Diltiazem in the Treatment of Atrial Fibrillation or Atrial Flutter With Rapid Ventricular Rate (AFF RVR)

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

To compare the relative efficacy for calcium pre-treatment in decreasing incidence of drug induced hypotension after diltiazem administration for treatment of AFF with RVR.

Null Hypothesis: There will be no difference between groups in incidence of hypotension after pretreatment with calcium prior to bolus of diltiazem.

Study Overview

• Status: Recruiting
• Conditions: Hypotension Drug-Induced; AFF With RVR; Atrial Fibrillation With Rapid Ventricular Response (Disorder)
• Intervention / Treatment: Drug: Calcium pre-treatment; Other: No Intervention

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 our 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 (ACMC) with a diagnosis of AFF RVR with ventricular rate greater than or equal to 120 bpm from IRB approval to June 1, 2024. Via simple randomization, patients will be administered Calcium pre-treatment vs control prior to diltiazem administration. Calcium gluconate 1gm 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 20mg 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 (SBP) 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 Type: Interventional
• Enrollment (Anticipated): 92
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Michael V Cirone, MD; Phone Number: 708-684-5354; Email: michael.cirone@aah.rog
• Study Contact Backup: Name: Dharati Desai, PharmD; Phone Number: 7733568241; Email: dharati.desai@aah.org

Study Locations

• United States
  • Illinois
    • Oak Lawn, Illinois, United States, 60453
      • Recruiting
      • Advocate Christ Medical Center Emergency Department (ACMC ED)
      • Contact: Michael V Cirone, MD; Phone Number: 708-684-5354; Email: michael.cirone@aah.org
      • Contact: Dharati Desai, PharmD; Email: dharati.desai@aah.org
      • Sub-Investigator: Dharati Desai, PharmD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age > 18 years or older
• Able to provide informed consent
• Primary diagnosis AFF with RVR greater than or equal to 120 bpm

Exclusion Criteria:

• 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
• Allergy or sensitivity to any study drugs
• Previously enrolled in this trial during a different patient encounter
• Non-English speaking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Calcium pre-treatment; Calcium gluconate 1 gram/100ml 0.9% NaCl or 100ml 0.9% NaCl	Drug: Calcium pre-treatment; The intervention is Calcium gluconate 1 gram/100ml 0.9% NaCl or 100ml 0.9% NaCl) over 5 minutes.
Placebo Comparator: Placebo; diluent (NS) vials	Other: No Intervention; Placebo/ no calcium pre-treatment.; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Difference in SBP	The primary endpoint is the Mean difference in SBP evaluated at 5 and 15 minutes after administration of diltiazem bolus. Monitors were set to obtain an automated full set of vitals every 5 minutes after administration of diltiazem.	5 and 15 mins

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in heart rhythm	Secondary endpoints include mean change heart rhythm at 5 and 15 minutes after administration of diltiazem bolus, mean change heart rate at 5 and 15 minutes after administration of diltiazem bolus, adverse effects due to administration of Calcium gluconate and adverse effects due to administration of Diltiazem infusion.	5 and 15 mins

Collaborators and Investigators

• Sponsor: Aurora Health Care
• Investigators: Principal Investigator: Michael V Cirone, MD, Advocate Aurora Health (AAH)

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2022
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): June 1, 2026

Study Registration Dates

• First Submitted: December 15, 2022
• First Submitted That Met QC Criteria: December 15, 2022
• First Posted (Estimate): December 22, 2022

Study Record Updates

• Last Update Posted (Estimate): December 22, 2022
• Last Update Submitted That Met QC Criteria: December 15, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: calcium; diltiazem
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Hypotension; Atrial Flutter; Physiological Effects of Drugs; Calcium-Regulating Hormones and Agents; Calcium
• Other Study ID Numbers: 22.135

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No