Dopamine in Orthostatic Tolerance - Full Text View

Sponsor:	Vanderbilt University
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00748228

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:	Supportive Care, Open Label, Crossover Assignment
Official Title:	Dopamine in Orthostatic Tolerance

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Dietary Sodium Dietary Supplements Diets

Drug Information available for: Dopamine Dopamine hydrochloride

U.S. FDA Resources

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 ]

Estimated Enrollment:	56
Study Start Date:	November 2004
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental 10 mEq/day dietary sodium	Dietary Supplement: dietary sodium 10 mEq/day
B: Experimental 150 mEq/day dietary sodium	Dietary Supplement: dietary sodium 150 mEq/day dietary sodium
C: Experimental 300 mEq/day dietary sodium	Dietary Supplement: dietary sodium 300 mEq/day

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
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

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:

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

No publications provided

Responsible Party:	Vanderbilt University ( Emily Garland )
Study ID Numbers:	040769, HL071784
Study First Received:	September 5, 2008
Last Updated:	September 5, 2008
ClinicalTrials.gov Identifier:	NCT00748228 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Heart Diseases
Pathologic Processes
Disease
Tachycardia

Syndrome
Cardiovascular Diseases
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on November 30, 2009