Dobutamine on the Cardiac Conduction System

Sponsor
Northwell Health (Other)
Overall Status
Completed
CT.gov ID
NCT04249258
Collaborator
(none)
37
1
1
22.2
1.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
37 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
The Effects of Dobutamine on the Cardiac Conduction System: Site-Specific Dose
Actual Study Start Date :
Jan 14, 2020
Actual Primary Completion Date :
Nov 20, 2021
Actual Study Completion Date :
Nov 20, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. The change in sinus cycle length and anterograde atrioventricular node Wenckebach cycle length with 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.]

    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.

Secondary Outcome Measures

  1. The change in intervals measured in an EP study with Dobutamine [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 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).

  2. The change in blood pressure with Dobutamine [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.]

    The relative changes in baseline of escalating doses of Dobutamine on the blood pressure.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Long Island Jewish Hospital New Hyde Park New York United States 11040

Sponsors and Collaborators

  • Northwell Health

Investigators

  • Principal Investigator: Bruce Goldner, MD, Northwell Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Northwell Health
ClinicalTrials.gov Identifier:
NCT04249258
Other Study ID Numbers:
  • 19-0934
First Posted:
Jan 30, 2020
Last Update Posted:
Jan 26, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 26, 2022