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

Primary Purpose

Heart Failure, Cardiorenal Syndrome, Cardio-Renal Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aortix System
Sponsored by
Procyrion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring mechanical circulatory support, percutaneous

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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): 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, 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.

Sites / Locations

  • Cardiovascular Research Institute of KansasRecruiting
  • Henry FordRecruiting
  • Mount Sinai MorningsideRecruiting
  • Oklahoma Cardiovascular Research GroupRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Experimental

Arm Label

Treatment Arm

Control Arm

Advanced HF Registry

Arm 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.

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

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

Outcomes

Primary Outcome Measures

Primary Safety Endpoint: Incidence of Aortix Device / Procedural-Related Major Adverse Events (MAE) through 30 days of 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.
Composite of net fluid loss, mortality and HF hospitalization/escalation of therapy

Secondary Outcome Measures

Net Fluid Loss
Change in Net Fluid Loss from Baseline to Day 7/Discharge
All-cause Mortality
Rate of mortality
HF Re-Hospitalization or escalation of HF therapy
Evaluation of HF re-hospitalization and therapy escalation
eGFR
Evaluation of changes in eGFR
NT-proBNP
Evaluation of NT-proBNP
Patient Reported Dyspnea Assessment
Change in patient reported dyspnea scale
Standing body weight
Change in standing body weight
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

Full Information

First Posted
October 7, 2022
Last Updated
October 16, 2023
Sponsor
Procyrion
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1. Study Identification

Unique Protocol Identification Number
NCT05677100
Brief Title
Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure
Acronym
DRAIN-HF
Official Title
DRAIN-HF: Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 23, 2023 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Procyrion

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Cardiorenal Syndrome, Cardio-Renal Syndrome, ADHF, Heart Failure, Systolic, Heart Failure, Diastolic, Heart Failure; With Decompensation, Heart Failure, Congestive
Keywords
mechanical circulatory support, percutaneous

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
268 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Experimental
Arm 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.
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
The Control arm should receive standard of care therapy as per the study directed Diuretic Care Treatment Algorithm.
Arm Title
Advanced HF Registry
Arm Type
Experimental
Arm Description
For the Advanced HF registry, all eligible enrolled subjects will receive Aortix system support.
Intervention Type
Device
Intervention Name(s)
Aortix System
Other Intervention Name(s)
Aortix Pump
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary Safety Endpoint: Incidence of Aortix Device / Procedural-Related Major Adverse Events (MAE) through 30 days of Follow-up.
Description
Incidence of Major Adverse Events
Time Frame
Baseline to 30 day Follow-Up
Title
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.
Description
Composite of net fluid loss, mortality and HF hospitalization/escalation of therapy
Time Frame
Baseline to 30 day Follow-Up
Secondary Outcome Measure Information:
Title
Net Fluid Loss
Description
Change in Net Fluid Loss from Baseline to Day 7/Discharge
Time Frame
Baseline to Day 7
Title
All-cause Mortality
Description
Rate of mortality
Time Frame
Baseline to 30 day Follow-Up
Title
HF Re-Hospitalization or escalation of HF therapy
Description
Evaluation of HF re-hospitalization and therapy escalation
Time Frame
Baseline to 30 day Follow-Up
Title
eGFR
Description
Evaluation of changes in eGFR
Time Frame
Baseline to 30 day Follow-Up
Title
NT-proBNP
Description
Evaluation of NT-proBNP
Time Frame
Baseline to 30 day Follow-Up
Title
Patient Reported Dyspnea Assessment
Description
Change in patient reported dyspnea scale
Time Frame
Baseline to 30 day Follow-Up
Title
Standing body weight
Description
Change in standing body weight
Time Frame
Baseline to 30 day Follow-Up
Title
Incidence and percentages of major adverse events (MAE) Pooled
Description
Incidence and percentages of major adverse events (MAE) pooled analysis of Aortix randomized cohort and registry cohort
Time Frame
Baseline to 30 day Follow-Up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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): 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, 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rubi Reyes-Fuentez
Phone
832-536-1601
Email
rubi@procyrion.com
Facility Information:
Facility Name
Cardiovascular Research Institute of Kansas
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meredith Thunberg, RN
First Name & Middle Initial & Last Name & Degree
Bassem Chehab, MD
Facility Name
Henry Ford
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelsey Neaton
Facility Name
Mount Sinai Morningside
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathy Idrissi
Facility Name
Oklahoma Cardiovascular Research Group
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donna Grossman, RN
First Name & Middle Initial & Last Name & Degree
Mohammad Ghani, MD
First Name & Middle Initial & Last Name & Degree
Pamela Craven, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure

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