Dopamine in Orthostatic Tolerance

NCT ID: NCT00748228

Last Updated: 2015-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2012-07-31

Brief Summary

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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

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Conditions

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Postural Tachycardia Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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A

10 mEq/day dietary sodium

Group Type EXPERIMENTAL

dietary sodium

Intervention Type DIETARY_SUPPLEMENT

10 mEq/day

B

150 mEq/day dietary sodium

Group Type EXPERIMENTAL

dietary sodium

Intervention Type DIETARY_SUPPLEMENT

150 mEq/day dietary sodium

C

300 mEq/day dietary sodium

Group Type EXPERIMENTAL

dietary sodium

Intervention Type DIETARY_SUPPLEMENT

300 mEq/day

Interventions

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dietary sodium

10 mEq/day

Intervention Type DIETARY_SUPPLEMENT

dietary sodium

300 mEq/day

Intervention Type DIETARY_SUPPLEMENT

dietary sodium

150 mEq/day dietary sodium

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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Emily M. Garland

Research Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emily M Garland, PhD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

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Vanderbilt University

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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HL071784

Identifier Type: -

Identifier Source: secondary_id

040769

Identifier Type: -

Identifier Source: org_study_id

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