The Hemodynamic Response to Prolonged Dobutamine Infusion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01042873
Recruitment Status : Recruiting
First Posted : January 6, 2010
Last Update Posted : July 6, 2011
Information provided by:
Hadassah Medical Organization

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.

Condition or disease Intervention/treatment Phase
Healthy Heart Failure Drug: 3 hours intravenous dobutamine Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Study Start Date : January 2010
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Intravenous dobutamine
3 hours infusion of dobutamine
Drug: 3 hours intravenous dobutamine
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 Measures :
  1. Heart rate [ Time Frame: 3 hours ]

Secondary Outcome Measures :
  1. Systolic blood pressure [ Time Frame: 3 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • healthy subjects

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01042873

Hadassah University Hospital Recruiting
Jerusalem, Israel, 91120
Contact: Mordechai Muszkat, MD    972-2-6777335   
Principal Investigator: Mordechai Muszkat, MD         
Sponsors and Collaborators
Hadassah Medical Organization

Responsible Party: Mordechai Muszkat, MD, Hadassah-Hebrew University Medical Center Identifier: NCT01042873     History of Changes
Other Study ID Numbers: 0355-09-HMO-CTIL
0355-09-HMO ( Other Identifier: HadassahMO )
First Posted: January 6, 2010    Key Record Dates
Last Update Posted: July 6, 2011
Last Verified: June 2011

Keywords provided by Hadassah Medical Organization:
beta adrenergic receptors
Healthy subjects

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Cardiotonic Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents