Dopamine in Orthostatic Tolerance - Tabular View

Tracking Information

First Received Date ^ICMJE

September 5, 2008

Last Updated Date

September 5, 2008

Start Date ^ICMJE

November 2004

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Dopamine in Orthostatic Tolerance

Official Title ^ICMJE

Dopamine in Orthostatic Tolerance

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).

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Supportive Care, Open Label, Crossover Assignment

Condition ^ICMJE

Postural Tachycardia Syndrome

Intervention ^ICMJE

Dietary Supplement: dietary sodium

Study Arms / Comparison Groups

Experimental: 10 mEq/day dietary sodium
Experimental: 150 mEq/day dietary sodium
Experimental: 300 mEq/day dietary sodium

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2010

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00748228

Responsible Party

Emily Garland, Vanderbilt University

Study ID Numbers ^ICMJE

040769, HL071784

Study Sponsor ^ICMJE

Vanderbilt University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Emily M Garland, PhD

Vanderbilt University

Information Provided By

Vanderbilt University

Verification Date

September 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP