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Heart FailureDRAIN-HFNCT05677100

Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure

A study testing Aortix System in people with Heart Failure and Cardiorenal Syndrome, run by Procyrion at 50 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 21 years and older
What is being tested?
Aortix System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
320 participants
Where
50 sitesin 2 countries
Study dates
23 Aug 2023to Aug 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Persistent signs and/or symptoms of congestion as evidenced by at least 2+ pitting edema, elevated jugular venous pressure >12 cm water or ascites after treatment with IV diuretics per inclusion criterion 2.;
  • Age >21 years and able to provide written informed consent;
  • Negative pregnancy test if patient is of child-bearing potential.
  • Currently admitted to the hospital with a primary diagnosis of decompensated HF, irrespective of ejection fraction (EF).
Show all 12Show fewer
  • Patient has already been evaluated and indicated to receive an LVAD or heart transplant and will receive the LVAD or be listed for heart transplantation in the next 30 days if their congestion status and renal function improves.
  • Patient must have been treated with ≥ 80 mg IV furosemide bid or equivalent and have evidence of increasing diuretic dosing requirements over the past 12 months, as tolerated.
  • Must have evidence of refractoriness to medical management as documented by persistent signs and/or symptoms of congestion as evidenced by at least 2+ pitting edema, elevated jugular venous pressure >12 cm water, or ascites after treatment with IV diuretics for a minimum of 24 hours.
  • Serum creatinine ≥ 2.0 mg/dL AND eGFR ≤ 45 ml/min/1.73m2 at time of enrollment
  • Age ≥ 21 years and able to provide written informed consent.
  • Negative pregnancy test if patient is of childbearing potential.

Who cannot join

  • 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;
Show all 69Show fewer
  • 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;
  • Severe Bleeding Risk (any of the following):
  • Previous intracranial bleed unless there is documentation in the medical record (from a physician that is not part of the study) that the patient can safely use anticoagulation for 7 days,
  • GI bleeding within 6 months requiring hospitalization and/or transfusion,
  • Recent major surgery within 30 days if the surgical wound is judged to be associated with an increased risk of bleeding,
  • Procedure with arterial ilio-femoral access > 6 FR within 30 days,
  • Platelet count <75,000 cells/mm3,
  • Uncorrectable bleeding diathesis or coagulopathy (e.g. INR ≥2 not due to anticoagulation therapy) or hypercoaguable state including HIT;
  • Inability to tolerate anticoagulation therapy for up to 7 days.
  • Contraindicated Anatomy :
  • Descending aortic anatomy that would prevent safe placement of the device [<18 mm or >31 mm aorta diameter at deployment location (measured between the superior aspect of the T10 vertebra and superior aspect of the L1 vertebra)],
  • Ilio-femoral diameter or peripheral vascular anatomy that would preclude safe placement of a 21F (outer diameter) introducer sheath,
  • Femoral artery depth inconsistent with use of closure device,
  • Abnormalities or severe vascular disease that would preclude safe access and device delivery (e.g. aneurysm with thrombus, marked tortuosity, significant narrowing or inadequate size of the abdominal aorta, iliac or femoral arteries, or severe calcification),
  • Known connective tissue disorder (e.g. Marfan Syndrome) or other aortopathy at risk of vascular injury,
  • Any endovascular stent graft in the descending aorta. Any endovascular stent graft in the femoro-iliac vessels that is not well endothelialized and would preclude safe introduction/removal of the Aortix pump as demonstrated by imaging.
  • Known hypersensitivity or contraindication to study or procedure medications (e.g. anticoagulation therapy) or device materials (e.g. history of severe reaction to nickel or nitinol);
  • Participation in any other clinical investigation that is likely to confound study results or affect the study;
  • Poor health such that the patient is unable to undergo the Aortix device placement/retrieval and/or unlikely to be able to survive to the 30-day visit;
  • Unable or unwilling to undergo screening (imaging, PA Catheter placement), device implant and retrieval procedures or return for 30-day visit.
  • Treatment with high dose IV inotropes within 48 hours prior to enrollment. High dose is defined as any one of the following: >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 <80 mmHg lasting more than 30 minutes or a mean arterial pressure (MAP) <55 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 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.
  • Current or previous support with a durable LVAD.
  • INTERMACS Profile 1 at enrollment.
  • Currently on mechanical ventilatory support.
  • Use of an extracorporeal membrane oxygenation (ECMO) or percutaneous ventricular assist device (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.
  • Severe Bleeding Risk (any of the following):
  • Previous intracranial bleed unless there is documentation in the medical record (from a physician that is not part of the study) that the patient can safely use anticoagulation for 7 days.
  • GI bleeding within 6 months requiring hospitalization and/or transfusion.
  • Recent major surgery within 30 days if the surgical wound is judged to be associated with an increased risk of bleeding.
  • Procedure with arterial ilio-femoral access > 6 Fr within 30 days.
  • Platelet count <75,000 cells/mm3 .
  • Uncorrectable bleeding diathesis or coagulopathy (e.g., INR≥ 2 not due to anticoagulation therapy) or hypercoagulable state including HIT.
  • Inability to tolerate anticoagulation therapy for up to 7 days.
  • Contraindicated Anatomy :
  • Descending aortic anatomy that would prevent safe placement of the device [<18 mm or >31 mm aorta diameter at deployment location (measured between the superior aspect of the T10 vertebra and superior aspect of the L1 vertebra)].
  • Ilio-femoral diameter or peripheral vascular anatomy that would preclude safe placement of a 21 Fr (outer diameter) introducer sheath.
  • Femoral artery depth inconsistent with use of closure device.
  • Abnormalities or severe vascular disease that would preclude safe access and device delivery (e.g., aneurysm with thrombus; marked tortuosity; significant narrowing or inadequate size of the abdominal aorta, iliac, or femoral arteries; or severe calcification).
  • Known connective tissue disorder (e.g., Marfan Syndrome) or other aortopathy at risk of vascular injury.
  • Any endovascular stent graft in the descending aorta. Any endovascular stent graft in the femoro-iliac vessels that is not well endothelialized and would preclude safe introduction/removal of the Aortix pump as demonstrated by imaging.
  • Known hypersensitivity or contraindication to study or procedure medications (e.g., anticoagulation therapy) or device materials (e.g., history of severe reaction to nickel or nitinol).
  • Participation in any other clinical investigation that is likely to confound study results or affect the study.
  • Poor health such that the patient is unable to undergo the Aortix device placement/retrieval and/or unlikely to be able to survive to the 30-day visit.
  • Unable or unwilling to undergo screening, device implant and retrieval procedures, or return for 30-day visit.

Trial locations and contacts

50 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Rubi Reyes-Fuentez contact

832-536-1601

rubi@procyrion.com

50 sites in 2 countries

United States49 sites, 32 recruiting

  • Jefferson Abington Hospital

    Abington, Pennsylvania, 19001

    Colleen Marchand

    Alexander Shpilman, MD

    Recruiting

  • AnMed Health

    Anderson, South Carolina, 29621

    Jennifer Lee

    Recruiting

  • University of Michigan, Cardiovascular Medicine

    Ann Arbor, Michigan, 48109

    Withdrawn

  • Emory University Hospital

    Atlanta, Georgia, 30308

    Wei Xu

    Chandan Devireddy, MD

    Recruiting

  • Piedmont Healthcare Inc.

    Augusta, Georgia, 30309

    Jennifer Hansen

    Darshak Karia, MD

    Recruiting

  • New York Presbyterian - Brooklyn Methodist Hospital

    Brooklyn, New York, 11215

    Jhane Phanor, jhp4004@nyp.org

    Kumudha Ramasubbu

    Recruiting

  • Atrium Health Sanger Heart and Vascular Institute

    Charlotte, North Carolina, 28204

    Krystal Winkler

    Recruiting

  • University of Virginia

    Charlottesville, Virginia, 22908

    Terminated

  • University of Chicago

    Chicago, Illinois, 60637

    Ransford Botchey

    Jonathan Grinstein, MD

    Recruiting

  • Advocate IMMC

    Chicago, Illinois, 60657

    Maci Eiber

    Recruiting

  • The Ohio State University

    Columbus, Ohio, 43210

    Diane Burke

    Recruiting

  • John Muir Health

    Concord, California, 94520

    Rita Trachuk

    Recruiting

  • Henry Ford

    Detroit, Michigan, 48202

    Kelsey Neaton

    Recruiting

  • Advocate Aurora - Good Samaritan

    Downers Grove, Illinois, 60515

    Terminated

  • Duke University Medical Center

    Durham, North Carolina, 27710

    Active, not recruiting

  • Ascenscion Alexian Brothers

    Elk Grove Village, Illinois, 60007

    Jeanine Pilat

    Recruiting

  • Broward Health

    Fort Lauderdale, Florida, 33316

    Laura Hudson

    Recruiting

  • Baylor Scott & White

    Fort Worth, Texas, 76104

    Withdrawn

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

    Stephanie Lynes

    Recruiting

  • Texas Heart Institute

    Houston, Texas, 77030

    Jeanine Bacani

    Joggy George, MD

    Recruiting

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

    Memrie Cochran

    Recruiting

  • Wellstar Research Institue

    Marietta, Georgia, 30060

    Terminated

  • Intermountain Health

    Murray, Utah, 84107

    Withdrawn

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753

    Anne DeToro

    Recruiting

  • Mount Sinai Morningside

    New York, New York, 10025

    Kathy Idrissi

    Recruiting

  • Nyph/Cumc

    New York, New York, 10032

    Barbara Alvarez

    Recruiting

  • Northwell Health (Lenox Hill)

    New York, New York, 10075

    Terminated

  • Oklahoma Cardiovascular Research Group

    Oklahoma City, Oklahoma, 73120

    Katie Kennedy

    Recruiting

  • Ascension Sacred Heart

    Pensacola, Florida, 32504

    Withdrawn

  • Penn Presbyterian Medical Center

    Philadelphia, Pennsylvania, 19104

    Margaret Bussineau

    Recruiting

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

    Withdrawn

  • Banner--University Medical Center Phoenix

    Phoenix, Arizona, 85006

    Abisola Akinbobola, MSc

    I-Hui Chiang, M.D.

    Recruiting

  • Mayo Clinic - Arizona

    Phoenix, Arizona, 85054

    Erica Boyd, 480-342-3484, boyd.erica@mayo.edu

    David Fortuin, M.D.

    Recruiting

  • Baylor Scott & White

    Plano, Texas, 75093

    Withdrawn

  • Oregon Health & Sciences University

    Portland, Oregon, 97239

    Active, not recruiting

  • Nuvance Health

    Poughkeepsie, New York, 12601

    Tricia Landi

    Recruiting

  • Virginia Commonwealth University

    Richmond, Virginia, 23219

    Melissa Sears

    Recruiting

  • Zuckerberg San Francisco General

    San Francisco, California, 94110

    Katherine Steineman

    Lucas Zier, MD

    Recruiting

  • San Francisco Veterans Administration

    San Francisco, California, 94121

    Terminated

  • University of California San Francisco

    San Francisco, California, 94143

    Cherry Ng

    Recruiting

  • HonorHealth Medical Center

    Scottsdale, Arizona, 85258

    Terminated

  • Northwell Health (Staten Island)

    Staten Island, New York, 10305

    Sammi Ruan

    Recruiting

  • Tallahassee Research Institute

    Tallahassee, Florida, 32308

    Terminated

  • University of South Florida

    Tampa, Florida, 33606

    Mia Eifrid

    Robby Wu, MD

    Recruiting

  • BayCare Medical/St. Joseph's Hospital

    Tampa, Florida, 33607

    Nirav Raval, MD, 813-397-1251

    Alok Singh, MD

    Recruiting

  • AdventHealth Tampa

    Tampa, Florida, 33613

    Cynthia Paysor, LPN

    Oliver Abela, MD

    Recruiting

  • Cleveland Clinic Florida

    Weston, Florida, 33331

    Juan Armijos

    Steve Minear, MD

    Recruiting

  • Ascension via Christi Kansas

    Wichita, Kansas, 67226

    Terminated

  • Novant Health New Hanover Regional Medical Center

    Wilmington, North Carolina, 28401

    Withdrawn

Other trials in United States

Hungary1 site, 1 recruiting

  • Semmelweis University

    Budapest

    Laura Kosa-Hobor, 0036 20 825 0511, hobor.laura@semmelweis.hu

    Bela Merkely, MD

    Recruiting

Other trials in Hungary

About this study

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

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.

Read the detailed description

The study is a prospective, multi-center, randomized, nonblinded study to evaluate the safety and effectiveness of the Aortix System versus standard of care medical therapy in patients hospitalized with acute decompensated heart failure (ADHF) and persistent congestion despite usual medical management.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. Randomization will be stratified by ejection fraction..

An additional registry arm will enroll patients who are considered candidates for advanced therapies in the near-term, but need improvement in their renal function to be able to receive additional medical therapies. All eligible enrolled registry subjects will receive Aortix system support.

Planned study population is male or female patients 21 years of age or greater, with acute decompensated heart failure and diuretic resistance who remain congested despite standard of care medical therapy.

This study will enroll up to 320 subjects with heart failure at 50 clinical sites in the United States and up to 5 OUS sites. The randomized study includes up to 240 subjects and the Advanced HF registry includes up to 80 subjects.

Being tested
Aortix System
Keywords
mechanical circulatory support, percutaneous
Medical subject headings
Heart Failure, Cardio-Renal Syndrome, Heart Failure, Systolic, Heart Failure, Diastolic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aortix SystemDevice

    Also called Aortix Pump

    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.

Study groups in NCT05677100
Study groupRoleWhat they receive
Treatment ArmExperimentalEligible ADHF patients with diuretic resistance (irrespective of ejection fraction) will be enrolled and randomized 2:1 to either the Aortix system or standard of care medical management. Randomization will be stratified by ejection fraction.
Receives: Device: Aortix System
Control ArmNo interventionThe Control arm should receive standard of care therapy as per the study directed Diuretic Care Treatment Algorithm.
Advanced HF RegistryExperimentalFor the Advanced HF registry, all eligible enrolled subjects will receive Aortix system support.
Receives: Device: Aortix System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Safety Endpoint: Incidence of Aortix Device / Procedural-Related Major Adverse Events (MAE) through 30 days of Follow-up.

    Incidence of Major Adverse Events

    Measured: Baseline to 30 day Follow-Up

  2. 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

    Measured: Baseline to 30 day Follow-Up

Secondary outcomes (8)

  1. Net Fluid Loss

    Change in Net Fluid Loss from Baseline to Day 7/Discharge

    Measured: Baseline to Day 7

  2. All-cause Mortality

    Rate of mortality

    Measured: Baseline to 30 day Follow-Up

  3. HF Re-Hospitalization or escalation of HF therapy

    Evaluation of HF re-hospitalization and therapy escalation

    Measured: Baseline to 30 day Follow-Up

  4. eGFR

    Evaluation of changes in eGFR

    Measured: Baseline to 30 day Follow-Up

  5. NT-proBNP

    Evaluation of NT-proBNP

    Measured: Baseline to 30 day Follow-Up

  6. Patient Reported Dyspnea Assessment

    Change in patient reported dyspnea scale

    Measured: Baseline to 30 day Follow-Up

  7. Standing body weight

    Change in standing body weight

    Measured: Baseline to 30 day Follow-Up

  8. Incidence and percentages of major adverse events (MAE) Pooled

    Incidence and percentages of major adverse events (MAE) pooled analysis of Aortix randomized cohort and registry cohort

    Measured: Baseline to 30 day Follow-Up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2023
  2. Study start23 Aug 2023
  3. Primary completionJan 2028 (estimated)
  4. Study completionAug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The patients will be randomized 2:1 and will be receiving their treatment in parallel to each other. An additional non-randomized registry is also included
Masking
None (open label)
Enrolment
320 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05677100
Sponsor's protocol ID
CSP001
Acronym
DRAIN-HF
Status last verified
Aug 2026
First submitted
7 Oct 2022
Last updated
25 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Aortix System in people with Heart Failure and Cardiorenal Syndrome, run by Procyrion at 50 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 69 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in United States, Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rubi Reyes-Fuentez (832-536-1601, rubi@procyrion.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Safety Endpoint: Incidence of Aortix Device / Procedural-Related Major Adverse Events (MAE) through 30 days of Follow-up. (time frame: Baseline to 30 day Follow-Up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05677100.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.

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