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NCT00581321 Clinical Trial

Oral Water Ingestion in Heart Transplant Patients

Blood Pressure Clinical Trial

Official title:
Acute Hemodynamic Effects of Oral Water in a Stable Cardiac Transplant Population

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00581321
Other study ID # 050811
Secondary ID UL1RR024975
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 2006
Est. completion date December 2025

Study information
Verified date September 2023
Source Vanderbilt University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 40
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• water
water 500 ml x 1

Locations
Country Name City State
United States Tennessee Valley Health Systems (Nashville VA) Nashville Tennessee
United States Vanderbilt University Nashville Tennessee

Sponsors (2)
Lead Sponsor Collaborator
Satish R. Raj National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary change in total vascular resistance 40 min (before to 30 min after water ingestion
Secondary blood pressure 40 min
Secondary heart rate 40 min
Secondary plasma norepinephrine 40 minutes
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