Heart Failure and Peritoneal Ultrafiltration

Vantive Health LLC

Status and phase: Terminated; Phase 2

Conditions: Congestive Heart Failure

Treatments: Drug: Extraneal

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT00368641

25885

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Intervention

Experimental group

Description:

peritoneal dialysis

Treatment:

Drug: Extraneal

Standard of Care

No Intervention group