Heart Failure and Peritoneal Ultrafiltration

NCT ID: NCT00368641

Last Updated: 2025-07-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2008-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Congestive Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

peritoneal dialysis

Group Type EXPERIMENTAL

Extraneal

Intervention Type DRUG

Periotneal Dialysis

Standard of Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Extraneal

Periotneal Dialysis

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baxter Healthcare Corporation (Former Sponsor)

UNKNOWN

Sponsor Role collaborator

Vantive Health LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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San Jose, California, United States

Site Status

Torrance, California, United States

Site Status

Denver, Colorado, United States

Site Status

Evanston, Illinois, United States

Site Status

Winston-Salem, North Carolina, United States

Site Status

Melbourne, Victoria, Australia

Site Status

Leuven, , Belgium

Site Status

Liège, , Belgium

Site Status

Roeselare, , Belgium

Site Status

Toronto, Ontario, Canada

Site Status

Montreal, Quebec, Canada

Site Status

Countries

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United States Australia Belgium Canada

Other Identifiers

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25885

Identifier Type: -

Identifier Source: org_study_id

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