Diltiazem in the Treatment of Atrial Fibrillation or Atrial Flutter With Rapid Ventricular Rate

Hypotension Drug-Induced Clinical Trial

— AFF RVR  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05661942
• Other study ID #: 22.135
• Status: Recruiting
• Phase: Phase 4
• Start date: November 30, 2022
• Est. completion date: June 2026

Study information

• Verified date: January 2023
• Source: Aurora Health Care
• Contact: Michael V Cirone, MD
• Phone: 708-684-5354
• Email: michael.cirone[@]aah.rog
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: June 2026
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Flutter
• Hypotension
• Hypotension Drug-Induced

Intervention

Drug:
• Calcium pre-treatment
The intervention is Calcium gluconate 1 gram/100ml 0.9% NaCl or 100ml 0.9% NaCl) over 5 minutes.

Other:
• No Intervention
Placebo/ no calcium pre-treatment.

Locations

Country	Name	City	State
United States	Advocate Christ Medical Center Emergency Department (ACMC ED)	Oak Lawn	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Aurora Health Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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