Evaluating the Nephronyx System for treating acute heart failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Adding extra diuretics to standard care for acute decompensated heart failure

  This trial will test whether adding empagliflozin, acetazolamide, or metolazone to loop diuretics helps adults hospitalized with acute decompensated heart failure remove fluid and feel better.

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• Fluid removal with the Reprieve System for acute decompensated heart failure

  This trial will test whether the Reprieve System removes excess fluid more effectively than standard IV diuretics in adults hospitalized with acute decompensated heart failure who are at risk for diuretic resistance.

  Recruiting at 49 sites Reprieve Cardiovascular, Inc · Irvine, California and 49 other locations · NCT06898515

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.