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Dopamine in Orthostatic Tolerance

Primary Purpose

Postural Tachycardia Syndrome

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

dietary sodium

About this trial

This is an interventional supportive care trial for Postural Tachycardia Syndrome

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Vanderbilt University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Arm Description

10 mEq/day dietary sodium

150 mEq/day dietary sodium

300 mEq/day dietary sodium

Outcomes

Primary Outcome Measures

plasma dopamine-beta-hydroxylase

plasma dopamine

Secondary Outcome Measures

Full Information

NCT ID

NCT00748228

First Posted

September 5, 2008

Last Updated

June 11, 2015

Sponsor

Vanderbilt University

1. Study Identification

Unique Protocol Identification Number

NCT00748228

Brief Title

Dopamine in Orthostatic Tolerance

Official Title

Dopamine in Orthostatic Tolerance

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Terminated

Why Stopped

This study is being replaced by another protocol.

Study Start Date

November 2004 (undefined)

Primary Completion Date

July 2012 (Actual)

Study Completion Date

July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Vanderbilt University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postural Tachycardia Syndrome

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

10 mEq/day dietary sodium

Arm Title

Arm Type

Experimental

Arm Description

150 mEq/day dietary sodium

Arm Title

Arm Type

Experimental

Arm Description

300 mEq/day dietary sodium

Intervention Type

Dietary Supplement

Intervention Name(s)

dietary sodium

Intervention Description

10 mEq/day

Intervention Type

Dietary Supplement

Intervention Name(s)

dietary sodium

Intervention Description

300 mEq/day

Intervention Type

Dietary Supplement

Intervention Name(s)

dietary sodium

Intervention Description

150 mEq/day dietary sodium

Primary Outcome Measure Information:

Title

plasma dopamine-beta-hydroxylase

Time Frame

at enrollment and after tests

Title

plasma dopamine

Time Frame

after tests

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Emily M Garland, PhD

Organizational Affiliation

Vanderbilt University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vanderbilt University

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

12. IPD Sharing Statement

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Dopamine in Orthostatic Tolerance

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