Dopamine in Orthostatic Tolerance
This study has been terminated.
(This study is being replaced by another protocol.)
Sponsor:
Vanderbilt University
Information provided by (Responsible Party):
Emily M. Garland, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00748228
First received: September 5, 2008
Last updated: June 11, 2015
Last verified: June 2015
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Purpose
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 | Intervention |
|---|---|
|
Postural Tachycardia Syndrome |
Dietary Supplement: dietary sodium |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Dopamine in Orthostatic Tolerance |
Resource links provided by NLM:
Further study details as provided by Vanderbilt University:
Primary Outcome Measures:
- plasma dopamine-beta-hydroxylase [ Time Frame: at enrollment and after tests ] [ Designated as safety issue: No ]
- plasma dopamine [ Time Frame: after tests ] [ Designated as safety issue: No ]
| Enrollment: | 22 |
| Study Start Date: | November 2004 |
| Study Completion Date: | July 2012 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Genders Eligible for Study: | Both |
| 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
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: NCT00748228
Please refer to this study by its ClinicalTrials.gov identifier: 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
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 |
| Study First Received: | September 5, 2008 |
| Last Updated: | June 11, 2015 |
| Health Authority: | United States: Institutional Review Board |
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 |
ClinicalTrials.gov processed this record on September 28, 2016