NCT00581321

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
44mo left

Started Jan 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Jan 2006Dec 2029

Study Start

First participant enrolled

January 1, 2006

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 27, 2007

Completed
21.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

October 8, 2025

Status Verified

October 1, 2025

Enrollment Period

23.9 years

First QC Date

December 22, 2007

Last Update Submit

October 3, 2025

Conditions

Blood PressureCardiac Transplantation

Keywords

waterblood pressurevascular resistancecardiac transplantation

Outcome Measures

Primary Outcomes (1)

  • change in total vascular resistance

    TPR measured by Modelflow

    40 min (before to 30 min after water ingestion

Secondary Outcomes (3)

  • blood pressure

    40 min

  • heart rate

    40 min

  • plasma norepinephrine

    40 minutes

Study Arms (1)

1

EXPERIMENTAL

water ingestion (16 fl oz within 3 minutes)

Dietary Supplement: water

Interventions

waterDIETARY_SUPPLEMENT

water 500 ml x 1

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • s/p cardiac transplantation scheduled for clinical right heart catheterization
  • age \> 18 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tennessee Valley Health Systems (Nashville VA)

Nashville, Tennessee, 37212, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Satish R Raj, MD, MSCI

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor of Medicine & Cardiology

Study Record Dates

First Submitted

December 22, 2007

First Posted

December 27, 2007

Study Start

January 1, 2006

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

October 8, 2025

Record last verified: 2025-10

Locations

US(2)