Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure
DRAIN-HF
DRAIN-HF: Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure
1 other identifier
interventional
320
2 countries
48
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable heart-failure
Started Aug 2023
Typical duration for not_applicable heart-failure
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2022
CompletedFirst Posted
Study publicly available on registry
January 10, 2023
CompletedStudy Start
First participant enrolled
August 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
June 9, 2026
June 1, 2026
3.4 years
October 7, 2022
June 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Primary Safety Endpoint: Incidence of Aortix Device / Procedural-Related Major Adverse Events (MAE) through 30 days of Follow-up.
Incidence of Major Adverse Events
Baseline to 30 day Follow-Up
Primary Effectiveness Endpoint: Combined composite of clinically significant reduction in net fluid loss over 7 days and freedom from mortality or heart failure re-hospitalization/therapy escalation from the baseline visit to the 30-day follow-up visit.
Composite of net fluid loss, mortality and HF hospitalization/escalation of therapy
Baseline to 30 day Follow-Up
Secondary Outcomes (8)
Net Fluid Loss
Baseline to Day 7
All-cause Mortality
Baseline to 30 day Follow-Up
HF Re-Hospitalization or escalation of HF therapy
Baseline to 30 day Follow-Up
eGFR
Baseline to 30 day Follow-Up
NT-proBNP
Baseline to 30 day Follow-Up
- +3 more secondary outcomes
Study Arms (3)
Treatment Arm
EXPERIMENTALEligible 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. Randomization will be stratified by ejection fraction.
Control Arm
NO INTERVENTIONThe Control arm should receive standard of care therapy as per the study directed Diuretic Care Treatment Algorithm.
Advanced HF Registry
EXPERIMENTALFor the Advanced HF registry, all eligible enrolled subjects will receive Aortix system support.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Currently admitted to the hospital with a primary diagnosis of decompensated heart failure, irrespective of ejection fraction (EF);
- Patients should be on maximally tolerated diuretic therapy and not diuresing sufficiently before being enrolled in DRAIN-HF. After being up-titrated on diuretics, patients should be followed for at least 24 hours on the higher of: i) furosemide 80 mg IV bid or equivalent or ii) IV furosemide or equivalent IV loop diuretic at a dose 2.5 x total daily home dose of furosemide equivalents in 2 divided doses, as tolerated, patient must have: Urine Output \<1,500mL in a 12-hour period OR a Net Fluid Loss ≤375mL in a 12-hour period.
- Age \>21 years and able to provide written informed consent;
- Negative pregnancy test if patient is of child-bearing potential.
You may not qualify if:
- Treatment with high dose IV inotropes within the last 48 hours prior to enrollment. High dose is defined as \>5 µg/kg/min dopamine OR \>5 µg/kg/min dobutamine OR \>0.375 µg/kg/min milrinone;
- Active and ongoing hypotension with a systolic blood pressure \<90 mmHg lasting more than 30 minutes or a mean arterial pressure (MAP) \<60 mmHg lasting more than 30 minutes at enrollment;
- Treatment with vasopressors (defined as phenylephrine, norepinephrine, epinephrine or, vasopressin) within 48 hours prior to enrollment;
- An estimated PASP of \>80 mmHg as measured on echocardiogram or echocardiographic evidence of primarily right heart failure;
- Acute kidney failure defined as an increase in serum creatinine to ≥4.0mg/dL (≥353.6 µmol/L) at enrollment;
- Evidence of contrast induced nephropathy, nephritis or nephrotic syndrome;
- Prior kidney transplant, single kidney, partial nephrectomy OR use of dialysis, continuous renal replacement therapy (CRRT) or ultrafiltration in the last 90 days prior to enrollment;
- Confirmed decompensated cirrhosis (defined as Child Pugh class B or C) or concern for shock liver (AST \> 1000U/L or total Bilirubin \> 5.0mg/dl) at enrollment;
- Presence of an active, uncontrolled infection that would preclude safe placement or removal of the device;
- Prior heart transplant or likely heart transplantation before the 30- day follow-up visit;
- Current or previous support with a durable LVAD at any time or planned LVAD insertion before the 30-day follow-up visit;
- Use of an intra-aortic balloon pump (IABP), extracorporeal membrane oxygenation (ECMO), or percutaneous ventricular assist devices (e.g. Impella or TandemHeart) within the last 30 days;
- Confirmed diagnosis of AL amyloidosis;
- Acute myocardial infarction Type 1 within 30 days of enrollment, or planned coronary revascularization in the next 30 days;
- Stroke within 30 days of enrollment;
- +61 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Procyrionlead
Study Sites (48)
Banner--University Medical Center Phoenix
Phoenix, Arizona, 85006, United States
Mayo Clinic - Arizona
Phoenix, Arizona, 85054, United States
HonorHealth Medical Center
Scottsdale, Arizona, 85258, United States
John Muir Health
Concord, California, 94520, United States
Zuckerberg San Francisco General
San Francisco, California, 94110, United States
San Francisco Veterans Administration
San Francisco, California, 94121, United States
University of California San Francisco
San Francisco, California, 94143, United States
Ascension Sacred Heart
Pensacola, Florida, 32504, United States
Tallahassee Research Institute
Tallahassee, Florida, 32308, United States
University of South Florida
Tampa, Florida, 33606, United States
BayCare Medical/St. Joseph's Hospital
Tampa, Florida, 33607, United States
AdventHealth Tampa
Tampa, Florida, 33613, United States
Cleveland Clinic Florida
Weston, Florida, 33331, United States
Emory University Hospital
Atlanta, Georgia, 30308, United States
Piedmont Healthcare Inc.
Augusta, Georgia, 30309, United States
Wellstar Research Institue
Marietta, Georgia, 30060, United States
University of Chicago
Chicago, Illinois, 60637, United States
Advocate IMMC
Chicago, Illinois, 60657, United States
Advocate Aurora - Good Samaritan
Downers Grove, Illinois, 60515, United States
Ascension via Christi Kansas
Wichita, Kansas, 67226, United States
University of Michigan, Cardiovascular Medicine
Ann Arbor, Michigan, 48109, United States
Henry Ford
Detroit, Michigan, 48202, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753, United States
New York Presbyterian - Brooklyn Methodist Hospital
Brooklyn, New York, 11215, United States
Mount Sinai Morningside
New York, New York, 10025, United States
Nyph/Cumc
New York, New York, 10032, United States
Northwell Health (Lenox Hill)
New York, New York, 10075, United States
Nuvance Health
Poughkeepsie, New York, 12601, United States
Northwell Health (Staten Island)
Staten Island, New York, 10305, United States
Atrium Health Sanger Heart and Vascular Institute
Charlotte, North Carolina, 28204, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Novant Health New Hanover Regional Medical Center
Wilmington, North Carolina, 28401, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Oklahoma Cardiovascular Research Group
Oklahoma City, Oklahoma, 73120, United States
Oregon Health & Sciences University
Portland, Oregon, 97239, United States
Jefferson Abington Hospital
Abington, Pennsylvania, 19001, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
AnMed Health
Anderson, South Carolina, 29621, United States
Baylor Scott & White
Fort Worth, Texas, 76104, United States
Texas Heart Institute
Houston, Texas, 77030, United States
Baylor Scott & White
Plano, Texas, 75093, United States
Intermountain Health
Murray, Utah, 84107, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Virginia Commonwealth University
Richmond, Virginia, 23219, United States
Semmelweis University
Budapest, Hungary
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2022
First Posted
January 10, 2023
Study Start
August 23, 2023
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
August 1, 2027
Last Updated
June 9, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share