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Diltiazem + Calcium for Atrial Fibrillation/Flutter (AFF RVR Trial)

Phase 4
Recruiting
Led By Michael V Cirone, MD
Research Sponsored by Aurora Health Care
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Primary diagnosis AFF with RVR greater than or equal to 120 bpm
Be older than 18 years old
Must not have
Allergy or sensitivity to any study drugs
Hemodynamically unstable patients (SBP <90, MAP <65)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 and 15 mins
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial looks at whether calcium can lower the risk of low blood pressure when given a drug (diltiazem) to treat AFF with RVR.

Who is the study for?
This trial is for adults over 18 who can consent and have a type of irregular heartbeat called Atrial Fibrillation or Flutter with rapid heart rate. It's not for those previously in the trial, non-English speakers, pregnant women, people with certain heart conditions like severe low blood pressure or failure, or allergies to study drugs.
What is being tested?
The study tests if giving calcium before diltiazem reduces the chance of low blood pressure in patients with fast-beating atrial fibrillation/flutter. Patients are compared: one group gets calcium pre-treatment; another doesn't. The hypothesis is that there will be no difference between groups.
What are the potential side effects?
Potential side effects include hypotension (low blood pressure) which the study specifically aims to investigate by comparing rates between those given calcium beforehand and those who are not.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My heart beats very fast due to atrial fibrillation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not allergic to the drugs used in this study.
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My blood pressure is stable and not too low.
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I have heart failure with a low ejection fraction (<40%) or signs of heart failure.
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I have been diagnosed with a heart rhythm problem like SVT, WPW, or sick sinus syndrome.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 and 15 mins
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 and 15 mins for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean Difference in SBP
Secondary study objectives
Mean change in heart rhythm

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Calcium pre-treatmentActive Control1 Intervention
Calcium gluconate 1 gram/100ml 0.9% NaCl or 100ml 0.9% NaCl
Group II: PlaceboPlacebo Group1 Intervention
diluent (NS) vials

Find a Location

Who is running the clinical trial?

Aurora Health CareLead Sponsor
45 Previous Clinical Trials
16,326 Total Patients Enrolled
Wake Forest University Health SciencesLead Sponsor
1,390 Previous Clinical Trials
2,546,543 Total Patients Enrolled
Michael V Cirone, MDPrincipal InvestigatorAdvocate Aurora Health (AAH)

Media Library

Calcium pre-treatment Clinical Trial Eligibility Overview. Trial Name: NCT05661942 — Phase 4
Low blood pressure Research Study Groups: Calcium pre-treatment, Placebo
Low blood pressure Clinical Trial 2023: Calcium pre-treatment Highlights & Side Effects. Trial Name: NCT05661942 — Phase 4
Calcium pre-treatment 2023 Treatment Timeline for Medical Study. Trial Name: NCT05661942 — Phase 4
~0 spots leftby Nov 2024
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