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New treatment option for Heart Failure
Official title Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure
ClinicalTrials.gov ID: NCT05677100
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join if
- (assigned by chance Study):
- 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...
- Persistent signs and/or symptoms of congestion as evidenced by at least 2+ pitting edema, elevated jugular venous pressure \>12 cm water or ascites...
- Age \>21 years and able to provide written informed consent;
You likely can't join if
- (assigned by chance 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...
- Active and ongoing hypotension with a systolic blood pressure \<90 mmHg lasting more than 30 minutes or a mean arterial pressure (MAP) \<60 mmHg...
- 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;
See the full eligibility criteria
Who can join
- (assigned by chance Study):
- 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...
- 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.
What rules you out
- (assigned by chance 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;
- 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;
- 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 [\ 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...
- 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...
- 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. Inclusion Criteria (Advanced Heart Failure Registry):
- Currently admitted to the hospital with a primary diagnosis of decompensated HF, irrespective of ejection fraction (EF).
- 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...
- 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...
- 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. Exclusion Criteria (Advanced Heart Failure Registry):
- 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 [\ 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- Concord, California, United States
- San Francisco, California, United States
- Pensacola, Florida, United States
- Tallahassee, Florida, United States
- Tampa, Florida, United States
- Weston, Florida, United States
- Atlanta, Georgia, United States
- Augusta, Georgia, United States
- Marietta, Georgia, United States
- Chicago, Illinois, United States
- Downers Grove, Illinois, United States
- Elk Grove Village, Illinois, United States
- Wichita, Kansas, United States
- Ann Arbor, Michigan, United States
- Detroit, Michigan, United States
- Jackson, Mississippi, United States
- Hackensack, New Jersey, United States
- Neptune City, New Jersey, United States
+ 20 more site(s).
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Scottsdale, Arizona, United States; Concord, California, United States; San Francisco, California, United States; Pensacola, Florida, United States; Tallahassee, Florida, United States and 34 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.