An Early Phase 1 interventional study of Dobutamine in Arrhythmias, Cardiac, sponsored by Northwell Health. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-26.
Sponsored by Northwell Health · Early Phase 1, Interventional, and Diagnostic
Our hypothesis is that Dobutamine will act in a similar fashion to Isoproterenol with respect to cardiac conduction. Our goal is to study the effects of Dobutamine on cardiac conduction and refractoriness during an Electrophysiology study (EPS). At the end of most EPS Isoproterenol is commonly administered in an effort to change the conduction properties of the heart. In our practice we have been using Dobutamine for this purpose for many years. Dobutamine has never been rigorously studied for this indication however. We designed this study to systematically study the effect of various doses of Dobutamine on the parameters of cardiac conduction and refractoriness that are commonly measured during an EPS. We are specifically looking to compare the effect that Dobutamine has on the sinus node with the effect it has on the atrioventricular node. Patients undergoing an EPS at Long Island Jewish Hospital will be recruited and consented. Measurements of various conduction parameters will be taken at baseline as is standard protocol for an EPS. Dobutamine will then be administered at doses of 5mcg/kg/min, 10mcg/kg/min, 15mcg/kg/min and 20mcg/kg/min. At each of these dosages the same conduction parameters will be measured. A comparison will then be made between the conduction parameters at baseline and when the Dobutamine is administered.
885 studies on the registry are indexed under Arrhythmias, Cardiac; 235 are open to participants now.
This study's enrollment of 37 is below the median of 99 across 429 interventional studies indexed under Arrhythmias, Cardiac.
Browse Arrhythmias, Cardiac studies →Northwell Health is the lead sponsor of 463 studies on the registry; 109 are open to participants now.
Of its 40 completed or terminated interventional studies of FDA-regulated products, 20 (50%) have results posted.
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Exclusion Criteria:
Patients with a resting left ventricular outflow gradient > 30mmHg
Patients with severe aortic stenosis
Patients with prior sustained ventricular tachycardia or ventricular fibrillation
Patients who are not able to consent for themselves
Patients with a prior allergic reaction to Dobutamine or any of its compounds including sulfites
Pregnant patients
Patients receiving B-blockers
Measurements of various conduction parameters will be taken at baseline as is standard protocol for an EPS. Dobutamine will then be administered at doses of 5mcg/kg/min, 10mcg/kg/min, 15mcg/kg/min and 20mcg/kg/min. At each of these dosages the same conduction parameters will be measured. A comparison will then be made between the conduction parameters at baseline and when the Dobutamine is administered.
Drug: Dobutamine
Dobutamine will then be administered at doses of 5mcg/kg/min, 10mcg/kg/min, 15mcg/kg/min and 20mcg/kg/min.
The change in sinus cycle length and anterograde atrioventricular node Wenckebach cycle length with Dobutamine
The difference between the change in the sinus cycle length from baseline to the highest dose of Dobutamine compared to the change in the anterograde AV node Wenckebach cycle length from baseline to the highest dose of Dobutamine.
Time frame: The sinus cycle length and anterograde AV node Wenckebach cycle length will be measured from baseline and at the end of 5 minutes of each dobutamine dose of 5mcg/kg/min, 10mcg/kg/min, 15mcg/kg/min and 20mcg/kg/min for a total of 20 minutes.
The change in intervals measured in an EP study with Dobutamine
The relative changes in baseline of escalating doses of Dobutamine on the sinus cycle length (msec), AH interval (msec), HV interval (msec), QRS duration (msec), QTc (msec), AV node Wenckebach cycle length (msec), AV node effective refractory period (msec) and VA block cycle length (msec).
Time frame: The parameters noted above will be measured at baseline and at the end of 5 minutes of each dose of dobutamine at 5mcg/kg/min, 10mcg/kg/min, 15mcg/kg/min and 20mcg/kg/min for a total of 20 minutes.
The change in blood pressure with Dobutamine
The relative changes in baseline of escalating doses of Dobutamine on the blood pressure.
Time frame: The blood pressure will be measured at baseline and at the end of 5 minutes of each dose of dobutamine at 5mcg/kg/min, 10mcg/kg/min, 15mcg/kg/min and 20mcg/kg/min for a total of 20 minutes.
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