Overview

This trial is active, not recruiting.

Conditions blood pressure, cardiac transplantation
Treatment water
Sponsor Satish R. Raj
Collaborator National Institutes of Health (NIH)
Start date January 2006
End date December 2013
Trial size 40 participants
Trial identifier NCT00581321, 050811, 1 UL1 RR024975

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
water ingestion
water
water 500 ml x 1

Primary Outcomes

Measure
change in total vascular resistance
time frame: 40 min (before to 30 min after water ingestion

Secondary Outcomes

Measure
blood pressure
time frame: 40 min
heart rate
time frame: 40 min
plasma norepinephrine
time frame: 40 minutes

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Acute Hemodynamic Effects of Oral Water in a Stable Cardiac Transplant Population
Principal investigator Satish R Raj, MD, MSCI
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2013.
Information provided to ClinicalTrials.gov by Vanderbilt University.