Blood PressureNCT00581321
Oral Water Ingestion in Heart Transplant Patients
A study testing water in people with Blood Pressure and Cardiac Transplantation, run by Satish R. Raj at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure, Cardiac Transplantation
- What is being tested?
- water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2006to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- s/p cardiac transplantation scheduled for clinical right heart catheterization
- age > 18 years
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Tennessee Valley Health Systems (Nashville VA)
Nashville, Tennessee, 37212
Vanderbilt University
Nashville, Tennessee, 37232
About this study
Official title: Acute Hemodynamic Effects of Oral Water in a Stable Cardiac Transplant Population
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.
Read the 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.
- Conditions
- Blood Pressure, Cardiac Transplantation
- Being tested
- water
- Keywords
- water, blood pressure, vascular resistance, cardiac transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
waterDietary supplement
water 500 ml x 1
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | water ingestion (16 fl oz within 3 minutes) Receives: Dietary Supplement: water |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in total vascular resistance
TPR measured by Modelflow
Measured: 40 min (before to 30 min after water ingestion
Secondary outcomes (3)
blood pressure
peak BP over 40 min
Measured: 40 min
heart rate
HR at time of peak BP over 40 min
Measured: 40 min
plasma norepinephrine
plasma norepinephrine drawn 40 min post ingestion
Measured: 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2007 (estimated)
- Study startJan 2006
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Satish R. Raj
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Responsible party
- Sponsor-investigator, Satish R. Raj, Vanderbilt University Medical Center
- Investigators
- Satish R Raj, MD, MSCI, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00581321
- Sponsor's protocol ID
- 050811
- Other IDs
- UL1RR024975
- Status last verified
- Oct 2026
- First submitted
- 22 Dec 2007
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Hemodynamic Effects of Oral Water in a Stable Cardiac Transplant Population
- ClinicalTrials.gov ID
- NCT00581321
- Acronym / sponsor ID
- 050811
- Conditions
- Blood Pressure, Cardiac Transplantation
- Keywords
- water, blood pressure, vascular resistance, cardiac transplantation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Satish R. RajUniversity, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Study start
- Jan 2006
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 27 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: waterwater ingestion (16 fl oz within 3 minutes) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- s/p cardiac transplantation scheduled for clinical right heart catheterization
- age > 18 years
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| waterwater 500 ml x 1 | Dietary supplement | 1 |
Primary outcome
change in total vascular resistance
Time frame: 40 min (before to 30 min after water ingestion
TPR measured by Modelflow
3 secondary outcomes
blood pressure
Time frame: 40 min
heart rate
Time frame: 40 min
plasma norepinephrine
Time frame: 40 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
Related trials for Blood Pressure
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
RecruitingPhase 3
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
Chronic Kidney Disease and Hypertension
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingPhase 4
Hematological Safety of Dipyrone Versus Paracetamol After Dental Extractions
Hematologic Test, Agranulocytosis
Not yet recruiting
Acute Effects of Mat Pilates on Blood Pressure Response to Mental Stress in Higher Education Teachers
Behavior
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Satish R Raj, MD, MSCI principal investigator
Vanderbilt University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing water in people with Blood Pressure and Cardiac Transplantation, run by Satish R. Raj at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in total vascular resistance (time frame: 40 min (before to 30 min after water ingestion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.