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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 40 min (before to 30 min after water ingestion
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have had a heart transplant and am scheduled for a heart catheterization.
Select...
I am over 18 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 40 min (before to 30 min after water ingestion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~40 min (before to 30 min after water ingestion
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
change in total vascular resistance
Secondary outcome measures
blood pressure
heart rate
Norepinephrine
Side effects data
From 2007 Phase 3 trial • 67 Patients • NCT0102100724%
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
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
537 Previous Clinical Trials
316,976 Total Patients Enrolled
Satish R. RajLead Sponsor
6 Previous Clinical Trials
490 Total Patients Enrolled
Satish R Raj, MD, MSCIPrincipal InvestigatorVanderbilt University Medical Center
4 Previous Clinical Trials
247 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a heart transplant and am scheduled for a heart catheterization.I am over 18 years old.I have severe leakage in my heart's tricuspid valve.I have a serious health condition like advanced kidney disease.I cannot safely drink 500 ml of water.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies still available for participants in this research?
"According to clinicaltrials.gov, the recruitment of patients for this study has been completed with the last edit on September 12th 2022. However, there are numerous other research studies currently recruiting participants - 105 in total at present."
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