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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 and 15 mins
Awards & highlights
AFF RVR 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.Check my eligibility
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.See study design
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.
AFF RVR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart beats very fast due to atrial fibrillation.
AFF RVR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 and 15 mins
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 and 15 mins
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean Difference in SBP
Secondary outcome measures
Mean change in heart rhythm
AFF RVR 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
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Who is running the clinical trial?
Aurora Health CareLead Sponsor
43 Previous Clinical Trials
16,093 Total Patients Enrolled
3 Trials studying Atrial Fibrillation
265 Patients Enrolled for Atrial Fibrillation
Michael V Cirone, MDPrincipal InvestigatorAdvocate Aurora Health (AAH)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not allergic to the drugs used in this study.I am over 18 years old.You have a left ventricular assist device.My heart beats very fast due to atrial fibrillation.You are pregnant, as confirmed by a positive urine pregnancy test.My blood pressure is stable and not too low.I have heart failure with a low ejection fraction (<40%) or signs of heart failure.I have been diagnosed with a heart rhythm problem like SVT, WPW, or sick sinus syndrome.You have a specific type of heart block called 2nd or 3rd degree atrioventricular block.
Research Study Groups:
This trial has the following groups:- Group 1: Calcium pre-treatment
- Group 2: Placebo
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What possible adverse effects may arise from Calcium pre-treatment?
"Our analysis at Power gave Calcium pre-treatment a score of 3 since the Phase 4 trial status suggests it has been approved."
Answered by AI
Are there current opportunities to partake in this research endeavor?
"Data hosted on clinicaltrials.gov verifies that this investigation is actively seeking participants. Initially posted on November 30th 2022, the trial has been modified as recently as December 15th 2022."
Answered by AI
How many people are being recruited to participate in this clinical experiment?
"Affirmative. Information on clinicaltrials.gov asserts that this medical study, initially posted on November 30th 2022 is now actively recruiting individuals. A total of 92 volunteers are necessary to be enrolled from 1 research facility."
Answered by AI
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