Oral Water Ingestion in Heart Transplant Patients | NCT00581321

Studies
Oral Water Ingestion in Heart Transplant Patients

NCT00581321

Sponsor

Satish R. Raj

Status

Active, not recruiting

Last Update Posted

Oct 8, 2025Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Blood Pressure
Cardiac Transplantation

Interventions

water

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
UL1RR024975	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Oct 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Dec 2029Estimated

Completion Date

Dec 2029Estimated

First Submitted Date

Dec 22, 2007

First Submission Date that Met QC Criteria

Dec 22, 2007

First Posted Date

Dec 27, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 3, 2025

Last Update Posted Date

Oct 8, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Satish R. Raj, Assistant Professor of Medicine & Cardiology, Vanderbilt University Medical CenterSponsor-Investigator

Lead Sponsor

Satish R. RajOTHER

Collaborators

Name	Class
National Center for Research Resources (NCRR)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	water ingestion (16 fl oz within 3 minutes)	Dietary Supplement: water

Interventions

Name	Type	Description	Arm Group Labels	Other Names
water	Dietary Supplement	water 500 ml x 1	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change in total vascular resistance	TPR measured by Modelflow	40 min (before to 30 min after water ingestion

Secondary Outcomes

Measure	Description	Time Frame
blood pressure	peak BP over 40 min	40 min
heart rate	HR at time of peak BP over 40 min	40 min

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Satish R Raj, MD, MSCI	Vanderbilt University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tennessee Valley Health Systems (Nashville VA)		Nashville	Tennessee	37212	United States
Vanderbilt University

Intervention Browse Module

MeSH Terms

ID	Term
D014867	Water

Ancestor Terms

ID	Term
D006878	Hydroxides
D000468	Alkalies
D007287	Inorganic Chemicals
D000838	Anions
D007477

Browse Leaves

Not provided

Browse Branches

Not provided