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

Sponsor

University of Maryland, Baltimore (Other)

Overall Status

Completed

CT.gov ID

NCT00654264

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Right Sided Cardiac Failure	Procedure: Water immersion	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

13 participants

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

Study Start Date :

Dec 1, 2007

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.
Other: 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.

Arm

Intervention/Treatment

Other: 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.

Other: 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.

Outcome Measures

Primary Outcome Measures

Diuresis [4 hours]

Secondary Outcome Measures

Neurohormonal activation [4 hours]
Natriuresis [4 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of Maryland	Baltimore	Maryland	United States	21201

Sponsors and Collaborators

University of Maryland, Baltimore

Investigators

Principal Investigator: Stephen Gottlieb, MD, University of Maryland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Stephen Gottlieb, Professor, University of Maryland, Baltimore

ClinicalTrials.gov Identifier:

NCT00654264

Other Study ID Numbers:

H-29283

First Posted:

Apr 7, 2008

Last Update Posted:

Mar 9, 2022

Last Verified:

Feb 1, 2022

Additional relevant MeSH terms:

Heart Failure

Dextrocardia

Study Results

No Results Posted as of Mar 9, 2022