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Dobutamine on the Cardiac Conduction System

Primary Purpose

Arrhythmias, Cardiac

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dobutamine
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Arrhythmias, Cardiac

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Long Island Jewish Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dobutamine

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
January 21, 2020
Last Updated
January 25, 2022
Sponsor
Northwell Health
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1. Study Identification

Unique Protocol Identification Number
NCT04249258
Brief Title
Dobutamine on the Cardiac Conduction System
Official Title
The Effects of Dobutamine on the Cardiac Conduction System: Site-Specific Dose
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 14, 2020 (Actual)
Primary Completion Date
November 20, 2021 (Actual)
Study Completion Date
November 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwell Health

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmias, Cardiac

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dobutamine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dobutamine
Intervention Description
Dobutamine will then be administered at doses of 5mcg/kg/min, 10mcg/kg/min, 15mcg/kg/min and 20mcg/kg/min.
Primary Outcome Measure Information:
Title
The change in sinus cycle length and anterograde atrioventricular node Wenckebach cycle length with Dobutamine
Description
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.
Secondary Outcome Measure Information:
Title
The change in intervals measured in an EP study with Dobutamine
Description
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.
Title
The change in blood pressure with Dobutamine
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Male or female, ages 18-80 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. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Goldner, MD
Organizational Affiliation
Northwell Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Long Island Jewish Hospital
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Dobutamine on the Cardiac Conduction System

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