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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Steve Gottlieb, University of Maryland
ClinicalTrials.gov Identifier:
NCT00654264
First received: April 1, 2008
Last updated: October 27, 2011
Last verified: October 2011

April 1, 2008
October 27, 2011
December 2007
December 2009   (final data collection date for primary outcome measure)
Diuresis [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00654264 on ClinicalTrials.gov Archive Site
  • Neurohormonal activation [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
  • Natriuresis [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Water Immersion in Right-Sided Heart Failure: A Pilot Study
Water Immersion in Right-Sided Heart Failure: A Pilot Study

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Right Sided Cardiac Failure
Procedure: Water immersion
Subjects will sit in tub for four hours.
  • 1
    Patients will have water immersion on first day and sitting in a tub without water on the second day.
    Intervention: Procedure: Water immersion
  • 2
    Patients will sit in a tub without water on the first day and have water immersion on the second day.
    Intervention: Procedure: Water immersion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
December 2009
December 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00654264
H-29283
Yes
Steve Gottlieb, University of Maryland
University of Maryland
Not Provided
Principal Investigator: Stephen Gottlieb, MD University of Maryland
University of Maryland
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP