Heart Failure and Peritoneal Ultrafiltration

Phase 2

Terminated

• Conditions: Congestive Heart Failure
• Interventions: Drug: Extraneal

• Registration Number: NCT00368641
• Lead Sponsor: Vantive Health LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2006-08-23
• Study First Submitted QC: 2006-08-23
• Study First Posted: 2006-08-25
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Results First Submitted: 2009-04-30
• Results First Submitted QC: 2009-04-30
• Results First Posted: 2009-06-17
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-03-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Extraneal	peritoneal dialysis

Primary Outcome Measures

Name	Time	Method
All-cause Hospitalization (Unadjusted)	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.