drugset / Trial / NCT05965934

Management of Volume Overload HF Patients by Individual DSR Treatment adJustment-a clinicAl inVestigation of InfusatE2.0

NCT05965934

Phase 1/2 Unknown 33 enrolled Sequana Medical N.V.
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is a multi-center, prospective, randomized (2:1), open-label study to evaluate the safety and efficacy of DSR therapy using the Infusate 2.0 peritoneal solution (composed of 30% icodextrin and 10% dextrose) in diuretic resistant patients with HF and persistent volume overload.

Timeline

Start
2023-07-07
Primary completion
2024-12-31
Completion
2025-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Infusate 2.0 Unknown Other
Background Dapagliflozin Small molecule

Indications