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Oral Water Ingestion in Heart Transplant Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Satish R. Raj, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00581321
First received: December 22, 2007
Last updated: January 7, 2013
Last verified: January 2013
History of Changes
  Purpose

In this study the investigators propose to assess the hemodynamic response to the ingestion of 16 fl oz of water. The investigators will test the hypothesis that water ingestion will increase the systemic vascular resistance.


Condition Intervention
Blood Pressure
Cardiac Transplantation
 Dietary Supplement: water

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Acute Hemodynamic Effects of Oral Water in a Stable Cardiac Transplant Population

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • change in total vascular resistance [ Time Frame: 40 min (before to 30 min after water ingestion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • blood pressure [ Time Frame: 40 min ] [ Designated as safety issue: No ]
  • heart rate [ Time Frame: 40 min ] [ Designated as safety issue: No ]
  • plasma norepinephrine [ Time Frame: 40 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2006
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
water ingestion
 Dietary Supplement: water
water 500 ml x 1

Detailed Description:

In this study we propose to assess the hemodynamic response to the ingestion of 16 fl oz of water. We will test the hypothesis that water ingestion will increase the systemic vascular resistance. This study will occur in patients status post cardiac transplantation during their clinical right heart catheterizations. Invasive hemodynamics including cardiac outputs and plasma norepinephrine levels will be measured before and 30 min after the water ingestion.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • s/p cardiac transplantation scheduled for clinical right heart catheterization
  • age > 18 years

Exclusion Criteria:

  • significant tricuspid regurgitation
  • inability to safely swallow 500 ml of water
  • other major medical comorbidities such as advanced renal disease where water ingestion may be harmful to patient
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00581321

Locations
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Tennessee Valley Health Systems (Nashville VA)
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Satish R. Raj
National Institutes of Health (NIH)
Investigators
Principal Investigator: Satish R Raj, MD, MSCI Vanderbilt University
  More Information

No publications provided

Responsible Party: Satish R. Raj, Assistant Professor of Medicine & Cardiology, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00581321     History of Changes
Other Study ID Numbers: 050811, 1 UL1 RR024975
Study First Received: December 22, 2007
Last Updated: January 7, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Vanderbilt University:
water
blood pressure
vascular resistance
cardiac transplantation

ClinicalTrials.gov processed this record on May 19, 2013