Heart Failure and Peritoneal Ultrafiltration

Congestive Heart Failure Clinical Trial

Official title:

Treatment-Resistant Heart Failure (HF) and Peritoneal Ultrafiltration (PUF): A Randomized Prospective Trial of Standard Care Versus Standard Care With Peritoneal Ultrafiltration in Patients With Treatment-Resistant Severe Heart Failure

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00368641
• Other study ID #: 25885
• Status: Terminated
• Phase: Phase 2
• First received: August 23, 2006
• Last updated: April 30, 2009
• Start date: August 2006
• Est. completion date: April 2008

Study information

• Verified date: April 2009
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaAustralia: Department of Health and Ageing Therapeutic Goods AdministrationBelgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
• Study type: Interventional

Clinical Trial Summary

The objective of the study is to determine if the addition of peritoneal ultrafiltration to standard therapy in treatment-resistant severe heart failure patients will improve fluid balance and functional capacity such that they will spend less time in the hospital and have an improved ambulatory quality of life in comparison to patients who remain on standard therapy alone.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults with congestive heart failure (CHF) who remain fluid overloaded despite standard treatment.

Exclusion Criteria:

• Patients who have reversible CHF or have diseases or conditions that would contraindicate the use of peritoneal dialysis.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Drug:
• Extraneal
Periotneal Dialysis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-Cause Hospitalization (Unadjusted)		6 to 24 months	Yes