NCT00654264

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 7, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

March 9, 2022

Status Verified

February 1, 2022

Enrollment Period

2 years

First QC Date

April 1, 2008

Last Update Submit

February 23, 2022

Conditions

Right Sided Cardiac Failure

Outcome Measures

Primary Outcomes (1)

  • Diuresis

    4 hours

Secondary Outcomes (2)

  • Neurohormonal activation

    4 hours

  • Natriuresis

    4 hours

Study Arms (2)

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

Water immersionPROCEDURE

Subjects will sit in tub for four hours.

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Study Officials

  • Stephen Gottlieb, MD

    University of Maryland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 1, 2008

First Posted

April 7, 2008

Study Start

December 1, 2007

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

March 9, 2022

Record last verified: 2022-02

Locations

US(1)