CompletedPhase 4

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

United States92 participantsStarted 2022-11-30

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean Difference in Systolic Blood Pressure

Timeframe: Baseline to 5 Minutes

Mean Difference in Systolic Blood Pressure

Timeframe: Baseline to 10 Minutes

Mean Difference in Systolic Blood Pressure

Timeframe: Baseline to 15 Minutes

Trial details

NCT IDNCT05661942

SponsorWake Forest University Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-20

Results submitted2025-10-02

View on ClinicalTrials.gov More Atrial Fibrillation With Rapid Ventricular Response trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.