NCT00368641

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2006

Geographic Reach
4 countries

11 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

June 17, 2009

Completed
Last Updated

July 15, 2025

Status Verified

July 1, 2025

Enrollment Period

1.7 years

First QC Date

August 23, 2006

Results QC Date

April 30, 2009

Last Update Submit

July 3, 2025

Conditions

Congestive Heart Failure

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 to 24 months

Study Arms (2)

Intervention

EXPERIMENTAL

peritoneal dialysis

Drug: Extraneal

Standard of Care

NO INTERVENTION

Interventions

ExtranealDRUG

Periotneal Dialysis

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults with congestive heart failure (CHF) who remain fluid overloaded despite standard treatment.

You may not qualify if:

  • Patients who have reversible CHF or have diseases or conditions that would contraindicate the use of peritoneal dialysis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Unknown Facility

San Jose, California, United States

Location

Unknown Facility

Torrance, California, United States

Location

Unknown Facility

Denver, Colorado, United States

Location

Unknown Facility

Evanston, Illinois, United States

Location

Unknown Facility

Winston-Salem, North Carolina, United States

Location

Unknown Facility

Melbourne, Victoria, Australia

Location

Unknown Facility

Leuven, Belgium

Location

Unknown Facility

Liège, Belgium

Location

Unknown Facility

Roeselare, Belgium

Location

Unknown Facility

Toronto, Ontario, Canada

Location

Unknown Facility

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Icodextrin

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

GlucansBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydrates

Limitations and Caveats

The number of subjects enrolled \& duration of therapy were insufficient to complete the planned efficacy analyses \& to draw any conclusion regarding all-cause hospitalization rates in both intervention and standard therapy arms.

Results Point of Contact

Title
Global CORP Clinical Trials Disclosure
Organization
Vantive
Global.CORP.ClinicalTrialsDisclosure@vantive.com
+1 2249484283

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2006

First Posted

August 25, 2006

Study Start

August 1, 2006

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

July 15, 2025

Results First Posted

June 17, 2009

Record last verified: 2025-07

Locations

CA(2)BE(3)AU(1)US(5)