Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Stepped pharmacologic care · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Stepped pharmacologic care | ACTIVE_COMPARATOR | Stepped care will provide treating physicians with guidelines for the intensification of diuretic therapy and the possible use of vasodilators and inotropes. |
| Ultrafiltration | EXPERIMENTAL | All loop diuretics will be discontinued. Treatment will involve slow continuous ultrafiltration until an optimal volume status has been achieved. Ultrafiltration therapy will be initiated after the placement of appropriate intravenous access and will continue until the participant's signs and symptoms of congestion have been optimized. Fluid status will be managed exclusively by ultrafiltration using the Aquadex system 100 (CHF Solutions, Inc.) according to the manufacturer's specifications. The use of vasodilators or inotropic agents will be prohibited unless deemed necessary for rescue therapy. |
| Name | Type | Description |
|---|---|---|
| Stepped pharmacologic care | DRUG | Stepped care will provide treating physicians with guidelines for the intensification of diuretic therapy and the possible use of vasodilators and inotropes. |
| Ultrafiltration | DEVICE | All loop diuretics will be discontinued. Treatment will involve slow continuous ultrafiltration until an optimal volume status has been achieved. Ultrafiltration therapy will be initiated after the placement of appropriate intravenous access and will continue until the participant's signs and symptoms of congestion have been optimized. Fluid status will be managed exclusively by ultrafiltration using the Aquadex system 100 (CHF Solutions, Inc.) according to the manufacturer's specifications. The use of vasodilators or inotropic agents will be prohibited unless deemed necessary for rescue therapy. |
Inclusion criteria: * age 18 or older * admitted to the hospital with a primary diagnosis of decompensated heart failure * onset of cardiorenal syndrome after hospitalization or pre-hospitalization * after hospitalization - onset of cardiorenal syndrome after hospitalization must occur within 10 da...
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Stepped pharmacologic care is an investigational treatment being studied for heart failure. It is being evaluated in the context of acute decompensated heart failure and cardiorenal syndrome. The drug is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
Stepped pharmacologic care is being developed by Nuwellis, Inc., a company traded on the NASDAQ under the ticker symbol NUWE. The company is conducting clinical research to evaluate this treatment for heart failure patients.
Stepped pharmacologic care is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved for commercial use. The Phase 3 trial has been completed, and the drug remains under investigation for heart failure.
Stepped pharmacologic care has been studied in one completed Phase 3 clinical trial, identified as NCT00608491. This trial, known as the CARRESS Study, evaluated the effectiveness of ultrafiltration in treating people with acute decompensated heart failure and cardiorenal syndrome. The trial enrolled 188 participants in the United States and Canada.
Stepped pharmacologic care is a treatment approach that was compared against ultrafiltration in the CARRESS Study. The trial was designed to evaluate the effectiveness of ultrafiltration in treating acute decompensated heart failure and cardiorenal syndrome, with stepped pharmacologic care serving as the active control.