Heart Failure and Peritoneal Ultrafiltration

Phase 2TerminatedNCT00368641

Vantive Health LLC12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Congestive Heart Failure

Interventions

ExtranealDRUG

Periotneal Dialysis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (11)

Unnamed facility

San Jose, California, United States

Unnamed facility

Torrance, California, United States

Unnamed facility

Denver, Colorado, United States

Unnamed facility

Evanston, Illinois, United States

Outcomes

Primary Outcomes

All-cause Hospitalization (Unadjusted)

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.

Time frame: 6 to 24 months

Data from ClinicalTrials.gov

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