Heart Failure Clinical Trial

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

Summary

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.

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Full Description

The aim of the proposed AVOID-HF study is to confirm and expand the findings that fluid removal by AQ reduces HF rehospitalizations at 90 days as well as the length of these HF rehospitalizations. In the "Ultrafiltration Versus Intravenous Diuretics for Patients Hospitalized for Acute Decompensated Heart Failure" (UNLOAD) study, the 90 day HF re-hospitalizations were pre-specified secondary end-points. AVOID-HF is designed with a primary end-point to determine if AQ reduces the number of HF events (Rehospitalization or unscheduled outpatient or emergency room treatment for HF) after discharge from index hospitalization compared to IV loop diuretics. AVOID will also explore days alive and out of the hospital as a secondary end-point, which was not done in UNLOAD. In other words, the AVOID-HF study is going beyond studying only the amount of fluid removal and will explore whether the modality of fluid removal influences HF outcomes.

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Eligibility Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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

Study is for people with:

Heart Failure

Estimated Enrollment:

224

Study ID:

NCT01474200

Recruitment Status:

Terminated

Sponsor:

Nuwellis, Inc.

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There are 38 Locations for this study

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Heart Center Research
Huntsville Alabama, 35801, United States
Mayo Clinic - Scottsdale
Scottsdale Arizona, 85054, United States
Scottsdale Healthcare Research Institute
Scottsdale Arizona, 85258, United States
UCLA
Los Angeles California, 90095, United States
University of California, San Diego (UCSD)
San Diego California, 92037, United States
San Diego Cardiac Center
San Diego California, 92123, United States
Washington Hospital Center
Washington District of Columbia, 20010, United States
Morton Plant Medical Center
Clearwater Florida, 33756, United States
Emory University
Atlanta Georgia, 30322, United States
Northwestern University
Evanston Illinois, 60208, United States
Edward Hospital Center for Advanced Heart Failure
Naperville Illinois, 60566, United States
Advocate Health & Hospitals Corporation
Oakbrook Terrace Illinois, 60181, United States
Elkhart General HealthCare
Elkhart Indiana, 46514, United States
Northern Indiana Research Alliance
Fort Wayne Indiana, 46804, United States
Iowa Health - Des Moines
Des Moines Iowa, 50316, United States
Hennepin County Medical Center
Minneapolis Minnesota, 55415, United States
Minneapolis VA Medical Center
Minneapolis Minnesota, 55417, United States
University of Minnesota
Minneapolis Minnesota, 55455, United States
Saint Luke's Hospital and Saint Luke's Cardiovascular Consultants
Kansas City Missouri, 64111, United States
AtlantiCare Health Network
Egg Harbor Township New Jersey, 08234, United States
New Mexico Heart Institute/Heart Hospital
Albuquerque New Mexico, 87102, United States
Asheville Cardiology Associates
Asheville North Carolina, 28803, United States
University of Cincinnati
Cincinnati Ohio, 45219, United States
MetroHealth Systems
Cleveland Ohio, 44109, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
The Ohio State University
Columbus Ohio, 43210, United States
Good Samaritan Hospital - Dayton
Dayton Ohio, 45415, United States
Oklahoma Heart Institute and Hillcrest Medical Center
Tulsa Oklahoma, 74104, United States
Abington Memorial Hospital
Abington Pennsylvania, 19001, United States
St. Luke's Hospital and Health Network
Bethlehem Pennsylvania, 18018, United States
Drexel University College of Medicine
Philadelphia Pennsylvania, 19102, United States
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Albert Einstein Medical Center
Philadelphia Pennsylvania, 19141, United States
Saint Thomas Hospital
Nashville Tennessee, 37205, United States
Brooke Army Medical Center
San Antonio Texas, 78234, United States
Virginia Commonwealth University Medical Center
Richmond Virginia, 23298, United States
MultiCare Health System/Tacoma General Hospital
Tacoma Washington, 98405, United States
Aurora St. Luke's Medical Center
Milwaukee Wisconsin, 53215, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

224

Study ID:

NCT01474200

Recruitment Status:

Terminated

Sponsor:


Nuwellis, Inc.

How clear is this clinincal trial information?

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