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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
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Water Immersion in Right-Sided Heart Failure: A Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Diuresis [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neurohormonal activation [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
  • Natriuresis [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Steve Gottlieb, Professor, University of Maryland
ClinicalTrials.gov Identifier: NCT00654264     History of Changes
Other Study ID Numbers: H-29283
Study First Received: April 1, 2008
Last Updated: October 27, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 16, 2013