Phase 4
Completed N=36
Extracorporeal Ultrafiltration (UF) vs. Usual and Customary Care for Patients With Severe Heart Failure (HF)
Heart Failure · CHF
Source: ClinicalTrials.gov NCT00288587 ↗
Enrolled (actual)
36
Serious AEs
22.2%
Results posted
Jun 2012
Primary outcomePrimary: 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; 34.8 hours
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
22.0; 34.8 | — |
| SECONDARY Time to Discharge From the Heart Failure (HF) Unit, and Time to Discharge From the Hospital. |
3.63; 3.56; 6.98; 18.93 | — |
| SECONDARY Total Volume Removal During the Intervention Period |
5215; 2167 | — |
| SECONDARY Volume Removal Rate. |
3.4; 0.7 | — |
| SECONDARY Composite Endpoint of Hospital Readmissions, Emergency Department Visits, and Deaths |
12; 10 | — |
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT00288587). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.