Treatment of Orthostatic Intolerance

Satish R. Raj

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Tachycardia; Chronic Orthostatic Intolerance

Treatments: Other: NO Drug; Procedure: IV Saline; Device: Abdominal binder; Dietary Supplement: Melatonin; Drug: Modafinil; Drug: Sertraline; Drug: Octreotide; Drug: Propranolol; Radiation: Placebo; Drug: Entacapone & Propranolol; Drug: Atomoxetine; Drug: Atomoxetine & Propranolol; Drug: memantine; Drug: Entacapone; Drug: Indomethacin; Device: Breathing Device; Drug: Acetazolamide; Drug: Modafinil & Propranolol; Drug: Isosorbide Dinitrate; Other: Drinking Water; Drug: Clonidine; Drug: Mecamylamine; Drug: Midodrine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00262470

008397

UL1TR000445 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Chronic symptoms (> 6 months) with standing upright

Exclusion criteria

• Obvious cause of hypovolemia or drugs that could worsen tachycardia
• Chronic severe medical conditions such as cancer or ischemic heart disease

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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150 participants in 20 patient groups, including a placebo group

1

Experimental group

Description:

Acetazolamide

Treatment:

Drug: Acetazolamide

2

Experimental group

Description:

Atomoxetine

Treatment:

Drug: Atomoxetine & Propranolol

Drug: Atomoxetine

3

Experimental group

Description:

NO Drug

Treatment:

Other: NO Drug

4

Experimental group

Description:

Clonidine

Treatment:

Drug: Clonidine

5

Experimental group

Description:

Entacapone

Treatment:

Drug: Entacapone

Drug: Entacapone & Propranolol

6

Experimental group

Description:

Indomethacin

Treatment:

Drug: Indomethacin

7

Experimental group

Description:

Isosorbide Dinitrate

Treatment:

Drug: Isosorbide Dinitrate

8

Experimental group

Description:

Mecamylamine

Treatment:

Drug: Mecamylamine

9

Experimental group

Description:

Memantine

Treatment:

Drug: memantine

10

Experimental group

Description:

Melatonin

Treatment:

Dietary Supplement: Melatonin

11

Experimental group

Description:

Midodrine

Treatment:

Drug: Midodrine

12

Experimental group

Description:

Modafinil

Treatment:

Drug: Modafinil & Propranolol

Drug: Modafinil

13

Experimental group

Description:

Octreotide

Treatment:

Drug: Octreotide

14

Placebo Comparator group

Description:

Placebo (lactose tablet)

Treatment:

Radiation: Placebo

15

Experimental group

Description:

Propranolol

Treatment:

Drug: Modafinil & Propranolol

Drug: Atomoxetine & Propranolol

Drug: Entacapone & Propranolol

Drug: Propranolol

16

Experimental group

Description:

Sertraline

Treatment:

Drug: Sertraline

17

Experimental group

Description:

Normal Saline (0.9%) 1 liter

Treatment:

Procedure: IV Saline

18

Experimental group

Description:

Drinking Water

Treatment:

Other: Drinking Water

19

Experimental group

Description:

Dead Space Breathing Device

Treatment:

Device: Breathing Device

Abdominal Binder

Experimental group

Description:

Abdominal binder with inflatable pressure over abdomen

Treatment:

Device: Abdominal binder