Sequana Medical announces first patient enrolled in RED DESERT – REpeated Dose alfapump® DSR study for Treatment of diuretic-resistant heart failure patients
The study aims to:
- Evaluate the safety of alfapump DSR in patients with heart failure
- Assess the feasibility of alfapump DSR to remove excess sodium and fluid from the body
- Explore the potential impact of DSR therapy to restore response to diuretics
Ghent, Belgium: 7 January 2020 – Sequana Medical NV (Euronext Brussels: SEQUA), an innovator in the management of fluid overload in liver disease, malignant ascites and heart failure, today announces that the first patient has been enrolled in the first-in-human repeated dose study of alfapump DSR (Direct Sodium Removal) for the treatment of diuretic-resistant heart failure patients.
The prospective, single-arm, repeated dose study named RED DESERT is expected to include up to 10 heart failure patients, who are on high dose diuretics, across two centres in Belgium and Georgia. The primary safety endpoints include the rate of device, procedure and/or therapy-related serious adverse events after two and six weeks. The secondary endpoints include the feasibility of alfapump DSR to remove excess sodium and fluid from the body, thereby eliminating the need for daily high dose diuretics during the six-week treatment period. Additional exploratory endpoints to measure the potential impact of DSR therapy to restore response to diuretics will be evaluated through week six. Results are expected to be reported in Q2 and Q3 2020.
More info on Sequana’s website