RecruitingNot ApplicableNCT05677100

Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure

DRAIN-HF: Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure

Sponsor

Procyrion

Enrollment

320 participants

Start Date

Aug 23, 2023

Study Type

INTERVENTIONAL

Conditions

Heart Failure Heart Failure, Diastolic Cardiorenal Syndrome Cardio-Renal Syndrome ADHF Heart Failure, Systolic Heart Failure; With Decompensation Heart Failure, Congestive

Summary

Aortix is a circulatory support device for chronic heart failure patients on medical management who have been hospitalized for acute decompensated heart failure (ADHF) and have persistent congestion despite usual medical therapy. Eligible ADHF patients with diuretic resistance (irrespective of ejection fraction) will be enrolled and randomized 1:1 to either the Aortix system or standard of care medical management.

Eligibility

Min Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study — called DRAIN-HF — is testing a device called Aortix, which is inserted into the body's main artery to help the kidneys remove excess fluid in patients with acute heart failure who are not responding well to diuretics (water pills). The study compares the device plus standard care against diuretics alone. **You may be eligible if...** - You are hospitalized with a primary diagnosis of worsening heart failure - You are not responding adequately to high-dose IV diuretics (you are not producing enough urine) - You still have significant fluid buildup (swollen legs, elevated neck vein pressure, or belly fluid) despite IV diuretics - You are over 21 years old **You may NOT be eligible if...** - You have very low blood pressure, are on vasopressors, or require high-dose IV heart pump drugs - You have severe kidney failure, liver failure, or active infection - You have had a recent heart attack, stroke, or major surgery within 30 days - You have certain aortic or vascular anatomy that makes the device unsafe - You have a serious bleeding risk or cannot tolerate blood thinners - You have had or are planned for a heart transplant or long-term heart pump (LVAD) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAortix System

Aortix is a circulatory support device for chronic heart failure patients on medical management who have been hospitalized for acute decompensated heart failure (ADHF) and are resistant to diuretic therapy.

Locations(48)

Banner--University Medical Center Phoenix

Phoenix, Arizona, United States

Mayo Clinic - Arizona

Phoenix, Arizona, United States

HonorHealth Medical Center

Scottsdale, Arizona, United States

John Muir Health

Concord, California, United States

Zuckerberg San Francisco General

San Francisco, California, United States

San Francisco Veterans Administration

San Francisco, California, United States

University of California San Francisco

San Francisco, California, United States

Ascension Sacred Heart

Pensacola, Florida, United States

Tallahassee Research Institute

Tallahassee, Florida, United States

University of South Florida

Tampa, Florida, United States

BayCare Medical/St. Joseph's Hospital

Tampa, Florida, United States

AdventHealth Tampa

Tampa, Florida, United States

Cleveland Clinic Florida

Weston, Florida, United States

Emory University Hospital

Atlanta, Georgia, United States

Piedmont Healthcare Inc.

Augusta, Georgia, United States

Wellstar Research Institue

Marietta, Georgia, United States

University of Chicago

Chicago, Illinois, United States

Advocate IMMC

Chicago, Illinois, United States

Advocate Aurora - Good Samaritan

Downers Grove, Illinois, United States

Ascension via Christi Kansas

Wichita, Kansas, United States

University of Michigan, Cardiovascular Medicine

Ann Arbor, Michigan, United States

Henry Ford

Detroit, Michigan, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Jersey Shore University Medical Center

Neptune City, New Jersey, United States

New York Presbyterian - Brooklyn Methodist Hospital

Brooklyn, New York, United States

Mount Sinai Morningside

New York, New York, United States

Nyph/Cumc

New York, New York, United States

Northwell Health (Lenox Hill)

New York, New York, United States

Nuvance Health

Poughkeepsie, New York, United States

Northwell Health (Staten Island)

Staten Island, New York, United States

Atrium Health Sanger Heart and Vascular Institute

Charlotte, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

Novant Health New Hanover Regional Medical Center

Wilmington, North Carolina, United States

The Ohio State University

Columbus, Ohio, United States

Oklahoma Cardiovascular Research Group

Oklahoma City, Oklahoma, United States

Oregon Health & Sciences University

Portland, Oregon, United States

Jefferson Abington Hospital

Abington, Pennsylvania, United States

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

AnMed Health

Anderson, South Carolina, United States

Baylor Scott & White

Fort Worth, Texas, United States

Texas Heart Institute

Houston, Texas, United States

Baylor Scott & White

Plano, Texas, United States

Intermountain Health

Murray, Utah, United States

University of Virginia

Charlottesville, Virginia, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Semmelweis University

Budapest, Hungary

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NCT05677100

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