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

Tracking Information

First Received Date ^ICMJE

April 1, 2008

Last Updated Date

July 8, 2009

Start Date ^ICMJE

December 2007

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Diuresis [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00654264 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Neurohormonal activation [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
Natriuresis [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study

Condition ^ICMJE

Right Sided Cardiac Failure

Intervention ^ICMJE

Procedure: Water immersion

Study Arms / Comparison Groups

Other: Patients will have water immersion on first day and sitting in a tub without water on the second day.
Other: Patients will sit in a tub without water on the first day and have water immersion on the second day.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2009

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Contacts ^ICMJE

Contact: Stephen Gottlieb, MD

4103288788

sgottlie@medicine.umaryland.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00654264

Responsible Party

Stephen Gottlieb, University of MD

Study ID Numbers ^ICMJE

H-29283

Study Sponsor ^ICMJE

University of Maryland

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Stephen Gottlieb, MD

University of Maryland

Information Provided By

University of Maryland

Verification Date

July 2009

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