Water Immersion in Right-Sided Heart Failure: A Pilot Study | NCT00654264

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

NCT00654264

Sponsor

University of Maryland, Baltimore

Status

Completed

Last Update Posted

Mar 9, 2022Actual

Enrollment

13Estimated

Phase

Phase 4

Conditions

Right Sided Cardiac Failure

Interventions

Water immersion

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2007

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Apr 1, 2008

First Submission Date that Met QC Criteria

Apr 4, 2008

First Posted Date

Apr 7, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 23, 2022

Last Update Posted Date

Mar 9, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

13Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Other	Patients will have water immersion on first day and sitting in a tub without water on the second day.	Procedure: Water immersion
2	Other	Patients will sit in a tub without water on the first day and have water immersion on the second day.	Procedure: Water immersion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Water immersion	Procedure	Subjects will sit in tub for four hours.	1 2

Measure	Description	Time Frame
Diuresis		4 hours

Measure	Description	Time Frame
Neurohormonal activation		4 hours
Natriuresis		4 hours

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stephen Gottlieb, MD	University of Maryland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Maryland		Baltimore	Maryland	21201	United States