Study of Heart Failure Hospitalizations After Aquapheresis Therapy Compared to Intravenous (IV) Diuretic Treatment

Stopped early · Not applicable

Conditions studied: Heart Failure, Cardiac Failure, Acute Decompensated Heart Failure (ADHF)

In brief

The purpose of the research is to determine if patients have fewer Heart Failure (HF) events after receiving Aquapheresis (AQ) therapy compared to intravenous (IV) diuretics up to 90 days of discharge from the hospital. Heart Failure events are defined as returning to the hospital, clinic or emergency department (ED) for treatment of HF symptoms.

Key facts

Study ID

NCT01474200

Run by

Nuwellis, Inc.

People needed

224

Starts

2012-01-01

Expected to finish

2014-07-01

Last updated by the study team

2023-08-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years of age or older
• Male or non-pregnant female patients
• Admitted to the hospital with a primary diagnosis of acute decompensated heart failure (ADHF)
• On regularly scheduled oral loop diuretics prior to admission
• Fluid overload manifested by at least two of the following:
• Pitting edema (2+) of the lower extremities
• Jugular venous distention > 8 cm
• Pulmonary edema or pleural effusion on chest x-ray
• Paroxysmal nocturnal dyspnea or ≥ two- pillow orthopnea
• Respiration rate ≥ 20 per minute.
• Have received ≤ 2 IV loop diuretics doses before randomization
• Must be able to be enrolled into the trial ≤ 24 hours of their admission to the hospital.
• Provide written informed consent form as required by the local IRB (Institutional Review Board)

You may not qualify if…

• Acute coronary syndromes
• Renal insufficiency with a sCr ≥ 3.0 mg/dl or planned renal replacement therapies
• Systolic blood pressure < 90 mmHg at time of enrollment
• Pulmonary Arterial Hypertension not secondary to left heart disease
• Contraindications to systemic anticoagulation
• Hematocrit > 45%
• Inability to obtain venous access
• Hemodynamic instability severe enough to require IV positive inotropic agents, IV vasodilators or both
• Use of iodinated radiocontrast material within the previous 72 hours or planned study requiring IV contrast during the current hospitalization
• Severe concomitant disease expected to prolong hospitalization
• Severe concomitant disease expected to cause death in ≤ 90 days
• Sepsis or ongoing systemic infection
• Severe uncorrected valvular stenosis
• Active myocarditis
• Hypertrophic obstructive cardiomyopathy
• Constrictive pericarditis or restrictive cardiomyopathy
• Liver cirrhosis
• Previous solid organ transplant
• Requirement for mechanical ventilatory support
• Presence of a mechanical circulatory support device
• Unwillingness or inability to complete follow up
• Active drug or ETOH substance abuse
• Participating in another interventional clinical trial

Where it is running

• Heart Center Research — Huntsville, Alabama, United States
• Mayo Clinic - Scottsdale — Scottsdale, Arizona, United States
• Scottsdale Healthcare Research Institute — Scottsdale, Arizona, United States
• UCLA — Los Angeles, California, United States
• University of California, San Diego (UCSD) — San Diego, California, United States
• San Diego Cardiac Center — San Diego, California, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Morton Plant Medical Center — Clearwater, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Northwestern University — Evanston, Illinois, United States
• Edward Hospital Center for Advanced Heart Failure — Naperville, Illinois, United States
• Advocate Health & Hospitals Corporation — Oakbrook Terrace, Illinois, United States
• Elkhart General HealthCare — Elkhart, Indiana, United States
• Northern Indiana Research Alliance — Fort Wayne, Indiana, United States
• Iowa Health - Des Moines — Des Moines, Iowa, United States
• Hennepin County Medical Center — Minneapolis, Minnesota, United States
• Minneapolis VA Medical Center — Minneapolis, Minnesota, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Saint Luke's Hospital and Saint Luke's Cardiovascular Consultants — Kansas City, Missouri, United States
• AtlantiCare Health Network — Egg Harbor, New Jersey, United States
• New Mexico Heart Institute/Heart Hospital — Albuquerque, New Mexico, United States
• Asheville Cardiology Associates — Asheville, North Carolina, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• MetroHealth Systems — Cleveland, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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