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Pre-diltiazem, Calcium Versus Placebo for Atrial Fibrillation With Rapid Ventricular Response

NCT05691959 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 378

Last updated 2023-01-20

No results posted yet for this study

Summary

The goal of this randomized double blind controlled trial is to learn about the effects of calcium when it is given prior to diltiazem for patients with atrial fibrillation ( a type of irregular heart beat) who have rapid ventricular response ( a pulse over 100 beats per minute). Normally diltiazem 0.25mg/kg (max 20mg) is given to slow the heart rate. We will give Placebo versus Calcium Gluconate 2gm given prior to diltiazem.

The main questions it aims to answer are:

* Does calcium decrease the incidence of low blood pressure (a side effect of diltiazem)?
* How does calcium effect the action of diltiazem? Does it interfere with the desired decrease in heart rate?

Participants will receive either placebo or calcium immediately prior to the administration of diltiazem. Their blood pressure and pulse will be measured:

* prior to study drug administration
* post study drug and prior to diltiazem administration
* 3 minutes post start of diltiazem
* 5 minutes post start of diltiazem
* 10 minutes post start of diltiazem
* 20 minutes post start of diltiazem
* 30 minutes post start of diltiazem

Researchers will compare the placebo group to the calcium group to see if there is a difference in the blood pressure and pulse.

Conditions

  • Atrial Fibrillation With Rapid Ventricular Response
  • Hypotension

Interventions

DRUG

Placebo

Patients randomized to placebo group will receive Normal Saline 50ml IV.

DRUG

Calcium

Patients randomized to the study group will receive Calcium 2gm in Normal Saline 50ml IV.

Sponsors & Collaborators

  • Ascension Health

    lead INDUSTRY

Principal Investigators

  • Virginia A LaBond, MS MD · Ascension Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-26
Primary Completion
2025-01-31
Completion
2025-01-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05691959 on ClinicalTrials.gov