The Hemodynamic Response to Prolonged Dobutamine Infusion

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2011 by Hadassah Medical Organization
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01042873
First received: January 5, 2010
Last updated: July 3, 2011
Last verified: June 2011
  Purpose

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 Intervention Phase
Healthy
Heart Failure
Drug: 3 hours intravenous dobutamine
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Heart rate [ Time Frame: 3 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Systolic blood pressure [ Time Frame: 3 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: January 2010
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01042873

Locations
Israel
Hadassah University Hospital Recruiting
Jerusalem, Israel, 91120
Contact: Mordechai Muszkat, MD    972-2-6777335    muszkatm@hadassah.org.il   
Principal Investigator: Mordechai Muszkat, MD         
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

Publications:
Responsible Party: Mordechai Muszkat, MD, Hadassah-Hebrew University Medical Center
ClinicalTrials.gov Identifier: NCT01042873     History of Changes
Other Study ID Numbers: 0355-09-HMO-CTIL, 0355-09-HMO
Study First Received: January 5, 2010
Last Updated: July 3, 2011
Health Authority: Israel: Ministry of Health

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Dobutamine
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
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

ClinicalTrials.gov processed this record on August 25, 2014