Evaluating the Nephronyx System for treating acute heart failure
Safety and Performance Evaluation of the Nephronyx System for the Treatment of Patients With ADHF
This study is testing a new system called Nephronyx to see if it can help hospitalized patients with acute heart failure who are struggling with fluid buildup and not getting better with regular treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nephronyx LTD Industry-sponsored |
| Locations | 4 sites (Haifa and 3 other locations) |
| Trial ID | NCT05759806 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to assess the safety and functional performance of the Nephronyx System in patients suffering from acute decompensated heart failure (ADHF) who exhibit signs of volume overload and have a poor response to diuretics. Patients will be monitored for their clinical signs and responses to the Nephronyx system, which is designed to improve fluid management in this population. The study will include hospitalized patients with specific inclusion criteria related to heart function and biomarkers.
Who should consider this trial
Good fit: Ideal candidates are hospitalized patients diagnosed with acute decompensated heart failure who show signs of volume overload and have a compromised response to diuretics.
Not a fit: Patients with active deep vein thrombosis, significant coronary artery disease, or those in cardiogenic shock are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve fluid management and outcomes for patients with acute heart failure.
How similar studies have performed: While this approach is innovative, similar studies evaluating advanced fluid management systems have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Haifa and 3 other locations
- Rambam Medical Center — Haifa, Israel (Recruiting)
- Shaare Zedek Medical Center — Jerusalem, Israel (Recruiting)
- The Baruch Padeh Medical Center, Poriya — Poria Illit, Israel (Recruiting)
- Kaplan Medical Center — Rehovot, Israel (Recruiting)
Study contacts
- Study coordinator: Sagy Karavany
- Email: sagy@nephronyx.com
- Phone: 972-8-9999734
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.