Rationale and Design of PURE: A Randomized Controlled Trial to Evaluate Peritoneal Ultrafiltration with PolyCore™ in...

Area of Science:

• Cardiology
• Nephrology
• Critical Care Medicine

Background:

• Peritoneal ultrafiltration (PUF) is explored for refractory congestive heart failure (RCHF).
• Limited clinical trial data exist for PUF in RCHF, with current indications for chronic kidney disease.
• PolyCore™ is an innovative PUF solution under investigation.

Purpose of the Study:

• To evaluate the safety and efficacy of PUF using PolyCore™ in RCHF patients.
• To assess the impact of PUF on a composite endpoint of mortality or clinical worsening.
• To explore PUF as an additional therapeutic option for RCHF.

Main Methods:

• A multicenter, randomized, controlled, unblinded, adaptive design clinical trial (PURE study).
• Approximately 84 RCHF patients randomized 1:1 to standard therapy or standard therapy plus PUF.
• Primary endpoint: composite of mortality or worsening condition (hospitalization, increased diuretic dose, renal function decline) at 7 months.

Main Results:

• Study is about to start; results are pending.
• Safety will be evaluated for up to 12 months.
• Statistical analysis includes survival analysis and sensitivity analyses.

Conclusions:

• The PURE study will assess PolyCore™ PUF for RCHF patients on guideline-directed medical therapy.
• A successful outcome is expected to improve RCHF symptoms and reduce hospitalizations.
• This trial may establish PUF as a viable treatment for RCHF.