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The study was stopped early due to slow enrollment and was a business decision. This decision was not based on any efficacy or safety concerns.
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The REVERSE-HF study is a randomized controlled trial to evaluate clinical outcomes of adjustable ultrafiltration with the Aquadex System as compared to adjustable IV loop diuretics in patients with worsening heart failure (HF) and fluid overload.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aquadex ultrafiltration therapy | Experimental |
| |
| IV loop diuretics | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aquadex Smartflow® System | Device | ultrafiltration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first heart failure (HF) event | Heart Failure (HF) event defined as any HF rehospitalization or unplanned use of IV loop diuretics, vasoactive medications or Aquadex therapy in any outpatient setting. | within 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Win ratio analysis | Win ratio analysis of cardiovascular (CV) mortality, HF events and quality of life | within 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sean Pinney, MD | Mount Sinai Morningside | Principal Investigator |
| Maria DeVita, MD, FASN | Lenox Hill Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Health | Tucson | Arizona | 85721 | United States | ||
| MemorialCare, Long Beach Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36787124 | Derived | McCallum W, Sarnak MJ. Cardiorenal Syndrome in the Hospital. Clin J Am Soc Nephrol. 2023 Jul 1;18(7):933-945. doi: 10.2215/CJN.0000000000000064. Epub 2023 Jan 13. |
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| IV Loop Diuretics |
| Drug |
diuretics |
|
| Long Beach |
| California |
| 90806 |
| United States |
| Sharp Memorial Hospital, San Diego Cardiac Center | San Diego | California | 92123 | United States |
| BayCare Medical Group, Morton Plant | Clearwater | Florida | 33756 | United States |
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
| Henry Ford Health | Detroit | Michigan | 48202 | United States |
| Mount Sinai Morningside | New York | New York | 10025 | United States |
| The Mount Sinai Hospital | New York | New York | 10029 | United States |
| Northwell Health | New York | New York | 10075 | United States |
| The Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| The Ohio State University | Columbus | Ohio | 43215 | United States |
| Abington Jefferson Health | Abington | Pennsylvania | 19001 | United States |
| Jackson Madison County General Hospital | Jackson | Tennessee | 38301 | United States |
| Baylor Scott & White Research Institute | Dallas | Texas | 75207 | United States |
| Sentara Norfolk General Heart Hospital | Norfolk | Virginia | 23507 | United States |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D004487 | Edema |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D049994 | Sodium Potassium Chloride Symporter Inhibitors |
| ID | Term |
|---|---|
| D049990 | Membrane Transport Modulators |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004232 | Diuretics |
| D045283 | Natriuretic Agents |
| D045505 | Physiological Effects of Drugs |
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