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

Procyrion

Status: Enrolling

Conditions: ADHF; Heart Failure, Diastolic; Heart Failure, Systolic; Cardiorenal Syndrome; Heart Failure; with Decompensation; Heart Failure, Congestive; Cardio-Renal Syndrome; Heart Failure

Treatments: Device: Aortix System

Study type: Interventional

Funder types: Industry

Identifiers

NCT05677100

CSP001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 268 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (Randomized Study):

• Currently admitted to the hospital with a primary diagnosis of decompensated heart failure, irrespective of ejection fraction (EF);
• 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, 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.

Exclusion Criteria (Randomized Study):

• 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;

• 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) at 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 enrollment 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;

• 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. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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268 participants in 3 patient groups

Treatment Arm

Experimental group

Description:

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.

Treatment:

Device: Aortix System

Control Arm

No Intervention group

Description:

The Control arm should receive standard of care therapy as per the study directed Diuretic Care Treatment Algorithm.

Advanced HF Registry

Experimental group

Description:

For the Advanced HF registry, all eligible enrolled subjects will receive Aortix system support.

Treatment:

Device: Aortix System