Comparing ultrafiltration and IV diuretics for heart failure treatment
A Randomized Controlled Study to Evaluate the Safety and Effectiveness of the Aquadex System in Patients With Heart Failure and Fluid Overload
This study tests whether a new machine that removes extra fluid can help people with worsening heart failure feel better compared to the usual IV medications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 372 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nuwellis, Inc. Industry-sponsored |
| Locations | 17 sites (Tucson, Arizona and 16 other locations) |
| Trial ID | NCT05318105 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of adjustable ultrafiltration using the Aquadex System compared to traditional IV loop diuretics in patients experiencing worsening heart failure and fluid overload. Participants will be randomly assigned to receive either treatment to assess clinical outcomes related to fluid management. The study aims to determine which method provides better relief from symptoms and improves patient outcomes during hospitalization.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are hospitalized with acute decompensated heart failure and exhibit signs of fluid overload.
Not a fit: Patients with a new diagnosis of heart failure or those with severe comorbid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a more effective treatment option for patients with worsening heart failure and fluid overload.
How similar studies have performed: Previous studies have shown promise in using ultrafiltration for fluid management in heart failure, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years or older * Man, or non-pregnant woman * Admitted to the hospital with a diagnosis of acute decompensated heart failure * On regularly prescribed oral loop diuretics, Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors or a Mineralcorticoid Receptor Antagonists (MRA) prior to admission * Fluid overload manifested by at least three clinical indications (e.g., edema, an excess of at least 10 pounds of fluid, etc.) * Provide written informed consent Exclusion Criteria: * New diagnosis of heart failure * Acute coronary syndromes * Creatinine ≥ 3.0 mg/dl or planned renal replacement therapies at the time of enrollment * Contraindications to systemic anticoagulation * Severe concomitant disease expected to prolong hospitalization or cause death in less than 90 days * Sepsis or ongoing systemic infection * Active myocarditis * Constrictive pericarditis or restrictive cardiomyopathy * Severe aortic stenosis * Any condition in the opinion of the investigator that would prevent the patient from follow-up/survival
Where this trial is running
Tucson, Arizona and 16 other locations
- Banner Health — Tucson, Arizona, United States (Recruiting)
- MemorialCare, Long Beach Medical Center — Long Beach, California, United States (Recruiting)
- Sharp Memorial Hospital, San Diego Cardiac Center — San Diego, California, United States (Recruiting)
- University of California San Francisco — San Francisco, California, United States (Withdrawn)
- BayCare Medical Group, Morton Plant — Clearwater, Florida, United States (Completed)
- St. Joseph's Hospital — Tampa, Florida, United States (Withdrawn)
- University of Kentucky — Lexington, Kentucky, United States (Recruiting)
- Henry Ford Health — Detroit, Michigan, United States (Recruiting)
- Mount Sinai Morningside — New York, New York, United States (Recruiting)
- The Mount Sinai Hospital — New York, New York, United States (Recruiting)
- Northwell Health — New York, New York, United States (Recruiting)
- The Christ Hospital — Cincinnati, Ohio, United States (Recruiting)
- The Ohio State University — Columbus, Ohio, United States (Recruiting)
- Abington Jefferson Health — Abington, Pennsylvania, United States (Recruiting)
- Jackson Madison County General Hospital — Jackson, Tennessee, United States (Recruiting)
- Baylor Scott & White Research Institute — Dallas, Texas, United States (Recruiting)
- Sentara Norfolk General Heart Hospital — Norfolk, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Sean Pinney, MD — Mount Sinai Morningside
- Study coordinator: Megan Cotts
- Email: megan.cotts@nuwellis.com
- Phone: 952-345-4217
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.