Treatment of Orthostatic Intolerance

Phase 1

Active, not recruiting

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

• Registration Number: NCT00262470
• Lead Sponsor: Satish R. Raj

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1997-04
• Study First Submitted: 2005-12-05
• Study First Submitted QC: 2005-12-05
• Study First Posted: 2005-12-06
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-02
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Atomoxetine & Propranolol	Atomoxetine
15	Entacapone & Propranolol	Propranolol
12	Modafinil & Propranolol	Modafinil
2	Atomoxetine	Atomoxetine
1	Acetazolamide	Acetazolamide
10	Melatonin	Melatonin
3	NO Drug	NO Drug
7	Isosorbide Dinitrate	Isosorbide Dinitrate
14	Placebo	Placebo (lactose tablet)
15	Modafinil & Propranolol	Propranolol
19	Breathing Device	Dead Space Breathing Device
5	Entacapone & Propranolol	Entacapone
18	Drinking Water	Drinking Water
15	Atomoxetine & Propranolol	Propranolol
17	IV Saline	Normal Saline (0.9%) 1 liter
Abdominal Binder	Abdominal binder	Abdominal binder with inflatable pressure over abdomen
6	Indomethacin	Indomethacin
11	Midodrine	Midodrine
8	Mecamylamine	Mecamylamine
4	Clonidine	Clonidine
5	Entacapone	Entacapone
9	memantine	Memantine
12	Modafinil	Modafinil
13	Octreotide	Octreotide
15	Propranolol	Propranolol
16	Sertraline	Sertraline

Primary Outcome Measures

Name	Time	Method
Increase in heart rate with standing	1-4 hours

Secondary Outcome Measures

Name	Time	Method
Sitting heart rate	1-4 hours
Decrease in blood pressure with standing	1-4 hours
Blood pressure	1-4 hours
Orthostatic symptoms score	Baseline, 2h, 4h
Standing heart rate	1-4 hours

Trial Locations

Locations (1)

Vanderbilt University Autonomic Dysfunction Center; 🇺🇸 Nashville, Tennessee, United States