DRAIN-HF: Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure
Overview
- Phase
- Not Applicable
- Intervention
- Aortix System
- Conditions
- Not specified
- Sponsor
- Procyrion
- Enrollment
- 320
- Locations
- 91
- Primary Endpoint
- Primary Safety Endpoint: Incidence of Aortix Device / Procedural-Related Major Adverse Events (MAE) through 30 days of Follow-up.
- Status
- Recruiting
- Last Updated
- last month
Overview
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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(Randomized 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 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;
- •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;
Arms & Interventions
Advanced HF Registry
For the Advanced HF registry, all eligible enrolled subjects will receive Aortix system support.
Intervention: Aortix System
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.
Intervention: Aortix System
Control Arm
The Control arm should receive standard of care therapy as per the study directed Diuretic Care Treatment Algorithm.
Outcomes
Primary Outcomes
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
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 Outcomes
- eGFR(Baseline to 30 day Follow-Up)
- NT-proBNP(Baseline to 30 day Follow-Up)
- Incidence and percentages of major adverse events (MAE) Pooled(Baseline to 30 day Follow-Up)
- All-cause Mortality(Baseline to 30 day Follow-Up)
- Patient Reported Dyspnea Assessment(Baseline to 30 day Follow-Up)
- Standing body weight(Baseline to 30 day Follow-Up)
- Net Fluid Loss(Baseline to Day 7)
- HF Re-Hospitalization or escalation of HF therapy(Baseline to 30 day Follow-Up)