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

Vantive Health LLC0 sites12 target enrollmentAugust 1, 2006

ConditionsCongestive Heart Failure

InterventionsExtraneal

DrugsExtraneal

Overview

Phase: Phase 2
Intervention: Extraneal
Conditions: Congestive Heart Failure
Sponsor: Vantive Health LLC
Enrollment: 12
Primary Endpoint: All-cause Hospitalization (Unadjusted)
Status: Terminated
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

August 1, 2006

End Date

April 1, 2008

Last Updated

9 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Vantive Health LLC

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

Intervention

peritoneal dialysis

Intervention: Extraneal

Outcomes

Primary Outcomes

All-cause Hospitalization (Unadjusted)

Time Frame: 6 to 24 months

All-cause hospitalization was defined as (1) hospitalization for any cause of any duration or (2)any ER visit or any clinic visit specifically for congestive heart failure requiring intravenous administration of an inotrope, vasodilator or diuretic.