Dopamine in Orthostatic Tolerance

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2008 by Vanderbilt University. Recruitment status was Active, not recruiting

First Received on September 5, 2008. No Changes Posted

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:	Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Supportive Care
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

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
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
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:	Emily Garland, Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00748228 History of Changes
Other Study ID Numbers:	040769, HL071784
Study First Received:	September 5, 2008
Last Updated:	September 5, 2008
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

Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
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 February 09, 2012