Actively Recruiting
DRAIN-HF: Diuretics Alone versus Aortix Endovascular Device for Acute Heart Failure
Led by Procyrion · Updated on 2026-06-02
320
Participants Needed
48
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the Aortix System, a circulatory support device, compared to standard medical care in patients hospitalized with acute decompensated heart failure (ADHF) who have persistent congestion despite usual treatments and diuretic resistance. This study is prospective, multi-center, randomized, and nonblinded, aiming to assess safety and effectiveness in adults aged 21 and older, regardless of their heart's ejection fraction. An additional registry will enroll patients needing improved kidney function before advanced heart failure treatments like LVAD or transplant. Participants will be randomized 1:1 to receive either the Aortix device or standard medical therapy following a diuretic care algorithm. The registry arm includes patients slated for advanced therapies who will all receive Aortix support. The study plans to enroll up to 320 patients across multiple sites, with 240 in the randomized groups and 80 in the registry. The device is placed endovascularly, and standard care involves maximal tolerated diuretic therapy. Throughout the study, participants will be closely monitored for safety and effectiveness outcomes including major adverse events through 30 days, fluid loss over 7 days, and rates of mortality or heart failure rehospitalization. Assessments include kidney function tests, heart failure symptom evaluations, laboratory markers, and body weight tracking. Follow-up visits will extend to 30 days to evaluate these measures and ensure participant safety and adherence to the protocol.
CONDITIONS
Brief Title
Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 21 years or older with acute decompensated heart failure admitted to the hospital
- Patients on maximally tolerated diuretic therapy not achieving sufficient urine output or fluid loss
- Persistent signs of congestion such as at least 2+ pitting edema or elevated jugular venous pressure >12 cm water after diuretic treatment
- Able to provide written informed consent
- Negative pregnancy test for patients of childbearing potential
You will not qualify if you...
- Use of high dose intravenous inotropes or vasopressors within 48 hours prior to enrollment
- Ongoing low blood pressure (systolic <90 mmHg or MAP <60 mmHg) lasting more than 30 minutes
- Acute kidney failure with serum creatinine ≥4.0 mg/dL or evidence of kidney disease such as nephrotic syndrome
- History of prior kidney transplant, dialysis, or significant kidney surgery within the last 90 days
- Confirmed decompensated cirrhosis or severe liver dysfunction
- Active uncontrolled infection preventing device placement or removal
- Prior heart transplant or planned heart transplant before 30-day follow-up
- Use of mechanical circulatory support devices (LVAD, IABP, ECMO) within specified timeframes
- Confirmed diagnosis of AL amyloidosis
- Recent stroke or acute myocardial infarction within 30 days
- Severe bleeding risk including recent major bleeding, low platelets, or inability to tolerate anticoagulation
- Anatomical issues preventing safe device placement such as unsuitable aortic or vascular anatomy
- Known allergy to device materials or contraindications to study medications
- Participation in other studies that may affect results
- Poor health preventing device procedures or survival to 30-day visit
- Unable or unwilling to undergo study procedures or return for follow-up visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to hospital discharge
Participants receive the Aortix endovascular device or standard medical therapy for acute heart failure while hospitalized.
1 baseline visit during hospitalization
Duration - 30 days after treatment
Participants are monitored for safety and effectiveness outcomes including fluid loss, mortality, and heart failure re-hospitalization.
1 follow-up visit at 30 days post-treatment
Trial Site Locations
Total: 48 locations
1
Banner--University Medical Center Phoenix
Phoenix, Arizona, United States, 85006
Actively Recruiting
2
Mayo Clinic - Arizona
Phoenix, Arizona, United States, 85054
Actively Recruiting
3
HonorHealth Medical Center
Scottsdale, Arizona, United States, 85258
Terminated
4
John Muir Health
Concord, California, United States, 94520
Actively Recruiting
5
Zuckerberg San Francisco General
San Francisco, California, United States, 94110
Actively Recruiting
6
San Francisco Veterans Administration
San Francisco, California, United States, 94121
Terminated
7
University of California San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
8
Ascension Sacred Heart
Pensacola, Florida, United States, 32504
Withdrawn
9
Tallahassee Research Institute
Tallahassee, Florida, United States, 32308
Terminated
10
University of South Florida
Tampa, Florida, United States, 33606
Actively Recruiting
11
BayCare Medical/St. Joseph's Hospital
Tampa, Florida, United States, 33607
Actively Recruiting
12
AdventHealth Tampa
Tampa, Florida, United States, 33613
Actively Recruiting
13
Cleveland Clinic Florida
Weston, Florida, United States, 33331
Actively Recruiting
14
Emory University Hospital
Atlanta, Georgia, United States, 30308
Actively Recruiting
15
Piedmont Healthcare Inc.
Augusta, Georgia, United States, 30309
Actively Recruiting
16
Wellstar Research Institue
Marietta, Georgia, United States, 30060
Active, Not Recruiting
17
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
18
Advocate IMMC
Chicago, Illinois, United States, 60657
Actively Recruiting
19
Advocate Aurora - Good Samaritan
Downers Grove, Illinois, United States, 60515
Active, Not Recruiting
20
Ascension via Christi Kansas
Wichita, Kansas, United States, 67226
Terminated
21
University of Michigan, Cardiovascular Medicine
Ann Arbor, Michigan, United States, 48109
Withdrawn
22
Henry Ford
Detroit, Michigan, United States, 48202
Actively Recruiting
23
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Actively Recruiting
24
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
25
Jersey Shore University Medical Center
Neptune City, New Jersey, United States, 07753
Actively Recruiting
26
New York Presbyterian - Brooklyn Methodist Hospital
Brooklyn, New York, United States, 11215
Actively Recruiting
27
Mount Sinai Morningside
New York, New York, United States, 10025
Actively Recruiting
28
Nyph/Cumc
New York, New York, United States, 10032
Actively Recruiting
29
Northwell Health (Lenox Hill)
New York, New York, United States, 10075
Terminated
30
Nuvance Health
Poughkeepsie, New York, United States, 12601
Actively Recruiting
31
Northwell Health (Staten Island)
Staten Island, New York, United States, 10305
Actively Recruiting
32
Atrium Health Sanger Heart and Vascular Institute
Charlotte, North Carolina, United States, 28204
Actively Recruiting
33
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
34
Novant Health New Hanover Regional Medical Center
Wilmington, North Carolina, United States, 28401
Withdrawn
35
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
36
Oklahoma Cardiovascular Research Group
Oklahoma City, Oklahoma, United States, 73120
Actively Recruiting
37
Oregon Health & Sciences University
Portland, Oregon, United States, 97239
Active, Not Recruiting
38
Jefferson Abington Hospital
Abington, Pennsylvania, United States, 19001
Actively Recruiting
39
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
40
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
41
AnMed Health
Anderson, South Carolina, United States, 29621
Actively Recruiting
42
Baylor Scott & White
Fort Worth, Texas, United States, 76104
Withdrawn
43
Texas Heart Institute
Houston, Texas, United States, 77030
Actively Recruiting
44
Baylor Scott & White
Plano, Texas, United States, 75093
Withdrawn
45
Intermountain Health
Murray, Utah, United States, 84107
Withdrawn
46
University of Virginia
Charlottesville, Virginia, United States, 22908
Terminated
47
Virginia Commonwealth University
Richmond, Virginia, United States, 23219
Actively Recruiting
48
Semmelweis University
Budapest, Hungary
Actively Recruiting
Research Team
R
Rubi Reyes-Fuentez
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here