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The Hemodynamic Response to Prolonged Dobutamine Infusion

Primary Purpose

Healthy, Heart Failure

Status

Unknown status

Phase

Phase 4

Locations

Israel

Study Type

Interventional

Intervention

3 hours intravenous dobutamine

About this trial

This is an interventional other trial for Healthy focused on measuring Desensitization, beta adrenergic receptors, Healthy subjects

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

healthy subjects

Exclusion Criteria:

consumption of any medications during the 2 weeks prior to the study
history of chest pain or tachycardia

Sites / Locations

Hadassah University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Intravenous dobutamine

Arm Description

3 hours infusion of dobutamine

Outcomes

Primary Outcome Measures

Heart rate

Secondary Outcome Measures

Systolic blood pressure

Full Information

NCT ID

NCT01042873

First Posted

January 5, 2010

Last Updated

June 11, 2018

Sponsor

Hadassah Medical Organization

1. Study Identification

Unique Protocol Identification Number

NCT01042873

Brief Title

The Hemodynamic Response to Prolonged Dobutamine Infusion

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Unknown status

Study Start Date

January 2010 (undefined)

Primary Completion Date

December 2020 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hadassah Medical Organization

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

A decrease in the response of beta 1 adrenergic receptors to agonists (desensitization) is thought to play a major role in the pathogenesis of diseases such as congestive heart failure. However, currently, there is no in vivo model that will enable us to measure desensitization of the hemodynamic responses to beta 1 adrenergic receptors in vivo. Our hypothesis is that constant 3 hours intravenous infusion of the selective beta1 adrenergic receptor agonist dobutamine will result in gradual decline in hemodynamic responses to dobutamine over time.

6. Conditions and Keywords

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

Healthy, Heart Failure

Keywords

Desensitization, beta adrenergic receptors, Healthy subjects

7. Study Design

Primary Purpose

Other

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intravenous dobutamine

Arm Type

Other

Arm Description

3 hours infusion of dobutamine

Intervention Type

Drug

Intervention Name(s)

3 hours intravenous dobutamine

Intervention Description

Intravenous dobutamine will be infused during 3 hours. At the first and last 0.5 hors of infusion dose will be increased gradually, while in the middle 2 hours dose will remain constant.

Primary Outcome Measure Information:

Title

Heart rate

Time Frame

3 hours

Secondary Outcome Measure Information:

Title

Systolic blood pressure

Time Frame

3 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: healthy subjects Exclusion Criteria: consumption of any medications during the 2 weeks prior to the study history of chest pain or tachycardia

Facility Information:

Facility Name

Hadassah University Hospital

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mordechai Muszkat, MD

Phone

972-2-6777335

muszkatm@hadassah.org.il

First Name & Middle Initial & Last Name & Degree

Mordechai Muszkat, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

16325050

Citation

Bruck H, Leineweber K, Temme T, Weber M, Heusch G, Philipp T, Brodde OE. The Arg389Gly beta1-adrenoceptor polymorphism and catecholamine effects on plasma-renin activity. J Am Coll Cardiol. 2005 Dec 6;46(11):2111-5. doi: 10.1016/j.jacc.2005.08.041. Epub 2005 Nov 4.

Results Reference

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The Hemodynamic Response to Prolonged Dobutamine Infusion

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