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

Phase 4

Completed

Conditions: Atrial Fibrillation With Rapid Ventricular Response
Hypotension Drug-Induced

Interventions: Drug: Calcium pre-treatment
Other: Placebo

Registration Number: NCT05661942

Lead Sponsor: Wake Forest University Health Sciences

Brief Summary: The purpose of this study is to see how well calcium pre-treatment works for decreasing incidence of drug-induced hypotension after diltiazem administration for treatment of atrial flutter with rapid ventricular rate.

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 this 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 with a diagnosis of AFF with RVR with ventricular rate greater than or equal to 120 beats per minute from IRB approval to June 1, 2024. Via simple randomization, patients will be administered calcium pretreatment versus control prior to diltiazem administration. Calcium gluconate 1 gm 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 20 mg 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 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 & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 92

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Calcium pre-treatment	Calcium pre-treatment	Calcium gluconate 1 gram/100ml 0.9% NaCl or 100ml 0.9% NaCl
Placebo	Placebo	diluent (NS) vials

Primary Outcome Measures

Name	Time	Method
Mean Difference in Systolic Blood Pressure	Baseline to 15 Minutes	Mean difference in systolic blood pressure after administration of diltiazem bolus. Monitors were set to obtain an automated full set of vitals every 5 minutes after administration of diltiazem

Secondary Outcome Measures

Name	Time	Method
Mean Change in Heart Rate	Baseline to 15 Minutes	Mean difference in heart rate evaluated after administration of diltiazem bolus. Monitors were set to obtain an automated full set of vitals every 5 minutes after administration of diltiazem.
Heart Rhythm at 5 Minutes	Baseline to 5 Minutes	Heart rhythm category after 5 minutes of initial diltiazem administration for treatment of AFF with RVR.
Heart Rhythm at 15 Minutes	Baseline to 15 Minutes	Heart rhythm category after 15 minutes of initial diltiazem administration for treatment of AFF with RVR.

Trial Locations

Locations (1): Advocate Christ Medical Center Emergency Department (ACMC ED)
🇺🇸
Oak Lawn, Illinois, United States
Advocate Christ Medical Center Emergency Department (ACMC ED)
🇺🇸Oak Lawn, Illinois, United States