The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05677100
Recruitment Status : Recruiting
First Posted : January 10, 2023
Last Update Posted : June 5, 2024
Sponsor:
Information provided by (Responsible Party):
Procyrion

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 are resistant to diuretic 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.


Condition or disease Intervention/treatment Phase
Heart Failure Cardiorenal Syndrome Cardio-Renal Syndrome ADHF Heart Failure, Systolic Heart Failure, Diastolic Heart Failure; With Decompensation Heart Failure, Congestive Device: Aortix System Not Applicable

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 268 subjects with heart failure at 45 clinical sites in the United States. The randomized study includes up to 188 subjects and the Advanced HF registry includes up to 80 subjects.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 268 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The patients will be randomized 1:1 and will be receiving their treatment in parallel to each other. An additional non-randomized registry is also included
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: DRAIN-HF: Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure
Actual Study Start Date : August 23, 2023
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Treatment Arm
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.
Device: Aortix 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.
Other Name: Aortix Pump

No Intervention: Control Arm
The Control arm should receive standard of care therapy as per the study directed Diuretic Care Treatment Algorithm.
Experimental: Advanced HF Registry
For the Advanced HF registry, all eligible enrolled subjects will receive Aortix system support.
Device: Aortix 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.
Other Name: Aortix Pump




Primary Outcome Measures :
  1. 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 ]
    Incidence of Major Adverse Events

  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. [ Time Frame: Baseline to 30 day Follow-Up ]
    Composite of net fluid loss, mortality and HF hospitalization/escalation of therapy


Secondary Outcome Measures :
  1. Net Fluid Loss [ Time Frame: Baseline to Day 7 ]
    Change in Net Fluid Loss from Baseline to Day 7/Discharge

  2. All-cause Mortality [ Time Frame: Baseline to 30 day Follow-Up ]
    Rate of mortality

  3. HF Re-Hospitalization or escalation of HF therapy [ Time Frame: Baseline to 30 day Follow-Up ]
    Evaluation of HF re-hospitalization and therapy escalation

  4. eGFR [ Time Frame: Baseline to 30 day Follow-Up ]
    Evaluation of changes in eGFR

  5. NT-proBNP [ Time Frame: Baseline to 30 day Follow-Up ]
    Evaluation of NT-proBNP

  6. Patient Reported Dyspnea Assessment [ Time Frame: Baseline to 30 day Follow-Up ]
    Change in patient reported dyspnea scale

  7. Standing body weight [ Time Frame: Baseline to 30 day Follow-Up ]
    Change in standing body weight

  8. Incidence and percentages of major adverse events (MAE) Pooled [ Time Frame: Baseline to 30 day Follow-Up ]
    Incidence and percentages of major adverse events (MAE) pooled analysis of Aortix randomized cohort and registry cohort



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria (Randomized Study):

  • Currently admitted to the hospital with a primary diagnosis of decompensated heart failure, irrespective of ejection fraction (EF);
  • Urine output for 12 hours prior to enrollment is < 1500 ml following at least 48 hours of 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;
  • Persistent signs and/or symptoms of congestion as evidenced by at least 2+ pitting edema 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.

Exclusion Criteria (Randomized Study):

  • Treatment with high dose IV inotropes within the last 48 hours. 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;
  • Treatment with vasopressors (defined as phenylephrine, norepinephrine, epinephrine or, vasopressin) within 48 hours of enrollment;
  • An estimated PASP of >80 mmHg as measured on echocardiogram or echocardiographic evidence of primarily right heart failure;
  • Treatment with IV diuretics (does not have to be continuous) for ≥21 days during the current hospitalization (including time spent at an outside hospital);
  • Acute kidney failure defined as an increase in serum creatinine to ≥4.0mg/dL (≥353.6 µmol/L) within the last 48 hours before enrollment;
  • Evidence of contrast induced nephropathy, nephritis or nephrotic syndrome;
  • Prior kidney transplant, single kidney, partial nephrectomy, stage V chronic kidney disease (eGFR <18) at admission OR use of dialysis, continuous renal replacement therapy (CRRT) or ultrafiltration in the last 90 days;
  • Confirmed cirrhosis or concern for shock liver (AST > 1000U/L or total Bilirubin > 5.0mg/dl);
  • 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;
  • Known amyloidosis of any type;
  • 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):

    1. 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,
    2. GI bleeding within 6 months requiring hospitalization and/or transfusion,
    3. Recent major surgery within 30 days if the surgical wound is judged to be associated with an increased risk of bleeding,
    4. Procedure with arterial ilio-femoral access > 6 FR within 30 days,
    5. Platelet count <75,000 cells/mm3,
    6. Uncorrectable bleeding diathesis or coagulopathy (e.g. INR ≥2 not due to anticoagulation therapy) or hypercoaguable state including HIT;
    7. Inability to tolerate anticoagulation therapy for up to 7 days.
  • Contraindicated Anatomy :

    1. 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)],
    2. Ilio-femoral diameter or peripheral vascular anatomy that would preclude safe placement of a 21F (outer diameter) introducer sheath,
    3. Femoral artery depth inconsistent with use of closure device,
    4. 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),
    5. Known connective tissue disorder (e.g. Marfan Syndrome) or other aortopathy at risk of vascular injury,
    6. Current endovascular stent graft in the descending aorta or any femoro-iliac vessels;
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05677100


Contacts
Layout table for location contacts
Contact: Rubi Reyes-Fuentez 832-536-1601 rubi@procyrion.com

Locations
Show Show 34 study locations
Sponsors and Collaborators
Procyrion
Layout table for additonal information
Responsible Party: Procyrion
ClinicalTrials.gov Identifier: NCT05677100    
Other Study ID Numbers: CSP001
First Posted: January 10, 2023    Key Record Dates
Last Update Posted: June 5, 2024
Last Verified: June 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Procyrion:
mechanical circulatory support
percutaneous
Additional relevant MeSH terms:
Layout table for MeSH terms
Cardio-Renal Syndrome
Heart Failure
Heart Failure, Systolic
Heart Failure, Diastolic
Syndrome
Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases