Oral Water Ingestion in Heart Transplant Patients

• Sponsor: Satish R. Raj (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT00581321
• Collaborator: National Center for Research Resources (NCRR) (NIH)
• Enrollment: 40
• Locations: 2
• Arm: 1
• Duration (Months): 239
• Patients Per Site: 20
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: N/A
• 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: Jan 1, 2006
• Anticipated Primary Completion Date: Dec 1, 2025
• Anticipated Study Completion Date: Dec 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. change in total vascular resistance [40 min (before to 30 min after water ingestion]

Secondary Outcome Measures

1. blood pressure [40 min]

2. heart rate [40 min]

3. plasma norepinephrine [40 minutes]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Locations

	Site	City	State	Country	Postal Code
1	Tennessee Valley Health Systems (Nashville VA)	Nashville	Tennessee	United States	37212
2	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Satish R. Raj, Assistant Professor of Medicine & Cardiology, Vanderbilt University Medical Center
• ClinicalTrials.gov Identifier: NCT00581321
• Other Study ID Numbers: 050811; UL1RR024975
• First Posted: Dec 27, 2007
• Last Update Posted: Sep 8, 2021
• Last Verified: Sep 1, 2021

• Keywords provided by Satish R. Raj, Assistant Professor of Medicine & Cardiology, Vanderbilt University Medical Center: water; blood pressure; vascular resistance; cardiac transplantation

Study Results

No Results Posted as of Sep 8, 2021