- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00654264
Water Immersion in Right-Sided Heart Failure: A Pilot Study
February 23, 2022 updated by: Stephen Gottlieb, University of Maryland, Baltimore
This is an unblinded pilot study comparing (against a randomized control day without water immersion) the diuretic and natriuretic effects of water immersion in patients with right heart failure.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Patients will be immersed in a tub for 3 hours (on one day) and neurohormones will be obtained before and after immersion.
Urine will be collected for quantification and evaluation of sodium concentration.
Study Type
Interventional
Enrollment (Anticipated)
13
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
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Baltimore, Maryland, United States, 21201
- University of Maryland
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients must have right sided failure secondary to right ventricular dysfunction, pulmonary hypertension, or tricuspid regurgitation
- Age greater than 18 years of age
- Right heart catheterization within the last year to rule out left-sided failure.
- Evidence of fluid overload as indicated by 2 or more of the following: 1.) 2+ or more pitting edema of the lower extremities, 2.) scrotal or penile edema, 3.) JVP greater than or equal to 10 cm, 4.) abdominal ascites
Exclusion Criteria:
- Pulmonary capillary wedge pressure above 16 mmHg or history of elevated left ventricular filling pressures.
- Serum creatinine > 2.0
- Current use of an angiotensin I converting enzyme inhibitor or angiotensin receptor blocker will preclude participation in the RAS neurohormone portion of the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 1
Patients will have water immersion on first day and sitting in a tub without water on the second day.
|
Subjects will sit in tub for four hours.
|
Other: 2
Patients will sit in a tub without water on the first day and have water immersion on the second day.
|
Subjects will sit in tub for four hours.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Diuresis
Time Frame: 4 hours
|
4 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Neurohormonal activation
Time Frame: 4 hours
|
4 hours
|
Natriuresis
Time Frame: 4 hours
|
4 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Stephen Gottlieb, MD, University of Maryland
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2007
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
April 1, 2008
First Submitted That Met QC Criteria
April 4, 2008
First Posted (Estimate)
April 7, 2008
Study Record Updates
Last Update Posted (Actual)
March 9, 2022
Last Update Submitted That Met QC Criteria
February 23, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-29283
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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