CHF, Heart Failure
Conditions
Keywords
Heart Failure, Congestive Heart Failure, CHF
Brief 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.
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.
Interventions
DRUGIV loop diuretic
Use of conventional diuretic therapy upon hospital admission for treatment of decompensated heart failure.
DEVICENxStage System One
Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
Sponsors
NxStage Medical
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
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 4 consecutive hours (+/- 30 minutes) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Discharge From the Heart Failure (HF) Unit, and Time to Discharge From the Hospital. | Time from admission to endpoint achievement | — |
| Total Volume Removal During the Intervention Period | Intervention start to end. | — |
| Volume Removal Rate. | Intervention start to end. | Hours of therapy required to remove 1 liter of fluid normalized to body weight. |
| Composite Endpoint of Hospital Readmissions, Emergency Department Visits, and Deaths | Hospital discharge to 90 days after discharge | Number of patients experiencing at least one of the composite endpoint measures within 90 days of hospital discharge. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ultrafiltration Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure. | 19 |
| Usual & Customary Care Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure. | 17 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Death | 4 | 4 |
| Overall Study | Physician Decision | 0 | 2 |
| Overall Study | Severe Aortic Stenosis | 1 | 0 |
| Overall Study | Transplant | 0 | 3 |
Baseline characteristics
| Characteristic | Ultrafiltration | Usual & Customary Care | Total |
|---|---|---|---|
| Age Continuous | 60 years STANDARD_DEVIATION 9.1 | 59 years STANDARD_DEVIATION 15.5 | 59.5 years STANDARD_DEVIATION 12 |
| Glomerular Filtration Rate (GFR) GFR <50 mL/min/1.73m2 | 10 Participants | 7 Participants | 17 Participants |
| Glomerular Filtration Rate (GFR) GFR >50 mL/min/1.73m2 | 9 Participants | 10 Participants | 19 Participants |
| Region of Enrollment United States | 19 participants | 17 participants | 36 participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 7 Participants |
| Sex: Female, Male Male | 16 Participants | 13 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 19 / 19 | 17 / 17 |
| serious Total, serious adverse events | 4 / 19 | 4 / 17 |
Outcome results
Primary
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)
Population: Analysis was performed on the intent-to-treat group which consisted of all patients enrolled in this study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ultrafiltration | 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. | 22.0 hours | Standard Deviation 4.2 |
| Usual & Customary Care | 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. | 34.8 hours | Standard Deviation 6.7 |
Secondary
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.
Time frame: Hospital discharge to 90 days after discharge
Population: The analysis population is the intent-to-treat group which includes all patients enrolled on the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ultrafiltration | Composite Endpoint of Hospital Readmissions, Emergency Department Visits, and Deaths | 12 participants |
| Usual & Customary Care | Composite Endpoint of Hospital Readmissions, Emergency Department Visits, and Deaths | 10 participants |
Secondary
Time to Discharge From the Heart Failure (HF) Unit, and Time to Discharge From the Hospital.
Time frame: Time from admission to endpoint achievement
Population: The analysis population was the intent-to-treat group, represented by all patients enrolled in this study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ultrafiltration | Time to Discharge From the Heart Failure (HF) Unit, and Time to Discharge From the Hospital. | Time to discharge from HF unit | 3.63 Days | Standard Deviation 2.11 |
| Ultrafiltration | Time to Discharge From the Heart Failure (HF) Unit, and Time to Discharge From the Hospital. | Time to discharge from hospital | 6.98 Days | Standard Deviation 4.81 |
| Usual & Customary Care | Time to Discharge From the Heart Failure (HF) Unit, and Time to Discharge From the Hospital. | Time to discharge from HF unit | 3.56 Days | Standard Deviation 1.86 |
| Usual & Customary Care | Time to Discharge From the Heart Failure (HF) Unit, and Time to Discharge From the Hospital. | Time to discharge from hospital | 18.93 Days | Standard Deviation 18.9 |
Secondary
Total Volume Removal During the Intervention Period
Time frame: Intervention start to end.
Population: The analysis population is the intent-to-treat group which includes all patients enrolled on the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ultrafiltration | Total Volume Removal During the Intervention Period | 5215 milliliters | Standard Deviation 3406 |
| Usual & Customary Care | Total Volume Removal During the Intervention Period | 2167 milliliters | Standard Deviation 2380 |
Secondary
Volume Removal Rate.
Hours of therapy required to remove 1 liter of fluid normalized to body weight.
Time frame: Intervention start to end.
Population: The analysis population is the intent-to-treat group which includes all patients enrolled on the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ultrafiltration | Volume Removal Rate. | 3.4 milliliters/hour/kilogram | Standard Deviation 2.6 |
| Usual & Customary Care | Volume Removal Rate. | 0.7 milliliters/hour/kilogram | Standard Deviation 1.1 |