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Dopamine in Orthostatic Tolerance

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ClinicalTrials.gov Identifier: NCT00748228
Recruitment Status : Terminated (This study is being replaced by another protocol.)
First Posted : September 8, 2008
Last Update Posted : June 15, 2015
Sponsor:
Information provided by (Responsible Party):
Emily M. Garland, Vanderbilt University

Study Description
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Brief Summary:
One goal of this study is to determine whether people with different amounts of dopamine-beta-hydroxylase (DBH) have different responses to events that affect blood pressure and heart rate. We will also study whether increasing dietary salt improves symptoms during upright posture. Finally, we will examine whether the dietary sodium level influences serum DBH activity and whether DBH level influences the response to sodium. DBH levels and the function of the sympathetic or involuntary nervous system will be assessed in normal volunteers and in patients with postural tachycardia syndrome (POTS).

Condition or disease Intervention/treatment Phase
Postural Tachycardia Syndrome Dietary Supplement: dietary sodium Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Dopamine in Orthostatic Tolerance
Study Start Date : November 2004
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sodium
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: A
10 mEq/day dietary sodium
 Dietary Supplement: dietary sodium
10 mEq/day
Experimental: B
150 mEq/day dietary sodium
 Dietary Supplement: dietary sodium
150 mEq/day dietary sodium
Experimental: C
300 mEq/day dietary sodium
 Dietary Supplement: dietary sodium
300 mEq/day


Outcome Measures
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Primary Outcome Measures :
  1. plasma dopamine-beta-hydroxylase [ Time Frame: at enrollment and after tests ]
  2. plasma dopamine [ Time Frame: after tests ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Upright plasma norepinephrine > 600 pg/ml, or
  • An increase in heart rate of > 30 beats per minute upon standing, and
  • Withdrawal of all medications for at least 3 days, and
  • No associated medical illness, and
  • Age 18 - 60 years old.

Exclusion Criteria:

  • Older than 60 years of age
  • Routinely taking medications affecting the autonomic nervous system
  • Any chronic illness (cardiac, pulmonary, endocrine, gastrointestinal, rheumatologic) other than POTS
  • Anemia (Hct < 30)
  • Women of childbearing age who are pregnant or nursing
  • Unable to give informed consent
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00748228


Locations
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Emily M Garland, PhD Vanderbilt University
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Vanderbilt Autonomic Dysfunction Center  This link exits the ClinicalTrials.gov site

Responsible Party: Emily M. Garland, Research Assistant Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00748228     History of Changes
Other Study ID Numbers: 040769
HL071784
First Posted: September 8, 2008    Key Record Dates
Last Update Posted: June 15, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Tachycardia
Postural Orthostatic Tachycardia Syndrome
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
 Dopamine
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents