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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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…

Interventionell320 Teilnehmende gesucht50 Studienzentren2 Länder

Kategorien

Herz-Kreislauf84%Nephrologie und Urologie13%Geburtshilfe und Gynäkologie3%

In 1 Register registriert

ClinicalTrials.govNCT05677100Diesen Eintrag bei ClinicalTrials.gov öffnenSynchronisiert vor 4 Wochen

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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.

Zusammenfassung

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.

Erkrankungen

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

Eignung

Eignung
Geschlecht	Alle
Alter	21 Years – Kein Höchstalter
Gesunde Freiwillige	Nein

Eignung im Wortlaut des Registers

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.

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

Studiendesign
Studientyp	Interventionell
Phase	Nicht zutreffend
Zuteilung	Randomisiert
Interventionsmodell	PARALLEL
Primäres Ziel	TREATMENT
Verblindung	NONE (0)
Teilnahme	320 Teilnehmende gesucht

Sponsor und Mitwirkende

Procyrion Sponsor

Studienarme und Interventionen

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.

Interventionen

Medizinprodukt 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.

Endpunkte

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

Daten

Daten
Startdatum	23. August 2023 (tatsächlich)
Primärer Abschluss	1. Januar 2028 (geschätzt)
Abschluss	1. August 2028 (geschätzt)
Erstveröffentlichung	10. Januar 2023 (tatsächlich)
Zuletzt aktualisiert	25. August 2026
Ergebnisse veröffentlicht	Im Registereintrag nicht angegeben
Status zuletzt bestätigt	August 2026

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

33 Studienzentren rekrutieren

Hungary

Hungary
Einrichtung	Stadt	Bundesland oder Region	Status
Semmelweis University	Budapest		Rekrutiert

United States

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

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

25. August 2026
Studienzentrum hinzugefügt
1 site added (50 total)
4950
4. August 2026
Abschlussdatum nach hinten verschoben
Primary completion delayed 365 days
2027-01-012028-01-01

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