Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure

Heart Failure Clinical Trial

— DRAIN-HF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05677100
• Other study ID #: CSP001
• Status: Recruiting
• Phase: N/A
• Start date: August 23, 2023
• Est. completion date: December 2025

Study information

• Verified date: June 2024
• Source: Procyrion
• Contact: Rubi Reyes-Fuentez
• Phone: 832-536-1601
• Email: rubi[@]procyrion.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 268
• Est. completion date: December 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• ADHF
• Cardio-Renal Syndrome
• Cardiorenal Syndrome
• Heart Failure
• Heart Failure, Congestive
• Heart Failure, Diastolic
• Heart Failure, Systolic
• Heart Failure; With Decompensation
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	Jefferson Abington Hospital	Abington	Pennsylvania
United States	Lehigh Valley Hospital	Allentown	Pennsylvania
United States	University of Michigan, Cardiovascular Medicine	Ann Arbor	Michigan
United States	Emory University Hospital	Atlanta	Georgia
United States	Piedmont Healthcare Inc.	Augusta	Georgia
United States	University of North Carolina Medical Center	Chapel Hill	North Carolina
United States	Atrium Health Sanger Heart and Vascular Institute	Charlotte	North Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	Advocate IMMC	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	The Ohio State University	Columbus	Ohio
United States	John Muir Health	Concord	California
United States	Henry Ford	Detroit	Michigan
United States	Advocate Aurora - Good Samaritan	Downers Grove	Illinois
United States	Duke University Medical Center	Durham	North Carolina
United States	Baylor Scott & White Research Institute	Fort Worth	Texas
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Wellstar Research Institue	Marietta	Georgia
United States	Jersey Shore University Medical Center	Neptune	New Jersey
United States	Mount Sinai Morningside	New York	New York
United States	Northwell Health (Lenox Hill)	New York	New York
United States	Nyph/Cumc	New York	New York
United States	Oklahoma Cardiovascular Research Group	Oklahoma City	Oklahoma
United States	Penn Presbyterian Medical Center	Philadelphia	Pennsylvania
United States	Nuvance Health	Poughkeepsie	New York
United States	San Francisco Veterans Administration	San Francisco	California
United States	University of California San Francisco	San Francisco	California
United States	Zuckerberg San Francisco General	San Francisco	California
United States	HonorHealth Medical Center	Scottsdale	Arizona
United States	Northwell Health (Staten Island)	Staten Island	New York
United States	AdventHealth Tampa	Tampa	Florida
United States	University of South Florida	Tampa	Florida
United States	Cleveland Clinic Florida	Weston	Florida
United States	Cardiovascular Research Institute of Kansas	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Procyrion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Safety Endpoint: Incidence of Aortix Device / Procedural-Related Major Adverse Events (MAE) through 30 days of Follow-up.	Incidence of Major Adverse Events	Baseline to 30 day Follow-Up
Primary	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	Baseline to 30 day Follow-Up
Secondary	Net Fluid Loss	Change in Net Fluid Loss from Baseline to Day 7/Discharge	Baseline to Day 7
Secondary	All-cause Mortality	Rate of mortality	Baseline to 30 day Follow-Up
Secondary	HF Re-Hospitalization or escalation of HF therapy	Evaluation of HF re-hospitalization and therapy escalation	Baseline to 30 day Follow-Up
Secondary	eGFR	Evaluation of changes in eGFR	Baseline to 30 day Follow-Up
Secondary	NT-proBNP	Evaluation of NT-proBNP	Baseline to 30 day Follow-Up
Secondary	Patient Reported Dyspnea Assessment	Change in patient reported dyspnea scale	Baseline to 30 day Follow-Up
Secondary	Standing body weight	Change in standing body weight	Baseline to 30 day Follow-Up
Secondary	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	Baseline to 30 day Follow-Up