blocker; Calcium; Hypotension; Heart Rate

Outcome Measures

Primary Outcomes (1)

• Hypotension

  Mean arterial blood pressure less than 70mm Hg

  Thirty minutes from time of drug administration

Secondary Outcomes (1)

• Heart rate

  Thirty minutes from drug administration

Study Arms (2)

Normal Saline

PLACEBO COMPARATOR

Normal saline 50 ml intravenous piggyback once over 10 minutes

Drug: Placebo

Calcium chloride

EXPERIMENTAL

x grams in 50 ml ivpb once over 10 minutes

Drug: Calcium

Interventions

Placebo DRUG

Patients randomized to placebo group will receive Normal Saline 50ml IV.

Also known as: Normal saline

Normal Saline

Calcium DRUG

Patients randomized to the study group will receive Calcium 2gm in Normal Saline 50ml IV.

Also known as: Study drug

Calcium chloride

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Unstable, requiring electric cardioversion -hypotensive
• altered mental status
• myocardial infarction
• pulmonary hypertension
• Patients at risk of hypercalcemia - renal failure
• Know cardiac valvular disease
• Allergic to calcium gluconate or diltiazem
• Underlying cardiac disease - sick sinus syndrome
• nd/3rd degree atrial ventricular block
• cardiogenic shock
• recent IV beta blocker administration
• accession bypass tract (WPW, short PR)

Sponsors & Collaborators

• Ascension Health: lead

Related Publications (5)

• 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.

  PMID: 2331904 BACKGROUND

• Haft 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.

  PMID: 3718093 BACKGROUND

• Kolkebeck 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.

  PMID: 15093843 BACKGROUND

• Lee 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.

  PMID: 20825912 BACKGROUND

• Moser 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.

  PMID: 10852091 BACKGROUND

Related Links

• rate control therapy
• calcium gluconate drug information
• diltiazem drug information

MeSH Terms

Conditions

Hypotension; Atrial Fibrillation

Interventions

Saline Solution; Calcium; Drug Evaluation

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors; Drug Development; Investigative Techniques; Evaluation Studies as Topic

Study Officials

• Virginia A LaBond, MS MD

  Ascension Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Virginia A LaBond, MS MD

CONTACT

810-606-5000; virginia.labond@ascension.org

Tara Knisley, MD

CONTACT

810-606-5000; tara.knisley@ascension.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Each formulation is masked by the pharmacy department.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Core Faculty/Research Advisor, Emergency Medicine Residency Program

Model Details: Randomized Placebo Controlled Double Blind Study

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: January 20, 2023
• Study Start: January 26, 2023
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: January 20, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share