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Tests treatment safety and results for Acute Decompensated Heart Failure
Official title Safety and Performance Evaluation of the Nephronyx System for the Treatment of Patients With ADHF
ClinicalTrials.gov ID: NCT05759806
What this study is testing
- What it's testing
- The objective of this interventional study is to evaluate the safety and functional performance of the Nephronyx System in patients with ADHF, presenting clinical signs of volume overload and compromised response to diuretics.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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 \ 900 pg/mL if aged between 55 and 75 years and \>1800 pg/mL if aged \>75 years
You likely can't join if
- 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
See the full eligibility 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 \ 900 pg/mL if aged between 55 and 75 years and \>1800 pg/mL if aged \>75 years
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Haifa, Israel
- Jerusalem, Israel
- Poria Illit, Israel
- Rehovot, Israel
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Haifa, Israel; Jerusalem, Israel; Poria Illit, Israel; Rehovot, Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.