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Treatment of Orthostatic Intolerance

Information source: Vanderbilt University
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Tachycardia; Chronic Orthostatic Intolerance

Intervention: Acetazolamide (Drug); Atomoxetine (Drug); Baseline (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)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: Vanderbilt University

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

Overall contact:
Bonnie K Black, RN NP, Email: adcresearch@vanderbilt.edu

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: Treatment, Non-Randomized, Single Blind (Subject), Placebo Control, Crossover Assignment, Safety/Efficacy Study

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

Bonnie K Black, RN NP, Email: adcresearch@vanderbilt.edu

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

Vanderbilt University Autonomic Dysfunction Center website

Starting date: April 1997
Last updated: June 2, 2008

Page last updated: November 03, 2008

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