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Water Ingestion for Heart Transplant Patients

N/A
Waitlist Available
Led By Satish R Raj, MD, MSCI
Research Sponsored by Satish R. Raj
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients who have undergone cardiac transplantation and are scheduled for clinical right heart catheterization
Patients aged over 18 years
Must not have
Presence of significant tricuspid regurgitation
Inability to safely swallow 500 ml of water
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether water ingestion increases systemic vascular resistance.

Who is the study for?
This trial is for heart transplant patients over 18 years old who are scheduled for a clinical right heart catheterization. It's not suitable for those with significant tricuspid regurgitation, difficulty swallowing large amounts of water, or severe kidney disease where drinking water could be harmful.
What is being tested?
The study is examining the effects of drinking 16 fl oz of water on blood vessel resistance in heart transplant recipients. The goal is to see if consuming this amount of water will increase the resistance in systemic blood vessels.
What are the potential side effects?
Since the intervention involves only ingesting water, no direct side effects are expected from the treatment itself; however, participants with certain health conditions were excluded to prevent potential harm.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had a heart transplant and am scheduled for a heart catheterization.
Select...
I am over 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have severe leakage in my heart's tricuspid valve.
Select...
I cannot safely drink 500 ml of water.
Select...
I have a serious health condition like advanced kidney disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2007 Phase 3 trial • 67 Patients • NCT01021007
24%
discomfort in mouth or body
9%
slight swelling or inflammation of the gums
3%
Tooth staining
100%
80%
60%
40%
20%
0%
Study treatment Arm
Negative Control Rinse
Iocide Mouthrinse

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment1 Intervention
water ingestion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
water
2006
Completed Phase 4
~8920

Find a Location

Who is running the clinical trial?

National Center for Research Resources (NCRR)NIH
539 Previous Clinical Trials
317,062 Total Patients Enrolled
Satish R. RajLead Sponsor
6 Previous Clinical Trials
650 Total Patients Enrolled
Satish R Raj, MD, MSCIPrincipal InvestigatorVanderbilt University Medical Center
4 Previous Clinical Trials
247 Total Patients Enrolled

Media Library

water Clinical Trial Eligibility Overview. Trial Name: NCT00581321 — N/A
water 2023 Treatment Timeline for Medical Study. Trial Name: NCT00581321 — N/A
Heart Transplant Research Study Groups: 1
Heart Transplant Clinical Trial 2023: water Highlights & Side Effects. Trial Name: NCT00581321 — N/A
~5 spots leftby Dec 2027
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