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

February 23, 2022 updated by: Stephen Gottlieb, University of Maryland, Baltimore
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

13

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diuresis
Time Frame: 4 hours
4 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Neurohormonal activation
Time Frame: 4 hours
4 hours
Natriuresis
Time Frame: 4 hours
4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Investigators

  • Principal Investigator: Stephen Gottlieb, MD, University of Maryland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

April 1, 2008

First Submitted That Met QC Criteria

April 4, 2008

First Posted (Estimate)

April 7, 2008

Study Record Updates

Last Update Posted (Actual)

March 9, 2022

Last Update Submitted That Met QC Criteria

February 23, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-29283

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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