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NCT00262470 Clinical Trial

Treatment of Orthostatic Intolerance

Tachycardia Clinical Trial

Official title:
Treatment of Orthostatic Intolerance

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00262470
Other study ID # 008397
Secondary ID UL1TR000445
Status Active, not recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date April 1997
Est. completion date December 2025

Study information
Verified date September 2023
Source Vanderbilt University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 150
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Acetazolamide
250 mg PO x 1
• 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
• Entacapone
Entacapone 200-400 mg PO x 1 dose
• Entacapone & Propranolol
Entacapone 200-400 mg PO x 1 dose AND propranolol 20 mg PO x 1 dose
• Atomoxetine & Propranolol
Atomoxetine 10-40 mg PO x 1 dose AND propranolol 20 mg PO x 1 dose
• Indomethacin
Indomethacin 25-50 mg PO x 1 dose
• Mecamylamine
mecamylamine 1.25-5 mg PO x 1 dose
• 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
• Modafinil
modafinil 100-200 mg PO x 1 dose
• 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
• Modafinil & Propranolol
Modafinil 100-200 mg PO x 1 dose AND Propranolol 20 mg PO x 1 dose
• 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.

Locations
Country Name City State
United States Vanderbilt University Autonomic Dysfunction Center Nashville Tennessee

Sponsors (2)
Lead Sponsor Collaborator
Satish R. Raj National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Raj SR, Black BK, Biaggioni I, Harris PA, Robertson D. Acetylcholinesterase inhibition improves tachycardia in postural tachycardia syndrome. Circulation. 2005 May 31;111(21):2734-40. doi: 10.1161/CIRCULATIONAHA.104.497594. Epub 2005 May 23. — View Citation

Raj SR, Black BK, Biaggioni I, Paranjape SY, Ramirez M, Dupont WD, Robertson D. Propranolol decreases tachycardia and improves symptoms in the postural tachycardia syndrome: less is more. Circulation. 2009 Sep 1;120(9):725-34. doi: 10.1161/CIRCULATIONAHA. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Increase in heart rate with standing 1-4 hours
Secondary Sitting heart rate 1-4 hours
Secondary Standing heart rate 1-4 hours
Secondary Blood pressure 1-4 hours
Secondary Decrease in blood pressure with standing 1-4 hours
Secondary Orthostatic symptoms score Baseline, 2h, 4h
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