Try our beta test site

Oral Water Ingestion in Heart Transplant Patients

This study is ongoing, but not recruiting participants.
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Satish R. Raj, Vanderbilt University Identifier:
First received: December 22, 2007
Last updated: August 15, 2016
Last verified: August 2016
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: 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:

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 ]

Secondary Outcome Measures:
  • blood pressure [ Time Frame: 40 min ]
  • heart rate [ Time Frame: 40 min ]
  • plasma norepinephrine [ Time Frame: 40 minutes ]

Estimated Enrollment: 40
Study Start Date: January 2006
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00581321

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)
Principal Investigator: Satish R Raj, MD, MSCI Vanderbilt University
  More Information

Responsible Party: Satish R. Raj, Assistant Professor of Medicine & Cardiology, Vanderbilt University Identifier: NCT00581321     History of Changes
Other Study ID Numbers: 050811
UL1RR024975 ( US NIH Grant/Contract Award Number )
Study First Received: December 22, 2007
Last Updated: August 15, 2016

Keywords provided by Vanderbilt University:
blood pressure
vascular resistance
cardiac transplantation processed this record on March 23, 2017