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

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
|
- plasma dopamine-beta-hydroxylase [ Time Frame: at enrollment and after tests ]
- plasma dopamine [ Time Frame: after tests ]

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

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
United States, Tennessee | |
Vanderbilt University | |
Nashville, Tennessee, United States, 37232 |
Principal Investigator: | Emily M Garland, PhD | Vanderbilt University |
Additional Information:
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 |