Safety and Performance Evaluation of the Nephronyx System for the Treatment of Patients With ADHF

Launched by NEPHRONYX LTD · Feb 26, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called the Nephronyx System for patients with Acute Decompensated Heart Failure (ADHF), a serious condition where the heart struggles to pump blood effectively. The trial aims to determine if this system is safe and effective for patients who have too much fluid in their bodies and are not responding well to traditional diuretic medications, which are used to help remove excess fluid.

To participate in the study, patients must be hospitalized with a diagnosis of ADHF and show signs of fluid overload. They should also have specific measurements related to heart function and fluid levels. Eligible participants will be adults aged 65 to 74, regardless of gender. During the trial, participants will receive the Nephronyx System treatment and will be monitored for safety and how well the treatment works. It's important to know that certain medical conditions, like severe infections or active blood clots, may prevent someone from joining the study. This trial is currently recruiting participants, and those interested should consult their healthcare provider for more details.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient admitted to the hospital with a primary diagnosis of ADHF
• • Patient has signs of volume overload as evidence by a score of ≥ 4 on the EVEREST score
• • Patient with Left Ventricular Ejection Fraction LVEF \>15%
• • Patient has compromised response to diuretics
• • NT-proBNP \>450 pg/mL if aged \<55 years, \>900 pg/mL if aged between 55 and 75 years and \>1800 pg/mL if aged \>75 years
• Exclusion Criteria:
• • Patient with active DVT or history of DVT
• • Patient has documented or evidence of Renal artery stenosis
• • BMI\>35 Kg/m\^2
• • Patient has documented, untreated symptomatic coronary artery disease (CAD) requiring revascularization
• • Patient is in Cardiogenic shock
• • Patient has blood dyscrasia, acute anemia, thrombocytopenia, bleeding diathesis, or coagulopathy
• • Temperature \> 38°C, or sepsis, or active systemic infection requiring IV anti-microbial treatment
• • Patient has shown liver cirrhosis or has signs of liver damage