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

Last updated: August 3, 2023
Sponsor: Nuwellis, Inc.
Overall Status: Terminated

Phase

N/A

Condition

Chest Pain

Heart Failure

Hyponatremia

Treatment

Isolated veno-venous ultrafiltration (AQ)

IV Loop Diuretics (LD)

Clinical Study ID

NCT01474200
1494
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 18 years of age or older
  2. Male or non-pregnant female patients
  3. Admitted to the hospital with a primary diagnosis of acute decompensated heart failure (ADHF)
  4. On regularly scheduled oral loop diuretics prior to admission
  5. Fluid overload manifested by at least two of the following:
  6. Pitting edema (2+) of the lower extremities
  7. Jugular venous distention > 8 cm
  8. Pulmonary edema or pleural effusion on chest x-ray
  9. Paroxysmal nocturnal dyspnea or ≥ two- pillow orthopnea
  10. Respiration rate ≥ 20 per minute.
  11. Have received ≤ 2 IV loop diuretics doses before randomization
  12. Must be able to be enrolled into the trial ≤ 24 hours of their admission to thehospital.
  13. Provide written informed consent form as required by the local IRB (InstitutionalReview Board)

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 224
Treatment Group(s): 2
Primary Treatment: Isolated veno-venous ultrafiltration (AQ)
Phase:
Study Start date:
January 01, 2012
Estimated Completion Date:
July 31, 2014

Study 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.

Connect with a study center

  • Heart Center Research

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • Mayo Clinic - Scottsdale

    Scottsdale, Arizona 85054
    United States

    Site Not Available

  • Scottsdale Healthcare Research Institute

    Scottsdale, Arizona 85258
    United States

    Site Not Available

  • UCLA

    Los Angeles, California 90095
    United States

    Site Not Available

  • San Diego Cardiac Center

    San Diego, California 92123
    United States

    Site Not Available

  • University of California, San Diego (UCSD)

    San Diego, California 92037
    United States

    Site Not Available

  • John Muir Medical Center

    Walnut Creek, California 94597
    United States

    Site Not Available

  • Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Morton Plant Medical Center

    Clearwater, Florida 33756
    United States

    Site Not Available

  • Emory University

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Redmond Regional Medical Center

    Rome, Georgia 30165
    United States

    Site Not Available

  • Northwestern University

    Evanston, Illinois 60208
    United States

    Site Not Available

  • Edward Hospital Center for Advanced Heart Failure

    Naperville, Illinois 60566
    United States

    Site Not Available

  • Advocate Health & Hospitals Corporation

    Oakbrook Terrace, Illinois 60181
    United States

    Site Not Available

  • Elkhart General HealthCare

    Elkhart, Indiana 46514
    United States

    Site Not Available

  • Northern Indiana Research Alliance

    Fort Wayne, Indiana 46804
    United States

    Site Not Available

  • Iowa Health - Des Moines

    Des Moines, Iowa 50316
    United States

    Site Not Available

  • Hennepin County Medical Center

    Minneapolis, Minnesota 55415
    United States

    Site Not Available

  • Minneapolis VA Medical Center

    Minneapolis, Minnesota 55417
    United States

    Site Not Available

  • University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Saint Luke's Hospital and Saint Luke's Cardiovascular Consultants

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Mercy Hospital St. Louis

    St. Louis, Missouri 63141
    United States

    Site Not Available

  • Lincoln General Hospital

    Lincoln, Nebraska 68506-1275
    United States

    Site Not Available

  • AtlantiCare Health Network

    Egg Harbor Township, New Jersey 08234
    United States

    Site Not Available

  • New Mexico Heart Institute/Heart Hospital

    Albuquerque, New Mexico 87102
    United States

    Site Not Available

  • New Mexico Heart Institute/Heart Hospital

    Alburquerque, New Mexico 87102
    United States

    Site Not Available

  • Asheville Cardiology Associates

    Asheville, North Carolina 28803
    United States

    Site Not Available

  • University of Cincinnati

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • MetroHealth Systems

    Cleveland, Ohio 44109
    United States

    Site Not Available

  • The Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Good Samaritan Hospital - Dayton

    Dayton, Ohio 45415
    United States

    Site Not Available

  • Oklahoma Heart Institute and Hillcrest Medical Center

    Tulsa, Oklahoma 74104
    United States

    Site Not Available

  • Abington Memorial Hospital

    Abington, Pennsylvania 19001
    United States

    Site Not Available

  • St. Luke's Hospital and Health Network

    Bethlehem, Pennsylvania 18018
    United States

    Site Not Available

  • Albert Einstein Medical Center

    Philadelphia, Pennsylvania 19141
    United States

    Site Not Available

  • Drexel University College of Medicine

    Philadelphia, Pennsylvania 19102
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Saint Thomas Hospital

    Nashville, Tennessee 37205
    United States

    Site Not Available

  • Brooke Army Medical Center

    San Antonio, Texas 78234
    United States

    Site Not Available

  • Virginia Commonwealth University Medical Center

    Richmond, Virginia 23298
    United States

    Site Not Available

  • MultiCare Health System/Tacoma General Hospital

    Tacoma, Washington 98405
    United States

    Site Not Available

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

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