CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 36 enrolled
Drug / intervention
IV loop diuretic +1 moredrug
Likely dose
IV loop diuretic (conventional therapy) or extracorporeal ultrafiltration via NxStage System One deviceAI-extracted
Key inclusion· 5
  • ✓NYHA Class III or IV heart failure
  • ✓Left ventricular ejection fraction less than 40%
  • ✓Pulmonary artery catheter in place
  • ✓Mean pulmonary artery occlusion pressure at least 20 mm Hg
Key exclusion· 14
  • ✕Already on renal replacement therapy or expected to need it at enrollment
  • ✕Estimated glomerular filtration rate less than 15 mL/min
  • ✕Systolic blood pressure less than 80 mm Hg
  • ✕Acute coronary syndrome

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00288587
NCT00288587Phase 4Completed
CompareCT.gov

CP0007: Extracorporeal Ultrafiltration (UF) vs. Usual and Customary Care for Patients With Severe Heart Failure (HF)

NxStage Medical·interventional·Posted Feb 8, 2006·Updated Jun 19, 2012

In Brief

A Phase 4 clinical trial evaluating IV loop diuretic and NxStage System One for Heart Failure and CHF. Completed, enrolled 36 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure, CHF
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 8, 2006
Enrollment StartOct 1, 2003
Primary CompletionSep 1, 2008
Study CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 20.4 years ago

Interventions

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.