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

University of Maryland Baltimore (UMB) logo

University of Maryland Baltimore (UMB)

Status and phase

Completed
Phase 4

Conditions

Right Sided Cardiac Failure

Treatments

Procedure: Water immersion

Study type

Interventional

Funder types

Other

Identifiers

NCT00654264
H-29283

Details and patient eligibility

About

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.

Full 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.

Enrollment

13 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

13 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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