Congestive Heart FailurePhase 2NCT00368641
Heart Failure and Peritoneal Ultrafiltration
A Phase 2 study testing Extraneal in people with Congestive Heart Failure, run by Vantive Health LLC at 11 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- Extraneal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 11 sitesin 4 countries
- Study dates
- Aug 2006to Apr 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with congestive heart failure (CHF) who remain fluid overloaded despite standard treatment.
Who cannot join
- Patients who have reversible CHF or have diseases or conditions that would contraindicate the use of peritoneal dialysis.
Trial locations and contacts
11 sites in 4 countries.
11 sites in 4 countries
United States5 sites
Study site
Denver, Colorado
Study site
Evanston, Illinois
Study site
San Jose, California
Study site
Torrance, California
Study site
Winston-Salem, North Carolina
About this study
Official title: 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
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.
- Conditions
- Congestive Heart Failure
- Being tested
- Extraneal
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExtranealDrug
Periotneal Dialysis
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | peritoneal dialysis Receives: Drug: Extraneal |
| Standard of Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2006 (estimated)
- Study startAug 2006
- Primary completionApr 2008
- Study completionApr 2008
Why it stopped: Enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vantive Health LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baxter Healthcare Corporation (Former Sponsor)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00368641
- Sponsor's protocol ID
- 25885
- Status last verified
- Jul 2025
- First submitted
- 23 Aug 2006
- Last updated
- 15 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00368641
- Acronym / sponsor ID
- 25885
- Conditions
- Congestive Heart Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Vantive Health LLCIndustry (pharma, biotech, devices)
- Collaborators
- Baxter Healthcare Corporation (Former Sponsor)
- Study start
- Aug 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 25 Aug 2006 (estimated)
- Results
- Posted 17 Jun 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Extranealperitoneal dialysis |
| Standard of Care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults with congestive heart failure (CHF) who remain fluid overloaded despite standard treatment.
Key exclusion criteria (1 listed)
- Patients who have reversible CHF or have diseases or conditions that would contraindicate the use of peritoneal dialysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExtranealPeriotneal Dialysis | Drug | Intervention |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Extraneal in people with Congestive Heart Failure, run by Vantive Health LLC at 11 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Belgium, Canada, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jun 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause Hospitalization (Unadjusted) (time frame: 6 to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.