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

NCT05661942 | Completed Phase 4 Results DMC FDA Drug

• 2 other identifiers: IRB0010705322.135
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation With Rapid Ventricular Response; Hypotension Drug-Induced

Keywords

diltiazem; calcium

Outcome Measures

Primary Outcomes (3)

• Mean Difference in Systolic Blood Pressure

  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.

  Baseline to 5 Minutes

• Mean Difference in Systolic Blood Pressure

  Mean difference in systolic blood pressure evaluated after administration of diltiazem bolus. Monitors were set to obtain an automated full set of vitals every 5 minutes after administration of diltiazem.

  Baseline to 10 Minutes

• Mean Difference in Systolic Blood Pressure

  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

  Baseline to 15 Minutes

Secondary Outcomes (5)

• Mean Change in Heart Rate

  Baseline to 5 Minutes

• Mean Change in Heart Rate

  Baseline to 10 Minutes

• Mean Change in Heart Rate

  Baseline to 15 Minutes

• Heart Rhythm at 5 Minutes

  Baseline to 5 Minutes

• Heart Rhythm at 15 Minutes

  Baseline to 15 Minutes

Study Arms (2)

Calcium pre-treatment

ACTIVE COMPARATOR

Calcium gluconate 1 gram/100ml 0.9% NaCl or 100ml 0.9% NaCl

Drug: Calcium pre-treatment

Placebo

PLACEBO COMPARATOR

diluent (NS) vials

Other: Placebo

Interventions

Calcium pre-treatment DRUG

The intervention is Calcium gluconate 1 gram/100ml 0.9% NaCl or 100ml 0.9% NaCl) over 5 minutes.

Calcium pre-treatment

Placebo OTHER

Placebo/ no calcium pre-treatment.

Placebo

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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)
• nd 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Advocate Christ Medical Center Emergency Department (ACMC ED)

Oak Lawn, Illinois, 60453, United States

Location

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

Limitations: this was a single-center study with a relatively small sample size, which may limit generalizability. There was variability in diltiazem dosing amongst providers. Additionally, variability in provider practice and in dosing and timing of administration was present with the use of magnesium sulfate for atrial flutter with rapid ventricular rate. The timing and dose of magnesium administration was not protocolized.

Results Point of Contact

• Title: Michael Cirone, MD
• Organization: Advocate Health

michael.cirone@aah.org

7086841710

Study Officials

• Michael V Cirone, MD

  Advocate Aurora Health (AAH)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: December 22, 2022
• Study Start: November 30, 2022
• Primary Completion: November 20, 2024
• Study Completion: November 20, 2024
• Last Updated: November 10, 2025
• Results First Posted: November 10, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)