Treatment of Orthostatic Intolerance

Summary

This trial is designed to study the effects of various mechanistically unique medications in controlling excessive increases in heart rate with standing and in improving the symptoms of orthostatic intolerance in patients with this disorder.

Conditions

• Tachycardia
• Chronic Orthostatic Intolerance

Interventions

DRUG

Acetazolamide

250 mg PO x 1

DRUG

Atomoxetine

10-40 mg PO x 1 dose

OTHER

NO Drug

No intervention - just monitoring

DRUG

Clonidine

Clonidine 0.05-0.3 mg PO x 1 dose

DRUG

Entacapone

Entacapone 200-400 mg PO x 1 dose

DRUG

Entacapone & Propranolol

Entacapone 200-400 mg PO x 1 dose AND propranolol 20 mg PO x 1 dose

DRUG

Atomoxetine & Propranolol

Atomoxetine 10-40 mg PO x 1 dose AND propranolol 20 mg PO x 1 dose

DRUG

Indomethacin

Indomethacin 25-50 mg PO x 1 dose

DRUG

Mecamylamine

mecamylamine 1.25-5 mg PO x 1 dose

DRUG

Isosorbide Dinitrate

Isosorbide dinitrate 5-20 mg PO x 1 dose

DIETARY_SUPPLEMENT

Melatonin

melatonin 3 mg PO x 1 dose

DRUG

Midodrine

midodrine 2.5-10 mg PO x 1 dose

DRUG

Modafinil

modafinil 100-200 mg PO x 1 dose

DRUG

Octreotide

octreotide 12.5-50 mcg Subcutaneous x 1 dose

RADIATION

Placebo

lactose tablet x 1 pill

DRUG

Propranolol

Propranolol 10-80 mg PO x 1-2 dose

DRUG

Modafinil & Propranolol

Modafinil 100-200 mg PO x 1 dose AND Propranolol 20 mg PO x 1 dose

DRUG

Sertraline

sertraline 25-50 mg PO x 1 dose

PROCEDURE

IV Saline

1 liter IV over 2 hours

OTHER

Drinking Water

16 fluid ounces

DEVICE

Breathing Device

Breathing through a dead space tube

DRUG

memantine

memantine 5-20 mg PO x 1 dose

DEVICE

Abdominal binder

Using large blood pressure cuffs linked together, they are wrapped around the subjects abdomen and inflated to generate increased pressure to below tolerably threshold.

Sponsors & Collaborators

• National Center for Advancing Translational Sciences (NCATS)

  collaborator NIH

• Satish R. Raj

  lead OTHER

Principal Investigators

• Satish R Raj, MD MSCI · Vanderbilt University School of Medicine

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

1997-04-30

Primary Completion

2029-12-31

Completion

2029-12-31

Countries

• United States

Study Locations