NCT06494007CompletedPhase 4
Role of IV Calcium to Prevent Diltiazem-related Hypotension
Reducing Diltiazem-Related Hypotension in Atrial Fibrillation: The Role of IV Calcium Pretreatment
Source: ClinicalTrials.gov · Last updated 11 Jul 2024
Brief summary (registry, in English)
The objective of this study is to examine the efficacy and safety of IV calcium pretreatment at varying doses prior to weight-adjusted IV Diltiazem on the incidence of Diltiazem-related hypotension in adult patients presenting to the Emergency Department due to Atrial Fibrillation with Rapid Ventricular Response. Specifically, we tested the hypothesis that patients with Atrial Fibrillation who receive IV calcium pretreatment prior to IV Diltiazem suffer less hypotension than those receiving Diltiazem monotherapy.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 217 (actual)
- First submitted
- 1 Jul 2024
- Start date
- 1 Jan 2023
- Primary completion date
- 1 Jun 2024
- Lead sponsor
- Haseki Training and Research Hospital
- Diseases
- Atrial fibrillation
- NCT number
- NCT06494007
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 217
- From 1 Jan 2023 to the primary completion date, 1 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with concurrent use of another Heart Rate control agent (such as beta-blockers, amiodarone, or digoxin) on the same admission
Other illness
- Patients with a documented history of sick sinus syndrome, third-degree AV block, Wolff-Parkinson-White syndrome
- Patients with a confirmed allergy to diltiazem
Age
- Patients under 18 years of age
Other
- pregnant individuals
- Patients with hemodynamic instability requiring electrocardioversion
- Patients with hypotension (SBP \<90 mmHg)
- Patients with known or suspected hypercalcemia
Who the study is looking for
- Patients aged ≥ 18 years
- Patients with documented AFib/AFL (confirmed by ECG)
- Patients with a Heart Rate of ≥ 120 bpm, and a Systolic Blood Pressure of ≥ 90 mmHg
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Haseki Training and Research Hospital Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.