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Treatment of Orthostatic Intolerance

Information source: Vanderbilt University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Tachycardia; Chronic Orthostatic Intolerance

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

Phase: Phase 1/Phase 2

Status: Active, not recruiting

Sponsored by: Satish R. Raj

Official(s) and/or principal investigator(s):
Satish R Raj, MD MSCI, Principal Investigator, Affiliation: Vanderbilt University School of Medicine

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.

Clinical Details

Official title: Treatment of Orthostatic Intolerance

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: Increase in heart rate with standing

Secondary outcome:

Sitting heart rate

Standing heart rate

Blood pressure

Decrease in blood pressure with standing

Orthostatic symptoms score

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Vanderbilt University Autonomic Dysfunction Center, Nashville, Tennessee 37232-2195, United States
Additional Information

Vanderbilt University Autonomic Dysfunction Center website

Starting date: April 1997
Last updated: December 18, 2014

Page last updated: August 23, 2015

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