NCT05677100ClinicalTrials.gov

Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure

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

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En resumen

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…

De intervención320 participantes buscados50 centros2 países

Categorías

Cardiovascular84%Nefrología y urología13%Obstetricia y ginecología3%

Registrado en 1 registro

ClinicalTrials.govNCT05677100Abrir este registro en ClinicalTrials.govSincronizado hace 4 semanas

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2023-01-10; recorded start 2023-08-23
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Not stated: Open label (no blinding)Masking is recorded as none (open label)
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Not stated: No other studies from this sponsor are in this databaseCounted from the lead sponsor named in the record (Procyrion)
Not stated: No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database

The record lists 8 conditions.
Lead sponsor type recorded as: industry.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourMODERATE

A moderately rigorous design for a study of this type, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation20/20
Participants are randomly allocated between arms
Blinding0/20
Open-label
Control arm0/15
No comparator arm stated in the record
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
Multi-centre8/8
Multi-centre: 49 sites
Data monitoring committee7/7
A data monitoring committee is in place
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleMEDIUM

A medium-sized study, international in scope: 320 participants (target), run at 50 sites, across 2 countries.

How this score is built

Enrolment24/40
320 participants (target)
Site count20/25
49 sites
Country count7/15
2 countries
Planned duration9/10
Planned over about 48 months
Sponsor scale0/10
Procyrion has led 1 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Resumen

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.

Afecciones

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

Elegibilidad

Elegibilidad
Sexo	Todos
Edades	21 Years – Sin máximo
Voluntarios sanos	No

Elegibilidad tal como figura en el registro

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; * 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): 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. 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 improves. * 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 ascites after treatment with IV diuretics for a minimum of 24 hours. * 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 \[\<18 mm or \>31 mm aorta diameter at deployment location (measured between the superior aspect of the T10 vertebra and superior aspect of the L1 vertebra)\]. * Ilio-femoral diameter or peripheral vascular anatomy that would preclude safe placement of a 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 femoral arteries; or severe calcification). * 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 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, device implant and retrieval procedures, or return for 30-day visit.

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Diseño del estudio
Tipo de estudio	De intervención
Fase	No aplicable
Asignación	Aleatorizado
Modelo de intervención	PARALLEL
Propósito principal	TREATMENT
Enmascaramiento	NONE (0)
Inscripción	320 participantes buscados

Patrocinador y colaboradores

Procyrion Patrocinador

Grupos e intervenciones

Treatment ArmEXPERIMENTAL
Eligible ADHF patients with diuretic resistance (irrespective of ejection fraction) will be enrolled and randomized 2:1 to either the Aortix system or standard of care medical management. Randomization will be stratified by ejection fraction.
Control ArmNO_INTERVENTION
The Control arm should receive standard of care therapy as per the study directed Diuretic Care Treatment Algorithm.
Advanced HF RegistryEXPERIMENTAL
For the Advanced HF registry, all eligible enrolled subjects will receive Aortix system support.

Intervenciones

Dispositivo 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.

Variables de resultado

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

Fechas

Fechas
Fecha de inicio	23 de agosto de 2023 (real)
Finalización principal	1 de enero de 2028 (estimada)
Finalización	1 de agosto de 2028 (estimada)
Primera publicación	10 de enero de 2023 (real)
Última actualización	25 de agosto de 2026
Resultados publicados	No indicado en el registro
Estado verificado por última vez	agosto de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

33 centros están en reclutamiento

Hungary

Hungary
Centro	Ciudad	Estado o región	Estado
Semmelweis University	Budapest		En reclutamiento

United States

United States
Centro	Ciudad	Estado o región	Estado
Jefferson Abington Hospital	Abington	Pennsylvania	En reclutamiento
AnMed Health	Anderson	South Carolina	En reclutamiento
University of Michigan, Cardiovascular Medicine	Ann Arbor	Michigan	Retirado
Emory University Hospital	Atlanta	Georgia	En reclutamiento
Piedmont Healthcare Inc.	Augusta	Georgia	En reclutamiento
New York Presbyterian - Brooklyn Methodist Hospital	Brooklyn	New York	En reclutamiento
Atrium Health Sanger Heart and Vascular Institute	Charlotte	North Carolina	En reclutamiento
University of Virginia	Charlottesville	Virginia	Finalizado antes de tiempo
University of Chicago	Chicago	Illinois	En reclutamiento
Advocate IMMC	Chicago	Illinois	En reclutamiento
The Ohio State University	Columbus	Ohio	En reclutamiento
John Muir Health	Concord	California	En reclutamiento
Henry Ford	Detroit	Michigan	En reclutamiento
Advocate Aurora - Good Samaritan	Downers Grove	Illinois	Finalizado antes de tiempo
Duke University Medical Center	Durham	North Carolina	Activo, sin reclutar
Ascenscion Alexian Brothers	Elk Grove Village	Illinois	En reclutamiento
Broward Health	Fort Lauderdale	Florida	En reclutamiento
Baylor Scott & White	Fort Worth	Texas	Retirado
Hackensack University Medical Center	Hackensack	New Jersey	En reclutamiento
Texas Heart Institute	Houston	Texas	En reclutamiento
University of Mississippi Medical Center	Jackson	Mississippi	En reclutamiento
Wellstar Research Institue	Marietta	Georgia	Finalizado antes de tiempo
Intermountain Health	Murray	Utah	Retirado
Jersey Shore University Medical Center	Neptune City	New Jersey	En reclutamiento
Nyph/Cumc	New York	New York	En reclutamiento
Northwell Health (Lenox Hill)	New York	New York	Finalizado antes de tiempo
Mount Sinai Morningside	New York	New York	En reclutamiento
Oklahoma Cardiovascular Research Group	Oklahoma City	Oklahoma	En reclutamiento
Ascension Sacred Heart	Pensacola	Florida	Retirado
Thomas Jefferson University Hospital	Philadelphia	Pennsylvania	Retirado
Penn Presbyterian Medical Center	Philadelphia	Pennsylvania	En reclutamiento
Mayo Clinic - Arizona	Phoenix	Arizona	En reclutamiento
Banner--University Medical Center Phoenix	Phoenix	Arizona	En reclutamiento
Baylor Scott & White	Plano	Texas	Retirado
Oregon Health & Sciences University	Portland	Oregon	Activo, sin reclutar
Nuvance Health	Poughkeepsie	New York	En reclutamiento
Virginia Commonwealth University	Richmond	Virginia	En reclutamiento
San Francisco Veterans Administration	San Francisco	California	Finalizado antes de tiempo
University of California San Francisco	San Francisco	California	En reclutamiento
Zuckerberg San Francisco General	San Francisco	California	En reclutamiento
HonorHealth Medical Center	Scottsdale	Arizona	Finalizado antes de tiempo
Northwell Health (Staten Island)	Staten Island	New York	En reclutamiento
Tallahassee Research Institute	Tallahassee	Florida	Finalizado antes de tiempo
AdventHealth Tampa	Tampa	Florida	En reclutamiento
BayCare Medical/St. Joseph's Hospital	Tampa	Florida	En reclutamiento
University of South Florida	Tampa	Florida	En reclutamiento
Cleveland Clinic Florida	Weston	Florida	En reclutamiento
Ascension via Christi Kansas	Wichita	Kansas	Finalizado antes de tiempo
Novant Health New Hanover Regional Medical Center	Wilmington	North Carolina	Retirado

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

25 de agosto de 2026
Centro añadido
1 site added (50 total)
4950
4 de agosto de 2026
Fecha de finalización aplazada
Primary completion delayed 365 days
2027-01-012028-01-01

Registro: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT05677100