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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00654264
First Posted: April 7, 2008
Last Update Posted: October 28, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Steve Gottlieb, University of Maryland
  Purpose
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.

Condition Intervention Phase
Right Sided Cardiac Failure Procedure: Water immersion Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Water Immersion in Right-Sided Heart Failure: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Steve Gottlieb, University of Maryland:

Primary Outcome Measures:
  • Diuresis [ Time Frame: 4 hours ]

Secondary Outcome Measures:
  • Neurohormonal activation [ Time Frame: 4 hours ]
  • Natriuresis [ Time Frame: 4 hours ]

Estimated Enrollment: 13
Study Start Date: December 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Patients will have water immersion on first day and sitting in a tub without water on the second day.
Procedure: Water immersion
Subjects will sit in tub for four hours.
2
Patients will sit in a tub without water on the first day and have water immersion on the second day.
Procedure: Water immersion
Subjects will sit in tub for four hours.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00654264


Locations
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Stephen Gottlieb, MD University of Maryland
  More Information

Responsible Party: Steve Gottlieb, Professor, University of Maryland
ClinicalTrials.gov Identifier: NCT00654264     History of Changes
Other Study ID Numbers: H-29283
First Submitted: April 1, 2008
First Posted: April 7, 2008
Last Update Posted: October 28, 2011
Last Verified: October 2011

Additional relevant MeSH terms:
Heart Failure
Dextrocardia
Heart Diseases
Cardiovascular Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities
Situs Inversus