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

Sponsor:	University of Maryland
Information provided by (Responsible Party):	Steve Gottlieb, University of Maryland
ClinicalTrials.gov Identifier:	NCT00654264

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 IV

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:

MedlinePlus related topics: Heart Failure

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 February 13, 2012