NCT00262470

Treatment of Orthostatic Intolerance

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Satish R. Raj · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed description

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. Pilot drug trials are 4h in duration from \~9am -1pm. Different short-acting medications will be used to determine their acute hemodynamic effects in patients with orthostatic intolerance.

Conditions

• Tachycardia
• Chronic Orthostatic Intolerance

Interventions

Type	Name	Description
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.

Timeline

• Start date: 1997-04-01
• Primary completion: 2029-12-01
• Completion: 2029-12-01
• First posted: 2005-12-06
• Last updated: 2025-10-08

Locations

1 site across 1 country: United States