Clinical trial
Diltiazem in the Treatment of Atrial Fibrillation or Atrial Flutter With Rapid Ventricular Rate (AFF RVR): Comparing Calcium Pre-treatment vs Placebo in Prevention of Diltiazem Induced Hypotension
Name
22.135
Description
To compare the relative efficacy for calcium pre-treatment in decreasing incidence of drug induced hypotension after diltiazem administration for treatment of AFF with RVR.
Null Hypothesis: There will be no difference between groups in incidence of hypotension after pretreatment with calcium prior to bolus of diltiazem.
Trial arms
Trial start
2022-11-30
Estimated PCD
2024-06-01
Trial end
2026-06-01
Status
Recruiting
Phase
Early phase I
Treatment
Calcium pre-treatment
The intervention is Calcium gluconate 1 gram/100ml 0.9% NaCl or 100ml 0.9% NaCl) over 5 minutes.
Arms:
Calcium pre-treatment
No Intervention
Placebo/ no calcium pre-treatment.
Arms:
Placebo
Other names:
Placebo
Size
92
Primary endpoint
Mean Difference in SBP
5 and 15 mins
Eligibility criteria
Inclusion Criteria:
* Age \> 18 years or older
* Able to provide informed consent
* Primary diagnosis AFF with RVR greater than or equal to 120 bpm
Exclusion Criteria:
* Pregnancy defined as a positive urine HCG
* Hemodynamically unstable patients (SBP \<90, MAP \<65)
* Stated history of systolic heart failure with reduced ejection fraction (\<40%) or evidence of acute heart failure or reduced EF (peripheral edema, JVD, pulmonary edema) on clinical exam or bedside echo
* Patients with left ventricular assist device
* Sinus node dysfunction or preexcitation with accessory pathway (known diagnosis of SVT, WPW or sick sinus syndrome. Delta waves or other evidence of accessory pathway on EKG)
* 2nd or 3rd degree atrioventricular block
* Allergy or sensitivity to any study drugs
* Previously enrolled in this trial during a different patient encounter
* Non-English speaking
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 92, 'type': 'ESTIMATED'}}
Updated at
2023-02-02
1 organization
1 product
3 indications
Organization
Aurora Health CareProduct
CalciumIndication
Drug-Induced Hypotension