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Dopamine in Orthostatic Tolerance

This study has been terminated.
(This study is being replaced by another protocol.)
Sponsor:
Information provided by (Responsible Party):
Emily M. Garland, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00748228
First received: September 5, 2008
Last updated: June 19, 2012
Last verified: June 2012
History of Changes
  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:

MedlinePlus related topics: Dietary Sodium
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 ]
Enrollment: 22
Study Start Date: November 2004
Estimated Study Completion Date: July 2012
Estimated 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
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

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 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 19, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Postural Orthostatic Tachycardia Syndrome
Autonomic Nervous System Diseases
Nervous System Diseases
Orthostatic Intolerance
Primary Dysautonomias

ClinicalTrials.gov processed this record on March 03, 2015