Heart FailurePhase 4NCT00288587
Extracorporeal Ultrafiltration (UF) vs. Usual and Customary Care for Patients With Severe Heart Failure (HF)
A Phase 4 study testing IV loop diuretic and NxStage System One in people with Heart Failure and CHF, run by NxStage Medical at 1 site in United States.
Trial summary
The purpose of this study is to assess the ability of Ultrafiltration to influence the rate of hemodynamic improvement, as measured by the decline in the pulmonary artery occlusion pressure, in patients with NYHA class III/IV Heart Failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, CHF
- What is being tested?
- IV loop diuretic and NxStage System One
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Jan 2009
- Phase
- Phase 4
- 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
- Admitted to Heart Failure Unit (H-22) with NYHA class III/IV HF and pulmonary artery catheter in situ
- Left ventricular ejection fraction <40%
- Mean Pulmonary Artery Occlusion Pressure ≥20 mm Hg
- Able to give informed consent
Who cannot join
- Currently on renal replacement therapy or determined to need renal replacement therapy at the time of enrollment
- Estimated glomerular filtration rate (GFR) <15 mL/min
- Systolic blood pressure (SBP) <80 mm Hg
- Acute coronary syndrome
- Hematocrit >50%
- Malignancy other than prostrate or skin
Show all 15Show fewer
- Chronic edematous states other than HF, including nephritic syndrome and cirrhosis
- Chronic inflammatory or infectious condition
- Pregnancy
- Previous enrollment in this study
- Expectation of need for heart transplantation or cardiac assist device within one week
- Pulmonary failure requiring intubation and mechanical ventilation
- Known or suspected hypersensitivity to dialysis membranes
- Severe aortic stenosis or regurgitation
- Severe mitral stenosis
Trial locations and contacts
1 site in 1 country.
United States1 site
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
About this study
Official title: CP0007: Extracorporeal Ultrafiltration (UF) vs. Usual and Customary Care for Patients With Severe Heart Failure (HF)
The purpose of this study is to assess the ability of Ultrafiltration to influence the rate of hemodynamic improvement, as measured by the decline in the pulmonary artery occlusion pressure, in patients with NYHA class III/IV Heart Failure.
Read the detailed description
This study will be preformed in a specialized heart failure unit at the Cleveland Clinic Foundation (CCF) and will include both the UF-treated group and a control group receiving usual and customary care. Patients will be stratified according to renal function at the time of admission. Therapies will be guided by specific hemodynamic criteria routinely used at the study institution.
- Conditions
- Heart Failure, CHF
- Being tested
- IV loop diuretic, NxStage System One
- Keywords
- Heart Failure, Congestive Heart Failure, CHF
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV loop diureticDrug
Use of conventional diuretic therapy upon hospital admission for treatment of decompensated heart failure.
NxStage System OneDevice
Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
| Study group | Role | What they receive |
|---|---|---|
| Ultrafiltration | Active comparator | Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure. Receives: Device: NxStage System One |
| Usual & Customary | Active comparator | Patients treated with conventional diuretic therapy upon hospital admission for treatment of decompensated heart failure. Receives: Drug: IV loop diuretic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Required for the Pulmonary Artery Occlusion Pressure (PAOP) to be Maintained at a Value of Less Than or Equal to 18 mmHg for at Least Four Consecutive Hours (+/- 30 Minutes) During the Intervention Period.
Measured: 4 consecutive hours (+/- 30 minutes)
Secondary outcomes (4)
Time to Discharge From the Heart Failure (HF) Unit, and Time to Discharge From the Hospital.
Measured: Time from admission to endpoint achievement
Total Volume Removal During the Intervention Period
Measured: Intervention start to end.
Volume Removal Rate.
Hours of therapy required to remove 1 liter of fluid normalized to body weight.
Measured: Intervention start to end.
Composite Endpoint of Hospital Readmissions, Emergency Department Visits, and Deaths
Number of patients experiencing at least one of the composite endpoint measures within 90 days of hospital discharge.
Measured: Hospital discharge to 90 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2006 (estimated)
- Study startOct 2003
- Primary completionSep 2008
- Study completionJan 2009
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- NxStage Medical
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alan Hull, MD, Study director, NxStage Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00288587
- Sponsor's protocol ID
- CP0007
- Status last verified
- May 2012
- First submitted
- 6 Feb 2006
- Last updated
- 19 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Hanna MA, Tang WH, Teo BW, O'Neill JO, Weinstein DM, Lau SM, Van Lente F, Starling RC, Paganini EP, Taylor DO. Extracorporeal ultrafiltration vs. conventional diuretic therapy in advanced decompensated heart failure. Congest Heart Fail. 2012 Jan-Feb;18(1):54-63. doi: 10.1111/j.1751-7133.2011.00231.x. Epub 2011 Jul 20.
PubMed 22277179
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CP0007: Extracorporeal Ultrafiltration (UF) vs. Usual and Customary Care for Patients With Severe Heart Failure (HF)
- ClinicalTrials.gov ID
- NCT00288587
- Acronym / sponsor ID
- CP0007
- Conditions
- Heart Failure, CHF
- Keywords
- Heart Failure, Congestive Heart Failure, CHF
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- NxStage MedicalUniversity, hospital or other
- Study start
- Oct 2003
- Primary completion
- Sep 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 8 Feb 2006 (estimated)
- Results
- Posted 19 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the ability of Ultrafiltration to influence the rate of hemodynamic improvement, as measured by the decline in the pulmonary artery occlusion pressure, in patients with NYHA class III/IV Heart Failure.
Detailed description
This study will be preformed in a specialized heart failure unit at the Cleveland Clinic Foundation (CCF) and will include both the UF-treated group and a control group receiving usual and customary care. Patients will be stratified according to renal function at the time of admission. Therapies will be guided by specific hemodynamic criteria routinely used at the study institution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrafiltration | Active comparator | Device: NxStage System OnePatients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure. |
| Usual & Customary | Active comparator | Drug: IV loop diureticPatients treated with conventional diuretic therapy upon hospital admission for treatment of decompensated heart failure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Admitted to Heart Failure Unit (H-22) with NYHA class III/IV HF and pulmonary artery catheter in situ
- Left ventricular ejection fraction <40%
- Mean Pulmonary Artery Occlusion Pressure ≥20 mm Hg
- Able to give informed consent
Key exclusion criteria (15 listed)
- Currently on renal replacement therapy or determined to need renal replacement therapy at the time of enrollment
- Estimated glomerular filtration rate (GFR) <15 mL/min
- Systolic blood pressure (SBP) <80 mm Hg
- Acute coronary syndrome
- Hematocrit >50%
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 |
|---|---|---|
| IV loop diureticUse of conventional diuretic therapy upon hospital admission for treatment of decompensated heart failure. | Drug | Usual & Customary |
| NxStage System OnePatients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure. | Device | Ultrafiltration |
Primary outcome
Time Required for the Pulmonary Artery Occlusion Pressure (PAOP) to be Maintained at a Value of Less Than or Equal to 18 mmHg for at Least Four Consecutive Hours (+/- 30 Minutes) During the Intervention Period.
Time frame: 4 consecutive hours (+/- 30 minutes)
4 secondary outcomes
Time to Discharge From the Heart Failure (HF) Unit, and Time to Discharge From the Hospital.
Time frame: Time from admission to endpoint achievement
Total Volume Removal During the Intervention Period
Time frame: Intervention start to end.
Volume Removal Rate.
Time frame: Intervention start to end.
Composite Endpoint of Hospital Readmissions, Emergency Department Visits, and Deaths
Time frame: Hospital discharge to 90 days after discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22277179Hanna MA, Tang WH, Teo BW, O'Neill JO, Weinstein DM, Lau SM, Van Lente F, Starling RC, Paganini EP, Taylor DO. Extracorporeal ultrafiltration vs. conventional diuretic therapy in advanced decompensated heart failure. Congest Heart Fail. 2012 Jan-Feb;18(1):54-63. doi: 10.1111/j.1751-7133.2011.00231.x. Epub 2011 Jul 20.
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
Alan Hull, MD study director
NxStage Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing IV loop diuretic and NxStage System One in people with Heart Failure and CHF, run by NxStage Medical at 1 site in United States.
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 4 inclusion and 15 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: finished, as of the sponsor's last update on 19 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 19 Jun 2012). 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?
Time Required for the Pulmonary Artery Occlusion Pressure (PAOP) to be Maintained at a Value of Less Than or Equal to 18 mmHg for at Least Four Consecutive Hours (+/- 30 Minutes) During the Intervention Period. (time frame: 4 consecutive hours (+/- 30 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00288587, which also lists 1 linked publication.
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 19 Jun 2012.