Treatment of Orthostatic Intolerance

September 20, 2023 updated by: Satish R. Raj
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Acetazolamide
Drug: Acetazolamide
250 mg PO x 1
Other Names:
  • Diamox
Experimental: 2
Atomoxetine
Drug: Atomoxetine
10-40 mg PO x 1 dose
Other Names:
  • Strattera
Drug: Atomoxetine & Propranolol
Atomoxetine 10-40 mg PO x 1 dose AND propranolol 20 mg PO x 1 dose
Other Names:
  • Inderal
  • Strattera
Experimental: 3
NO Drug
Other: NO Drug
No intervention - just monitoring
Experimental: 4
Clonidine
Drug: Clonidine
Clonidine 0.05-0.3 mg PO x 1 dose
Other Names:
  • Catapres
Experimental: 5
Entacapone
Drug: Entacapone
Entacapone 200-400 mg PO x 1 dose
Other Names:
  • Comtan
Drug: Entacapone & Propranolol
Entacapone 200-400 mg PO x 1 dose AND propranolol 20 mg PO x 1 dose
Other Names:
  • Inderal
  • Comtan
Experimental: 6
Indomethacin
Drug: Indomethacin
Indomethacin 25-50 mg PO x 1 dose
Other Names:
  • Indocin
Experimental: 7
Isosorbide Dinitrate
Drug: Isosorbide Dinitrate
Isosorbide dinitrate 5-20 mg PO x 1 dose
Other Names:
  • Isordil
Experimental: 8
Mecamylamine
Drug: Mecamylamine
mecamylamine 1.25-5 mg PO x 1 dose
Other Names:
  • inversine
Experimental: 9
Memantine
Drug: memantine
memantine 5-20 mg PO x 1 dose
Other Names:
  • Namenda
Experimental: 10
Melatonin
Dietary supplement: Melatonin
melatonin 3 mg PO x 1 dose
Experimental: 11
Midodrine
Drug: Midodrine
midodrine 2.5-10 mg PO x 1 dose
Other Names:
  • pro-amatine
Experimental: 12
Modafinil
Drug: Modafinil
modafinil 100-200 mg PO x 1 dose
Other Names:
  • provigil
Drug: Modafinil & Propranolol
Modafinil 100-200 mg PO x 1 dose AND Propranolol 20 mg PO x 1 dose
Other Names:
  • Inderal
  • Provigil
Experimental: 13
Octreotide
Drug: Octreotide
octreotide 12.5-50 mcg Subcutaneous x 1 dose
Other Names:
  • sandostatin
Placebo Comparator: 14
Placebo (lactose tablet)
Radiation: Placebo
lactose tablet x 1 pill
Experimental: 15
Propranolol
Drug: Atomoxetine & Propranolol
Atomoxetine 10-40 mg PO x 1 dose AND propranolol 20 mg PO x 1 dose
Other Names:
  • Inderal
  • Strattera
Drug: Entacapone & Propranolol
Entacapone 200-400 mg PO x 1 dose AND propranolol 20 mg PO x 1 dose
Other Names:
  • Inderal
  • Comtan
Drug: Modafinil & Propranolol
Modafinil 100-200 mg PO x 1 dose AND Propranolol 20 mg PO x 1 dose
Other Names:
  • Inderal
  • Provigil
Drug: Propranolol
Propranolol 10-80 mg PO x 1-2 dose
Other Names:
  • Inderal
Experimental: 16
Sertraline
Drug: Sertraline
sertraline 25-50 mg PO x 1 dose
Other Names:
  • Zoloft
Experimental: 17
Normal Saline (0.9%) 1 liter
Procedure: IV Saline
1 liter IV over 2 hours
Other Names:
  • NaCl solution (0.9%)
Experimental: 18
Drinking Water
Other: Drinking Water
16 fluid ounces
Experimental: 19
Dead Space Breathing Device
Device: Breathing Device
Breathing through a dead space tube
Experimental: Abdominal Binder
Abdominal binder with inflatable pressure over abdomen
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Increase in heart rate with standing
Time Frame: 1-4 hours
1-4 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Sitting heart rate
Time Frame: 1-4 hours
1-4 hours
Standing heart rate
Time Frame: 1-4 hours
1-4 hours
Blood pressure
Time Frame: 1-4 hours
1-4 hours
Decrease in blood pressure with standing
Time Frame: 1-4 hours
1-4 hours
Orthostatic symptoms score
Time Frame: Baseline, 2h, 4h
Baseline, 2h, 4h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Satish R. Raj

Collaborators

National Center for Advancing Translational Sciences (NCATS)

Investigators

  • Principal Investigator: Satish R Raj, MD MSCI, Vanderbilt University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 1997

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

December 5, 2005

First Submitted That Met QC Criteria

December 5, 2005

First Posted (Estimated)

December 6, 2005

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 20, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 008397
  • UL1TR000445 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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