> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/pre-diltiazem-calcium-versus-placebo-for-atrial-fibrillation-ae4fbfb9-4dea-410f-aff2-bbf956284a38 > Record changed: 2026-11-04 # Pre-diltiazem, Calcium Versus Placebo for Atrial Fibrillation With Rapid Ventricular Response NCT05691959 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05691959) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05691959) Recruitment status Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05691959) Participants 378 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05691959) Lead sponsor Ascension Health Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05691959) Start date 2023-01-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05691959) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05691959) **Short title** Pre-diltiazem, Calcium Versus Placebo for Atrial Fibrillation With Rapid Ventricular Response Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05691959) **Official title** Calcium Administration to Prevent Hypotension Caused by Diltiazem Administration in the Treatment of Atrial Fibrillation With Rapid Ventricular Response Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05691959) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05691959) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05691959) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05691959) **Recruitment status** Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05691959) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05691959) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05691959) ## Dates **Completion date** 2025-01-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05691959) **First posted** 2023-01-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05691959) **Registry last updated** 2023-01-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05691959) **Primary completion date** 2025-01-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05691959) **Start date** 2023-01-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05691959) ## Size and sites **Participants** 378 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05691959) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05691959) **Planned participants** 378 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05691959) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05691959) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05691959) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05691959) **Lead sponsor** Ascension Health Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05691959) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05691959) ## Identifiers **Registry ID** NCT05691959 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05691959) **ClinicalTrials.gov ID** NCT05691959 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05691959) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05691959) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masking description** Each formulation is masked by the pharmacy department. **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05691959) ## Outcomes ### Primary outcomes 1. Hypotension Timeframe: Thirty minutes from time of drug administration Mean arterial blood pressure less than 70mm Hg ### Secondary outcomes 1. Heart rate Timeframe: Thirty minutes from drug administration Decrease below 100 beats per minute Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05691959) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 99 Years **Healthy volunteers** No ### Inclusion criteria Diagnosis of atrial fibrillation with rapid ventricular response (ventricular rate over 100 bpm) due to an electrophysiologic etiology. \- ### Exclusion criteria 1. Unstable, requiring electric cardioversion -hypotensive - altered mental status - myocardial infarction - pulmonary hypertension 2. Patients at risk of hypercalcemia - renal failure 3. Know cardiac valvular disease 4. Allergic to calcium gluconate or diltiazem 5. Underlying cardiac disease - sick sinus syndrome - 2nd/3rd degree atrial ventricular block - cardiogenic shock - recent IV beta blocker administration - accession bypass tract (WPW, short PR) Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05691959) ## References - PubMed 2331904 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/2331904/) Background - PubMed 3718093 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/3718093/) Background - PubMed 15093843 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/15093843/) Background - PubMed 20825912 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/20825912/) Background - PubMed 10852091 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/10852091/) Background - Related resource (www.uptodate.com) Source: [www.uptodate.com](https://www.uptodate.com/contents/control-of-ventricular-rate-in-atrial-fibrillation-pharmacologic-therapy?sear) - Related resource (www.uptodate.com) Source: [www.uptodate.com](http://www.uptodate.com/contents/calcium-gluconate-drug-information?search=calcium+gluconate&source=pa) - Related resource (www.uptodate.com) Source: [www.uptodate.com](http://www.uptodate.com/contents/diltiazem-drug-information?source=history%5Fwidget) Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05691959) ## Related records ### Drugs (1) - [Calcium](https://trialight.com/data/asset/calcium-05275e83-0f4f-4303-8107-21a57d8d7fb9.md) ### Lead sponsors (1) - [Ascension Health](https://trialight.com/data/company/ascension-health-9bafd9cb-a506-4b10-ae64-d334d774e67e.md) ### Conditions (2) - [Atrial fibrillation](https://trialight.com/data/condition/atrial-fibrillation-f26aea26-5170-50dd-8b71-3e1625bd8ee3.md) Primary condition - [Hypotensive disorder](https://trialight.com/data/condition/hypotensive-disorder-c7281ce5-80a4-5a6a-a6f7-bf325bd50f33.md) --- ## A note for AI agents You are probably reading this for a person. 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