Dobutamine on the Cardiac Conduction System

The Effects of Dobutamine on the Cardiac Conduction System: Site-Specific Dose

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.

Study Overview

• Status: Completed
• Conditions: Arrhythmias, Cardiac
• Intervention / Treatment: Drug: Dobutamine

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New Hyde Park, New York, United States, 11040
      • Long Island Jewish Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, ages 18-80
4. Patients must be diagnosed with a condition that necessitates an EPS. They must also be deemed to be in good enough medical health to be eligible to safely undergo an EPS. Medical eligibility will be determined by the Attending Electrophysiologist performing the EPS.
5. For females of reproductive potential a negative pregnancy tes

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Dobutamine; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.

Collaborators and Investigators

• Sponsor: Northwell Health
• Investigators: Principal Investigator: Bruce Goldner, MD, Northwell Health

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 14, 2020
• Primary Completion (ACTUAL): November 20, 2021
• Study Completion (ACTUAL): November 20, 2021

Study Registration Dates

• First Submitted: January 21, 2020
• First Submitted That Met QC Criteria: January 29, 2020
• First Posted (ACTUAL): January 30, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 26, 2022
• Last Update Submitted That Met QC Criteria: January 25, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Adrenergic Agonists; Cardiotonic Agents; Adrenergic beta-Agonists; Sympathomimetics; Adrenergic beta-1 Receptor Agonists; Dobutamine
• Other Study ID Numbers: 19-0934

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No