Study of PolyCore Peritoneal Ultrafiltration Added to Heart Failure Medications in Adults with Reduced Heart Pump Function to Prevent Heart Failure Worsening

What this Trial Is About

Researchers are evaluating the safety and effectiveness of PolyCore peritoneal ultrafiltration PUF in adults with heart failure and reduced ejection fraction HFrEF who continue to experience symptoms despite standard medical treatment. This randomized, controlled, unblinded trial aims to compare PolyCore PUF plus usual heart failure medications versus stable medical therapy alone in this population. The study includes an adaptive design with an interim analysis to determine final study size, overseen by an independent safety monitoring board. Participants are randomly assigned to one of two groups one receiving PolyCore PUF treatment for six months alongside their regular heart failure medications, and the other receiving only stable medical therapy including loop diuretics without PUF. The PolyCore PUF involves a single nightly exchange of 2 liters of PolyCore solution lasting 12 to 14 hours each night over six months. The control group continues their prescribed medications without PUF therapy. During the study, participants will be monitored through several assessments including walking distance tests, quality of life questionnaires, measurement of heart failure biomarkers, kidney function, medication usage, hospital resource use, and heart failure severity classification. These evaluations occur at 3, 6, and 7 months after randomization, with safety monitored throughout approximately one year. The primary outcome is a combined measure of mortality and worsening heart failure condition up to seven months after starting treatment.

Peritoneal Ultrafiltration in Cardio Renal Syndrome.