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NCT00748228 Clinical Trial

Dopamine in Orthostatic Tolerance

Postural Tachycardia Syndrome Clinical Trial

Official title:
Dopamine in Orthostatic Tolerance

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00748228
Other study ID # 040769
Secondary ID HL071784
Status Terminated
Phase N/A
First received September 5, 2008
Last updated June 11, 2015
Start date November 2004
Est. completion date July 2012

Study information
Verified date June 2015
Source Vanderbilt University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Terminated
Enrollment 22
Est. completion date July 2012
Est. primary completion date July 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 60 Years
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• dietary sodium
10 mEq/day
• dietary sodium
300 mEq/day
• dietary sodium
150 mEq/day dietary sodium

Locations
Country Name City State
United States Vanderbilt University Nashville Tennessee

Sponsors (1)
Lead Sponsor Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary plasma dopamine-beta-hydroxylase at enrollment and after tests No
Primary plasma dopamine after tests No
See also
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Completed NCT00685919 - Peripheral Dopamine in Postural Tachycardia Syndrome Phase 2/Phase 3
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Recruiting NCT05618054 - Periaqueductal Gray-vagus Nerve Interface Malfunction Explain the Natural History With Its Numerous Co-morbidities? N/A
Completed NCT01366963 - Cognitive Dysfunction in Postural Tachycardia Syndrome N/A
Recruiting NCT05107635 - Inappropriate Sinus Tachycardia Registry
Terminated NCT02154009 - Clinical Autonomic Disorders: A Training Protocol
Completed NCT03602482 - Standing Cognition and Co-morbidities of POTS Evaluation N/A
Completed NCT02167412 - EEG Characteristics in Youth POTS and/or Syncope

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