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Oral Water Ingestion in Heart Transplant Patients

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ClinicalTrials.gov Identifier: NCT00581321
Recruitment Status : Active, not recruiting
First Posted : December 27, 2007
Last Update Posted : January 26, 2018
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Satish R. Raj, Vanderbilt University Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Blood Pressure Cardiac Transplantation Dietary Supplement: water Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Acute Hemodynamic Effects of Oral Water in a Stable Cardiac Transplant Population
Study Start Date : January 2006
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
water ingestion
Dietary Supplement: water
water 500 ml x 1



Primary Outcome Measures :
  1. change in total vascular resistance [ Time Frame: 40 min (before to 30 min after water ingestion ]

Secondary Outcome Measures :
  1. blood pressure [ Time Frame: 40 min ]
  2. heart rate [ Time Frame: 40 min ]
  3. plasma norepinephrine [ Time Frame: 40 minutes ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00581321


Locations
United States, Tennessee
Tennessee Valley Health Systems (Nashville VA)
Nashville, Tennessee, United States, 37212
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Satish R. Raj
National Center for Research Resources (NCRR)
Investigators
Principal Investigator: Satish R Raj, MD, MSCI Vanderbilt University

Responsible Party: Satish R. Raj, Assistant Professor of Medicine & Cardiology, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00581321     History of Changes
Other Study ID Numbers: 050811
UL1RR024975 ( U.S. NIH Grant/Contract )
First Posted: December 27, 2007    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018

Keywords provided by Satish R. Raj, Vanderbilt University Medical Center:
water
blood pressure
vascular resistance
cardiac transplantation