Treatment of Orthostatic Intolerance

Sponsor

Satish R. Raj (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT00262470

Collaborator

National Institutes of Health (NIH) (NIH)

150

Enrollment

Location

Arms

344

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Tachycardia Chronic Orthostatic Intolerance	Drug: Acetazolamide Drug: Atomoxetine Other: NO Drug Drug: Clonidine Drug: Entacapone Drug: Entacapone & Propranolol Drug: Atomoxetine & Propranolol Drug: Indomethacin Drug: Mecamylamine Drug: Isosorbide Dinitrate Dietary Supplement: Melatonin Drug: Midodrine Drug: Modafinil Drug: Octreotide Radiation: Placebo Drug: Propranolol Drug: Modafinil & Propranolol Drug: Sertraline Procedure: IV Saline Other: Drinking Water Device: Breathing Device Drug: memantine Device: Abdominal binder	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Treatment of Orthostatic Intolerance

Actual Study Start Date :

Apr 1, 1997

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Acetazolamide	Drug: Acetazolamide 250 mg PO x 1 Other Names: Diamox
Experimental: 2 Atomoxetine	Drug: Atomoxetine 10-40 mg PO x 1 dose Other Names: Strattera Drug: Atomoxetine & Propranolol Atomoxetine 10-40 mg PO x 1 dose AND propranolol 20 mg PO x 1 dose Other Names: Strattera Inderal
Experimental: 3 NO Drug	Other: NO Drug No intervention - just monitoring
Experimental: 4 Clonidine	Drug: Clonidine Clonidine 0.05-0.3 mg PO x 1 dose Other Names: Catapres
Experimental: 5 Entacapone	Drug: Entacapone Entacapone 200-400 mg PO x 1 dose Other Names: Comtan Drug: Entacapone & Propranolol Entacapone 200-400 mg PO x 1 dose AND propranolol 20 mg PO x 1 dose Other Names: Comtan Inderal
Experimental: 6 Indomethacin	Drug: Indomethacin Indomethacin 25-50 mg PO x 1 dose Other Names: Indocin
Experimental: 7 Isosorbide Dinitrate	Drug: Isosorbide Dinitrate Isosorbide dinitrate 5-20 mg PO x 1 dose Other Names: Isordil
Experimental: 8 Mecamylamine	Drug: Mecamylamine mecamylamine 1.25-5 mg PO x 1 dose Other Names: inversine
Experimental: 9 Memantine	Drug: memantine memantine 5-20 mg PO x 1 dose Other Names: Namenda
Experimental: 10 Melatonin	Dietary Supplement: Melatonin melatonin 3 mg PO x 1 dose
Experimental: 11 Midodrine	Drug: Midodrine midodrine 2.5-10 mg PO x 1 dose Other Names: pro-amatine
Experimental: 12 Modafinil	Drug: Modafinil modafinil 100-200 mg PO x 1 dose Other Names: provigil Drug: Modafinil & Propranolol Modafinil 100-200 mg PO x 1 dose AND Propranolol 20 mg PO x 1 dose Other Names: Provigil Inderal
Experimental: 13 Octreotide	Drug: Octreotide octreotide 12.5-50 mcg Subcutaneous x 1 dose Other Names: sandostatin
Placebo Comparator: 14 Placebo (lactose tablet)	Radiation: Placebo lactose tablet x 1 pill
Experimental: 15 Propranolol	Drug: Entacapone & Propranolol Entacapone 200-400 mg PO x 1 dose AND propranolol 20 mg PO x 1 dose Other Names: Comtan Inderal Drug: Atomoxetine & Propranolol Atomoxetine 10-40 mg PO x 1 dose AND propranolol 20 mg PO x 1 dose Other Names: Strattera Inderal Drug: Propranolol Propranolol 10-80 mg PO x 1-2 dose Other Names: Inderal Drug: Modafinil & Propranolol Modafinil 100-200 mg PO x 1 dose AND Propranolol 20 mg PO x 1 dose Other Names: Provigil Inderal
Experimental: 16 Sertraline	Drug: Sertraline sertraline 25-50 mg PO x 1 dose Other Names: Zoloft
Experimental: 17 Normal Saline (0.9%) 1 liter	Procedure: IV Saline 1 liter IV over 2 hours Other Names: NaCl solution (0.9%)
Experimental: 18 Drinking Water	Other: Drinking Water 16 fluid ounces
Experimental: 19 Dead Space Breathing Device	Device: Breathing Device Breathing through a dead space tube
Experimental: Abdominal Binder Abdominal binder with inflatable pressure over abdomen	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.