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

Phase 4

Completed

• Conditions: Right Sided Cardiac Failure
• Interventions: Procedure: Water immersion

• Registration Number: NCT00654264
• Lead Sponsor: University of Maryland, Baltimore

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 Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-04-01
• Study First Submitted QC: 2008-04-04
• Study First Posted: 2008-04-07
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-23
• Last Update Posted: 2022-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Water immersion	Patients will have water immersion on first day and sitting in a tub without water on the second day.
2	Water immersion	Patients will sit in a tub without water on the first day and have water immersion on the second day.

Primary Outcome Measures

Name	Time	Method
Diuresis	4 hours

Secondary Outcome Measures

Name	Time	Method
Neurohormonal activation	4 hours
Natriuresis	4 hours

Trial Locations

Locations (1)

University of Maryland; 🇺🇸 Baltimore, Maryland, United States