Congestive Heart Failure
Conditions
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.
Interventions
DRUGExtraneal
Periotneal Dialysis
Sponsors
Baxter Healthcare Corporation (Former Sponsor)
Vantive Health LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Australia, Belgium, Canada, United States
Participant flow
Recruitment details
12 sites were active to enroll subjects from March 2, 2007 through February 29, 2008
Pre-assignment details
Subjects were required to meet all inclusion and no exclusion criteria for study participation
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group Addition of peritoneal ultrafiltration | 6 |
| Standard Therapy Standard therapy for CHF | 6 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 |
| Overall Study | Death | 1 | 0 |
| Overall Study | Sponsor decision to terminate study | 2 | 5 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Intervention Group | Standard Therapy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 4 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 2 Participants | 2 Participants |
| Age, Continuous | 77.8 years STANDARD_DEVIATION 4.1 | 70.7 years STANDARD_DEVIATION 13.1 | 74.3 years STANDARD_DEVIATION 10 |
| Region of Enrollment Belgium | 1 participants | 1 participants | 2.0 participants |
| Region of Enrollment Canada | 3 participants | 3 participants | 6.0 participants |
| Region of Enrollment United States | 2 participants | 2 participants | 4.0 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / — | 6 / — |
| serious Total, serious adverse events | 6 / — | 4 / — |
Outcome results
Primary
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
Population: intent to treat population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Group | All-cause Hospitalization (Unadjusted) | 5.33 hospitalizations per year |
| Standard Therapy | All-cause Hospitalization (Unadjusted) | 1.69 hospitalizations per year |