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NCT Number: NCT00581321

Oral Water Ingestion in Heart Transplant Patients

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Blood Pressure Cardiac Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tennessee Valley Health Systems (Nashville VA), Nashville, Tennessee, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Water

Dietary Supplement

water 500 ml x 1

Primary outcomes

  1. change in total vascular resistance

    Time frame: 40 min (before to 30 min after water ingestion

    TPR measured by Modelflow

Secondary outcomes

  1. blood pressure

    Time frame: 40 min

    peak BP over 40 min

  2. heart rate

    Time frame: 40 min

    HR at time of peak BP over 40 min

  3. plasma norepinephrine

    Time frame: 40 minutes

    plasma norepinephrine drawn 40 min post ingestion

Sponsors and collaborators

Lead sponsor

Satish R. Raj

Other

Collaborators

  • National Center for Research Resources (NCRR)

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2029
Study completion
2029
First posted
Dec 27, 2007
Registry last updated
Oct 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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