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Water and the Gastropressor Response - Diurnal Variability

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Satish R. Raj, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00581373
First received: December 22, 2007
Last updated: January 7, 2013
Last verified: January 2013
History of Changes
  Purpose

We will test the null hypothesis that there is no diurnal (morning to afternoon)variability in the blood pressure response to the ingestion of water 16 oz.


Condition Intervention
Orthostatic Hypotension
 Other: water 16 fl oz

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Water and the Gastropressor Response - Diurnal Variability (Specific Aim 1.3)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • blood pressure [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • heart rate [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: August 2007
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
water 16 oz
 Other: water 16 fl oz
water 16 fl oz in AM and repeat in late afternoon

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • orthostatic intolerance

Exclusion Criteria:

  • pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00581373

Locations
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Satish R. Raj
Investigators
Principal Investigator: Satish R Raj, MD MSCI Vanderbilt University
  More Information

Additional Information:
Vanderbilt University Autonomic Dysfunction Center  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Satish R. Raj, Assistant Professor of Medicine & Pharmacology, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00581373     History of Changes
Other Study ID Numbers: 060553, Vanderbilt Discovery
Study First Received: December 22, 2007
Last Updated: January 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
water
orthostatic hypotension
blood pressure

Additional relevant MeSH terms:
Hypotension
Hypotension, Orthostatic
Vascular Diseases
Cardiovascular Diseases
 Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2013