Oral Water Ingestion in Heart Transplant Patients

This study is currently recruiting participants.

Verified by Vanderbilt University, February 2009

First Received: December 22, 2007 Last Updated: February 18, 2009 History of Changes

Sponsors and Collaborators:	Vanderbilt University National Institutes of Health (NIH)
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00581321

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

MedlinePlus related topics: Drinking Water Heart Transplantation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Acute Hemodynamic Effects of Oral Water in a Stable Cardiac Transplant Population

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 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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

Contacts

Contact: Satish R. Raj, MD, MSCI

adcresearch@vanderbilt.edu

Locations

United States, Tennessee
Vanderbilt University	Recruiting
Nashville, Tennessee, United States, 37232
Contact: Satish R. Raj, MD, MSCI adcresearch@vanderbilt.edu
Principal Investigator: Satish R. Raj, MD, MSCI
Sub-Investigator: David Robertson, MD
Sub-Investigator: Italo Biaggioni, MD
Sub-Investigator: Sachin Y. Paranjape, BS
Tennessee Valley Health Systems (Nashville VA)	Recruiting
Nashville, Tennessee, United States, 37212
Contact: Satish R. Raj, MD, MSCI adcresearch@vanderbilt.edu
Principal Investigator: Satish R. Raj, MD, MSCI
Sub-Investigator: Jeffrey N. Rottman, MD
Sub-Investigator: Sachin Y. Paranjape, BS

Sponsors and Collaborators

Vanderbilt University

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Satish R Raj, MD, MSCI

Vanderbilt University

More Information

No publications provided

Responsible Party:	Vanderbilt University ( Satish R Raj MD MSCI )
Study ID Numbers:	050811, 1 UL1 RR024975
Study First Received:	December 22, 2007
Last Updated:	February 18, 2009
ClinicalTrials.gov Identifier:	NCT00581321 History of Changes
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 07, 2009