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Water Immersion in Right-Sided Heart Failure: A Pilot Study

This study is currently recruiting participants.
Study NCT00654264.   Last updated on October 7, 2008.   Information provided by University of Maryland

This Tabular View shows the required WHO registration data elements as marked by †

Descriptive Information Fields
Brief Title † Water Immersion in Right-Sided Heart Failure: A Pilot Study
Official Title † Water Immersion in Right-Sided Heart Failure: A Pilot Study
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.
Study Phase Phase IV
Study Type † Interventional
Study Design † Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Primary Outcome Measure † Diuresis [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
Secondary Outcome Measure † Neurohormonal activation [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
Natriuresis [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
Condition † Right Sided Cardiac Failure
Intervention † Procedure: Water immersion
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status † Recruiting
Enrollment † 13
Start Date † December 2007
Completion Date December 2009
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.
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Stephen Gottlieb, MD     4103288788     sgottlie@medicine.umaryland.edu    
Location Countries † United States
Administrative Information Fields
NCT ID † NCT00654264
Organization ID H-29283
Secondary IDs ††
Study Sponsor † University of Maryland
Collaborators ††
Investigators †
Principal Investigator:     Stephen Gottlieb, MD     University of Maryland    
Information Provided By University of Maryland
Verification Date October 2008
First Received Date † April 1, 2008
Last Updated Date October 7, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.

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