Back to resultsWater Immersion in Right-Sided Heart Failure: A Pilot Study
Primary Purpose
Right Sided Cardiac Failure
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Water immersion
Sponsored by
About this trial
This is an interventional treatment trial for Right Sided Cardiac Failure
Eligibility Criteria
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.
Sites / Locations
- University of Maryland
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
1
2
Arm Description
Patients will have water immersion on first day and sitting in a tub without water on the second day.
Patients will sit in a tub without water on the first day and have water immersion on the second day.
Outcomes
Primary Outcome Measures
Diuresis
Secondary Outcome Measures
Neurohormonal activation
Natriuresis
Full Information
NCT ID
NCT00654264
First Posted
April 1, 2008
Last Updated
February 23, 2022
Sponsor
University of Maryland, Baltimore
1. Study Identification
Unique Protocol Identification Number
NCT00654264
Brief Title
Water Immersion in Right-Sided Heart Failure: A Pilot Study
Official Title
Water Immersion in Right-Sided Heart Failure: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Right Sided Cardiac Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
Patients will have water immersion on first day and sitting in a tub without water on the second day.
Arm Title
2
Arm Type
Other
Arm Description
Patients will sit in a tub without water on the first day and have water immersion on the second day.
Intervention Type
Procedure
Intervention Name(s)
Water immersion
Intervention Description
Subjects will sit in tub for four hours.
Primary Outcome Measure Information:
Title
Diuresis
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
Neurohormonal activation
Time Frame
4 hours
Title
Natriuresis
Time Frame
4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Gottlieb, MD
Organizational Affiliation
University of Maryland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Water Immersion in Right-Sided Heart Failure: A Pilot Study
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