Oral Water Ingestion in Heart Transplant Patients

NCT ID: NCT00581321

Last Updated: 2025-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2029-12-31

Brief Summary

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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

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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.

Conditions

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Blood Pressure Cardiac Transplantation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

water ingestion (16 fl oz within 3 minutes)

Group Type EXPERIMENTAL

water

Intervention Type DIETARY_SUPPLEMENT

water 500 ml x 1

Interventions

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water

water 500 ml x 1

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Research Resources (NCRR)

NIH

Sponsor Role collaborator

Satish R. Raj

OTHER

Sponsor Role lead

Responsible Party

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Satish R. Raj

Assistant Professor of Medicine & Cardiology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Satish R Raj, MD, MSCI

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

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Tennessee Valley Health Systems (Nashville VA)

Nashville, Tennessee, United States

Site Status

Vanderbilt University

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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UL1RR024975

Identifier Type: NIH

Identifier Source: secondary_id

View Link

050811

Identifier Type: -

Identifier Source: org_study_id

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