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

NCT ID: NCT00654264

Last Updated: 2022-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2009-12-31

Brief Summary

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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

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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.

Conditions

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Right Sided Cardiac Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

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

Group Type OTHER

Water immersion

Intervention Type PROCEDURE

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.

Group Type OTHER

Water immersion

Intervention Type PROCEDURE

Subjects will sit in tub for four hours.

Interventions

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Water immersion

Subjects will sit in tub for four hours.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Maryland, Baltimore

OTHER

Sponsor Role lead

Responsible Party

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Stephen Gottlieb

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stephen Gottlieb, MD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland

Locations

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University of Maryland

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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H-29283

Identifier Type: -

Identifier Source: org_study_id

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