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Dopamine in Orthostatic Tolerance

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Vanderbilt University

Status

Terminated

Conditions

Postural Tachycardia Syndrome

Treatments

Dietary Supplement: dietary sodium

Study type

Interventional

Funder types

Other

Identifiers

NCT00748228
HL071784
040769

Details and patient eligibility

About

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).

Enrollment

22 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

22 participants in 3 patient groups

A
Experimental group
Description:
10 mEq/day dietary sodium
Treatment:
Dietary Supplement: dietary sodium
Dietary Supplement: dietary sodium
Dietary Supplement: dietary sodium
B
Experimental group
Description:
150 mEq/day dietary sodium
Treatment:
Dietary Supplement: dietary sodium
Dietary Supplement: dietary sodium
Dietary Supplement: dietary sodium
C
Experimental group
Description:
300 mEq/day dietary sodium
Treatment:
Dietary Supplement: dietary sodium
Dietary Supplement: dietary sodium
Dietary Supplement: dietary sodium

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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