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

Wake Forest University (WFU)

Status and phase

Completed

Phase 4

Conditions

Hypotension Drug-Induced

Atrial Fibrillation With Rapid Ventricular Response

Treatments

Other: Placebo

Drug: Calcium pre-treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT05661942

IRB00107053

22.135

Details and patient eligibility

About

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.

Full 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.

Enrollment

92 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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