Heart FailureAVOID-HFNCT01474200
Study of Heart Failure Hospitalizations After Aquapheresis Therapy Compared to Intravenous (IV) Diuretic Treatment
A study testing Isolated veno-venous ultrafiltration (AQ) and IV Loop Diuretics (LD) in people with Heart Failure and Cardiac Failure, run by Nuwellis, Inc. at 38 sites in United States.
Trial summary
The purpose of the research is to determine if patients have fewer Heart Failure (HF) events after receiving Aquapheresis (AQ) therapy compared to intravenous (IV) diuretics up to 90 days of discharge from the hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Cardiac Failure, Acute Decompensated Heart Failure (ADHF)
- What is being tested?
- Isolated veno-venous ultrafiltration (AQ) and IV Loop Diuretics (LD)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 38 sitesUnited States
- Study dates
- Jan 2012to Jul 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Male or non-pregnant female patients
- Admitted to the hospital with a primary diagnosis of acute decompensated heart failure (ADHF)
- On regularly scheduled oral loop diuretics prior to admission
- Fluid overload manifested by at least two of the following:
- Pitting edema (2+) of the lower extremities
Show all 13Show fewer
- Jugular venous distention > 8 cm
- Pulmonary edema or pleural effusion on chest x-ray
- Paroxysmal nocturnal dyspnea or ≥ two- pillow orthopnea
- Respiration rate ≥ 20 per minute.
- Have received ≤ 2 IV loop diuretics doses before randomization
- Must be able to be enrolled into the trial ≤ 24 hours of their admission to the hospital.
- Provide written informed consent form as required by the local IRB (Institutional Review Board)
Who cannot join
- Acute coronary syndromes
- Renal insufficiency with a sCr ≥ 3.0 mg/dl or planned renal replacement therapies
- Systolic blood pressure < 90 mmHg at time of enrollment
- Pulmonary Arterial Hypertension not secondary to left heart disease
- Contraindications to systemic anticoagulation
- Hematocrit > 45%
Show all 23Show fewer
- Inability to obtain venous access
- Hemodynamic instability severe enough to require IV positive inotropic agents, IV vasodilators or both
- Use of iodinated radiocontrast material within the previous 72 hours or planned study requiring IV contrast during the current hospitalization
- Severe concomitant disease expected to prolong hospitalization
- Severe concomitant disease expected to cause death in ≤ 90 days
- Sepsis or ongoing systemic infection
- Severe uncorrected valvular stenosis
- Active myocarditis
- Hypertrophic obstructive cardiomyopathy
- Constrictive pericarditis or restrictive cardiomyopathy
- Liver cirrhosis
- Previous solid organ transplant
- Requirement for mechanical ventilatory support
- Presence of a mechanical circulatory support device
- Unwillingness or inability to complete follow up
- Active drug or ETOH substance abuse
- Participating in another interventional clinical trial
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
United States38 sites
Abington Memorial Hospital
Abington, Pennsylvania, 19001
New Mexico Heart Institute/Heart Hospital
Albuquerque, New Mexico, 87102
Asheville Cardiology Associates
Asheville, North Carolina, 28803
Emory University
Atlanta, Georgia, 30322
St. Luke's Hospital and Health Network
Bethlehem, Pennsylvania, 18018
University of Cincinnati
Cincinnati, Ohio, 45219
Morton Plant Medical Center
Clearwater, Florida, 33756
MetroHealth Systems
Cleveland, Ohio, 44109
Cleveland Clinic
Cleveland, Ohio, 44195
The Ohio State University
Columbus, Ohio, 43210
Good Samaritan Hospital - Dayton
Dayton, Ohio, 45415
Iowa Health - Des Moines
Des Moines, Iowa, 50316
AtlantiCare Health Network
Egg Harbor, New Jersey, 08234
Elkhart General HealthCare
Elkhart, Indiana, 46514
Northwestern University
Evanston, Illinois, 60208
Northern Indiana Research Alliance
Fort Wayne, Indiana, 46804
Heart Center Research
Huntsville, Alabama, 35801
Saint Luke's Hospital and Saint Luke's Cardiovascular Consultants
Kansas City, Missouri, 64111
UCLA
Los Angeles, California, 90095
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Minneapolis VA Medical Center
Minneapolis, Minnesota, 55417
University of Minnesota
Minneapolis, Minnesota, 55455
Edward Hospital Center for Advanced Heart Failure
Naperville, Illinois, 60566
Saint Thomas Hospital
Nashville, Tennessee, 37205
Advocate Health & Hospitals Corporation
Oakbrook Terrace, Illinois, 60181
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23298
Brooke Army Medical Center
San Antonio, Texas, 78234
University of California, San Diego (UCSD)
San Diego, California, 92037
San Diego Cardiac Center
San Diego, California, 92123
Mayo Clinic - Scottsdale
Scottsdale, Arizona, 85054
Scottsdale Healthcare Research Institute
Scottsdale, Arizona, 85258
MultiCare Health System/Tacoma General Hospital
Tacoma, Washington, 98405
Oklahoma Heart Institute and Hillcrest Medical Center
Tulsa, Oklahoma, 74104
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Aquapheresis Versus Intravenous Diuretics and Hospitalizations for Heart Failure (AVOID-HF)
The purpose of the research is to determine if patients have fewer Heart Failure (HF) events after receiving Aquapheresis (AQ) therapy compared to intravenous (IV) diuretics up to 90 days of discharge from the hospital. Heart Failure events are defined as returning to the hospital, clinic or emergency department (ED) for treatment of HF symptoms.
Read the detailed description
The aim of the proposed AVOID-HF study is to confirm and expand the findings that fluid removal by AQ reduces HF rehospitalizations at 90 days as well as the length of these HF rehospitalizations. In the "Ultrafiltration Versus Intravenous Diuretics for Patients Hospitalized for Acute Decompensated Heart Failure" (UNLOAD) study, the 90 day HF re-hospitalizations were pre-specified secondary end-points. AVOID-HF is designed with a primary end-point to determine if AQ reduces the number of HF events (Rehospitalization or unscheduled outpatient or emergency room treatment for HF) after discharge from index hospitalization compared to IV loop diuretics. AVOID will also explore days alive and out of the hospital as a secondary end-point, which was not done in UNLOAD. In other words, the AVOID-HF study is going beyond studying only the amount of fluid removal and will explore whether the modality of fluid removal influences HF outcomes.
- Being tested
- Isolated veno-venous ultrafiltration (AQ), IV Loop Diuretics (LD)
- Keywords
- Ultrafiltration, Aquapheresis, Diuretics, Loop Diuretics, Aquadex Flexflow System, Gambro UF Solutions
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isolated veno-venous ultrafiltration (AQ)Device
Also called Aquapheresis, Ultrafiltration, Aquadex FlexFlow System, Gambro UF Solutions
Aquapheresis treatment (isolated veno-venous ultrafiltration) using the Aquadex FlexFlow System during index hospitalization until the patient's signs and symptoms of fluid overload have improved to the satisfaction of the treating physician. Ultrafiltration rates, duration and frequency of treatment are dependent on the amount of patient fluid excess and on the rate of fluid movement from the interstitial spaces into the vascular compartment during Aquapheresis (Plasma Refill Rate, or PRR)
IV Loop Diuretics (LD)Drug
Also called furosemide
IV Loop Diuretics treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload. This includes furosemide or other IV loop diuretics administered at equivalent doses to furosemide. Patients will receive either a twice daily IV bolus or continuous IV LD infusions according to the high dose protocol of the"Diuretic strategies in patients wth acute decompensated heart failure" (DOSE) trial.
| Study group | Role | What they receive |
|---|---|---|
| Aquapheresis (AQ) - isolated veno-venous ultrafiltration | Experimental | Excess fluid from the patient is removed by isolated veno-venous ultrafiltration treatment using the Aquadex Flex Flow System Receives: Device: Isolated veno-venous ultrafiltration (AQ) |
| IV Loop Diuretics (LD) | Active comparator | Excess fluid from the patient is removed by IV (Intravenous) loop diuretic treatment Receives: Drug: IV Loop Diuretics (LD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Heart Failure (HF) Event
Time to first HF event within 90 days after discharge from index HF hospitalization. HF events are defined as
- HF rehospitalization or
- unscheduled outpatient or emergency room treatment with IV loop diuretics or
- unscheduled outpatient Aquapheresis treatment
Measured: 90 days after discharge from index HF hospitalization.
Secondary outcomes (22)
EFFICACY: Total Fluid Removed During the Index Hospitalization
AQ-Fluid removed by AQ plus urine voided versus urine voided when treated with IV diuretics
Measured: Index Hospitalization, an average of 8 days
EFFICACY: Net Fluid Removed During the Index Hospitalization
AQ-Fluid removed by AQ plus urine voided minus fluid intake versus urine voided minus fluid intake with the IV diuretics.
Measured: Index Hospitalization, an average of 8 days
EFFICACY: Weight Loss at 72 Hours After Initiation of Treatment
Weight at 72 hours after treatment initiation minus weight at treatment initiation. Negative mean values indicate weight loss.
Measured: 72 hours after treatment initiation
EFFICACY: Total Weight Loss During the Index Hospitalization
Weight at hospital discharge minus weight at hospital admission. Negative mean values indicate weight loss.
Measured: Index Hospitalization, an average of 8 days
EFFICACY: Time to Freedom From Congestion
Time from hospital admission to time patient is free of congestion in the hospital. Freedom from congestion is defined as jugular venous distention of < or equal to 8 cm, with no orthopnea and with trace peripheral edema or no edema. Measurement taken every 24 hours after treatment initiation.
Measured: Index Hospitalization, an average of 8 days
EFFICACY: Freedom From Congestion
Defined as jugular venous distention of < or equal to 8 cm, with no orthopnea, and with trace peripheral edema or no edema at hospital discharge
Measured: Index Hospitalization, an average of 8 days
EFFICACY: Changes in B-type Natriuretic Peptide (BNP) Levels Over Time
Change in BNP levels over time at 72 hours, discharge, and 90 days after discharge.
Measured: Baseline and at 72 hours from baseline, hospital discharge and at 90 days after hospital discharge
Length of Stay (LOS) During the Index Hospitalization
Number of days patient is in hospital for HF treatment.
Measured: Index hospitalization admission to index hospitalization discharge
CLINICAL: Total Number of Days Rehospitalized for Heart Failure (HF) at 30 and 90 Days After Discharge
Days rehospitalized for HF symptoms requiring hospital, emergency room or clinic treatment involving the use of IV diuretics and /or positive inotropic or vasodilator drugs.
Measured: Within 30 days and 90 days after hospital discharge
CLINICAL: Total Number of Emergency Department (ED) or Unscheduled Office Visits at 30 and 90 Days After Discharge
Number of visits for HF symptoms requiring ED or clinic treatment involving the use of IV diuretics and /or positive inotropic or vasodilator drugs
Measured: Within 30 days and 90 days after hospital discharge
CLINICAL: Total Number of Heart Failure (HF) Rehospitalizations at 30 and 90 Days After Discharge
Number of different times patient was admitted to hospital for HF symptoms within 90 days of index hospitalization discharge.
Measured: Within 30 days and 90 days after hospital discharge
CLINICAL: Total Number of Cardiovascular (CV) Rehospitalizations at 30 and 90 Days After Discharge
CV symptoms that required hospitalization for treatment within 90 days of index hospitalization discharge.
Measured: Within 30 days and 90 days after hospital discharge
CLINICAL: Total Number of Days for Cardiovascular (CV) Rehospitalizations at 30 and 90 Days After Discharge
The total number of days spent in the hospital due to CV related events at 30 days and 90 days from hospital discharge.
Measured: Within 30 days and 90 days after hospital discharge
CLINICAL: All Cause Rehospitalization Rates at 30 and 90 Days
Any cause that required hospitalization for treatment within 90 days of index hospitalization discharge.
Measured: Within 30 days and 90 days after hospital discharge
Mortality Rates Within Index Hospitalization or Within 90 Days After Hospital Discharge.
Death due to any cause within index hospitalization and 90 days following hospital discharge.
Measured: Time from randomization to 90 days post-hospital discharge
Days Alive and Out of Hospital at 30 and 90 Days After Discharge
Number of days patients were alive and out of the hospital at 30 and 90 days after discharge.
Measured: Within 30 and 90 days after hospital discharge
Quality of Life Assessed Using the Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30, 60 and 90 Days After Discharge
Questionnaire assessed patients quality of life prior to index treatment versus timeframes following hospital discharge. Scores were transformed to a range of 0-100, in which higher scores reflect better health status.
Measured: Within 90 days after hospital discharge
CLINICAL: Global Clinical Score at 30 and 90 Days After Discharge
KCCQ Questionnaire analysis based on patient's self-assessment of how they feel at various intervals compared to how they felt prior to index treatment. Scores were transformed to a range of 0-100, in which higher scores reflect better health status.
Measured: Within 90 days after hospital discharge
SAFETY: Changes in Renal Function (Serum Creatinine) After Treatment up to 90 Days After Randomization
Changes in renal function prior to index treatment compared to various intervals by assessing the patient's serum creatinine (sCr), Blood Urea Nitrogen(BUN), BUN/sCr ratio and estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula
Measured: Within 90 days of randomization
SAFETY: Changes in Renal Function (Blood Urea Nitrogen) After Treatment up to 90 Days After Randomization
Changes in renal function prior to index treatment compared to various intervals by assessing the patient's serum creatinine (sCr), Blood Urea Nitrogen(BUN), BUN/sCr ratio and estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula
Measured: Within 90 days of randomization
SAFETY: Changes in Renal Function (Blood Urea Nitrogen/Serum Creatinine) After Treatment up to 90 Days After Randomization
Changes in renal function prior to index treatment compared to various intervals by assessing the patient's serum creatinine (sCr), Blood Urea Nitrogen(BUN), BUN/sCr ratio and estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula
Measured: Within 90 days of randomization
SAFETY: Changes in Renal Function (Estimated Glomerular Filtration Rate) After Treatment up to 90 Days After Randomization
Changes in renal function prior to index treatment compared to various intervals by assessing the patient's serum creatinine (sCr), Blood Urea Nitrogen(BUN), BUN/sCr ratio and estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula
Measured: Within 90 days of randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2011 (estimated)
- Study startJan 2012
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: Closed due to patient recruitment challenges. No interim analyses were completed; study closure was not related to any concerns about safety or futility.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nuwellis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maria Rosa Costanzo, MD, Principal investigator, Midwest Heart Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01474200
- Sponsor's protocol ID
- 1494
- Acronym
- AVOID-HF
- Status last verified
- Aug 2023
- First submitted
- 11 Nov 2011
- Last updated
- 29 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Costanzo MR, Guglin ME, Saltzberg MT, Jessup ML, Bart BA, Teerlink JR, Jaski BE, Fang JC, Feller ED, Haas GJ, Anderson AS, Schollmeyer MP, Sobotka PA; UNLOAD Trial Investigators. Ultrafiltration versus intravenous diuretics for patients hospitalized for acute decompensated heart failure. J Am Coll Cardiol. 2007 Feb 13;49(6):675-83. doi: 10.1016/j.jacc.2006.07.073. Epub 2007 Jan 26.
PubMed 17291932Adams KF Jr, Fonarow GC, Emerman CL, LeJemtel TH, Costanzo MR, Abraham WT, Berkowitz RL, Galvao M, Horton DP; ADHERE Scientific Advisory Committee and Investigators. Characteristics and outcomes of patients hospitalized for heart failure in the United States: rationale, design, and preliminary observations from the first 100,000 cases in the Acute Decompensated Heart Failure National Registry (ADHERE). Am Heart J. 2005 Feb;149(2):209-16. doi: 10.1016/j.ahj.2004.08.005.
PubMed 15846257Jain P, Massie BM, Gattis WA, Klein L, Gheorghiade M. Current medical treatment for the exacerbation of chronic heart failure resulting in hospitalization. Am Heart J. 2003 Feb;145(2 Suppl):S3-17. doi: 10.1067/mhj.2003.149. No abstract available.
PubMed 12594447Drazner MH, Rame JE, Stevenson LW, Dries DL. Prognostic importance of elevated jugular venous pressure and a third heart sound in patients with heart failure. N Engl J Med. 2001 Aug 23;345(8):574-81. doi: 10.1056/NEJMoa010641.
PubMed 11529211Domanski M, Norman J, Pitt B, Haigney M, Hanlon S, Peyster E; Studies of Left Ventricular Dysfunction. Diuretic use, progressive heart failure, and death in patients in the Studies Of Left Ventricular Dysfunction (SOLVD). J Am Coll Cardiol. 2003 Aug 20;42(4):705-8. doi: 10.1016/s0735-1097(03)00765-4.
PubMed 12932605Sharma A, Hermann DD, Mehta RL. Clinical benefit and approach of ultrafiltration in acute heart failure. Cardiology. 2001;96(3-4):144-54. doi: 10.1159/000047398.
PubMed 11805381Marenzi G, Lauri G, Grazi M, Assanelli E, Campodonico J, Agostoni P. Circulatory response to fluid overload removal by extracorporeal ultrafiltration in refractory congestive heart failure. J Am Coll Cardiol. 2001 Oct;38(4):963-8. doi: 10.1016/s0735-1097(01)01479-6.
PubMed 11583865Rimondini A, Cipolla CM, Della Bella P, Grazi S, Sisillo E, Susini G, Guazzi MD. Hemofiltration as short-term treatment for refractory congestive heart failure. Am J Med. 1987 Jul;83(1):43-8. doi: 10.1016/0002-9343(87)90495-5.
PubMed 3605181Jaski BE, Ha J, Denys BG, Lamba S, Trupp RJ, Abraham WT. Peripherally inserted veno-venous ultrafiltration for rapid treatment of volume overloaded patients. J Card Fail. 2003 Jun;9(3):227-31. doi: 10.1054/jcaf.2003.28.
PubMed 12815573Bart BA, Boyle A, Bank AJ, Anand I, Olivari MT, Kraemer M, Mackedanz S, Sobotka PA, Schollmeyer M, Goldsmith SR. Ultrafiltration versus usual care for hospitalized patients with heart failure: the Relief for Acutely Fluid-Overloaded Patients With Decompensated Congestive Heart Failure (RAPID-CHF) trial. J Am Coll Cardiol. 2005 Dec 6;46(11):2043-6. doi: 10.1016/j.jacc.2005.05.098. Epub 2005 Nov 4.
PubMed 16325039Costanzo MR, Saltzberg M, O'Sullivan J, Sobotka P. Early ultrafiltration in patients with decompensated heart failure and diuretic resistance. J Am Coll Cardiol. 2005 Dec 6;46(11):2047-51. doi: 10.1016/j.jacc.2005.05.099. Epub 2005 Nov 9.
PubMed 16325040Bart BA, Goldsmith SR, Lee KL, Givertz MM, O'Connor CM, Bull DA, Redfield MM, Deswal A, Rouleau JL, LeWinter MM, Ofili EO, Stevenson LW, Semigran MJ, Felker GM, Chen HH, Hernandez AF, Anstrom KJ, McNulty SE, Velazquez EJ, Ibarra JC, Mascette AM, Braunwald E; Heart Failure Clinical Research Network. Ultrafiltration in decompensated heart failure with cardiorenal syndrome. N Engl J Med. 2012 Dec 13;367(24):2296-304. doi: 10.1056/NEJMoa1210357. Epub 2012 Nov 6.
PubMed 23131078
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aquapheresis Versus Intravenous Diuretics and Hospitalizations for Heart Failure (AVOID-HF)
- ClinicalTrials.gov ID
- NCT01474200
- Acronym / sponsor ID
- AVOID-HF / 1494
- Keywords
- Ultrafiltration, Aquapheresis, Diuretics, Loop Diuretics, Aquadex Flexflow System, Gambro UF Solutions
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closed due to patient recruitment challenges. No interim analyses were completed; study closure was not related to any concerns about safety or futility.
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Nuwellis, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 18 Nov 2011 (estimated)
- Results
- Posted 12 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the research is to determine if patients have fewer Heart Failure (HF) events after receiving Aquapheresis (AQ) therapy compared to intravenous (IV) diuretics up to 90 days of discharge from the hospital. Heart Failure events are defined as returning to the hospital, clinic or emergency department (ED) for treatment of HF symptoms.
Detailed description
The aim of the proposed AVOID-HF study is to confirm and expand the findings that fluid removal by AQ reduces HF rehospitalizations at 90 days as well as the length of these HF rehospitalizations. In the "Ultrafiltration Versus Intravenous Diuretics for Patients Hospitalized for Acute Decompensated Heart Failure" (UNLOAD) study, the 90 day HF re-hospitalizations were pre-specified secondary end-points. AVOID-HF is designed with a primary end-point to determine if AQ reduces the number of HF events (Rehospitalization or unscheduled outpatient or emergency room treatment for HF) after discharge from index hospitalization compared to IV loop diuretics. AVOID will also explore days alive and out of the hospital as a secondary end-point, which was not done in UNLOAD. In other words, the AVOID-HF study is going beyond studying only the amount of fluid removal and will explore whether the modality of fluid removal influences HF outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aquapheresis (AQ) - isolated veno-venous ultrafiltration | Experimental | Device: Isolated veno-venous ultrafiltration (AQ)Excess fluid from the patient is removed by isolated veno-venous ultrafiltration treatment using the Aquadex Flex Flow System |
| IV Loop Diuretics (LD) | Active comparator | Drug: IV Loop Diuretics (LD)Excess fluid from the patient is removed by IV (Intravenous) loop diuretic treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 18 years of age or older
- Male or non-pregnant female patients
- Admitted to the hospital with a primary diagnosis of acute decompensated heart failure (ADHF)
- On regularly scheduled oral loop diuretics prior to admission
- Fluid overload manifested by at least two of the following:
Key exclusion criteria (23 listed)
- Acute coronary syndromes
- Renal insufficiency with a sCr ≥ 3.0 mg/dl or planned renal replacement therapies
- Systolic blood pressure < 90 mmHg at time of enrollment
- Pulmonary Arterial Hypertension not secondary to left heart disease
- Contraindications to systemic anticoagulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isolated veno-venous ultrafiltration (AQ)Also: Aquapheresis, Ultrafiltration, Aquadex FlexFlow System, Gambro UF SolutionsAquapheresis treatment (isolated veno-venous ultrafiltration) using the Aquadex FlexFlow System during index hospitalization until the patient's signs and symptoms of fluid overload have improved to the satisfaction of the treating physician. Ultrafiltration rates, duration and frequency of treatment are dependent on the amount of patient fluid excess and on the rate of fluid movement from the interstitial spaces into the vascular compartment during Aquapheresis (Plasma Refill Rate, or PRR) | Device | Aquapheresis (AQ) - isolated veno-venous ultrafiltration |
| IV Loop Diuretics (LD)Also: furosemideIV Loop Diuretics treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload. This includes furosemide or other IV loop diuretics administered at equivalent doses to furosemide. Patients will receive either a twice daily IV bolus or continuous IV LD infusions according to the high dose protocol of the"Diuretic strategies in patients wth acute decompensated heart failure" (DOSE) trial. | Drug | IV Loop Diuretics (LD) |
Primary outcome
Time to First Heart Failure (HF) Event
Time frame: 90 days after discharge from index HF hospitalization.
Time to first HF event within 90 days after discharge from index HF hospitalization. HF events are defined as * HF rehospitalization or * unscheduled outpatient or emergency room treatment with IV loop diuretics or * unscheduled outpatient Aquapheresis treatment
22 secondary outcomes
EFFICACY: Total Fluid Removed During the Index Hospitalization
Time frame: Index Hospitalization, an average of 8 days
EFFICACY: Net Fluid Removed During the Index Hospitalization
Time frame: Index Hospitalization, an average of 8 days
EFFICACY: Weight Loss at 72 Hours After Initiation of Treatment
Time frame: 72 hours after treatment initiation
EFFICACY: Total Weight Loss During the Index Hospitalization
Time frame: Index Hospitalization, an average of 8 days
EFFICACY: Time to Freedom From Congestion
Time frame: Index Hospitalization, an average of 8 days
EFFICACY: Freedom From Congestion
Time frame: Index Hospitalization, an average of 8 days
EFFICACY: Changes in B-type Natriuretic Peptide (BNP) Levels Over Time
Time frame: Baseline and at 72 hours from baseline, hospital discharge and at 90 days after hospital discharge
Length of Stay (LOS) During the Index Hospitalization
Time frame: Index hospitalization admission to index hospitalization discharge
CLINICAL: Total Number of Days Rehospitalized for Heart Failure (HF) at 30 and 90 Days After Discharge
Time frame: Within 30 days and 90 days after hospital discharge
CLINICAL: Total Number of Emergency Department (ED) or Unscheduled Office Visits at 30 and 90 Days After Discharge
Time frame: Within 30 days and 90 days after hospital discharge
CLINICAL: Total Number of Heart Failure (HF) Rehospitalizations at 30 and 90 Days After Discharge
Time frame: Within 30 days and 90 days after hospital discharge
CLINICAL: Total Number of Cardiovascular (CV) Rehospitalizations at 30 and 90 Days After Discharge
Time frame: Within 30 days and 90 days after hospital discharge
CLINICAL: Total Number of Days for Cardiovascular (CV) Rehospitalizations at 30 and 90 Days After Discharge
Time frame: Within 30 days and 90 days after hospital discharge
CLINICAL: All Cause Rehospitalization Rates at 30 and 90 Days
Time frame: Within 30 days and 90 days after hospital discharge
Mortality Rates Within Index Hospitalization or Within 90 Days After Hospital Discharge.
Time frame: Time from randomization to 90 days post-hospital discharge
Days Alive and Out of Hospital at 30 and 90 Days After Discharge
Time frame: Within 30 and 90 days after hospital discharge
Quality of Life Assessed Using the Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30, 60 and 90 Days After Discharge
Time frame: Within 90 days after hospital discharge
CLINICAL: Global Clinical Score at 30 and 90 Days After Discharge
Time frame: Within 90 days after hospital discharge
SAFETY: Changes in Renal Function (Serum Creatinine) After Treatment up to 90 Days After Randomization
Time frame: Within 90 days of randomization
SAFETY: Changes in Renal Function (Blood Urea Nitrogen) After Treatment up to 90 Days After Randomization
Time frame: Within 90 days of randomization
SAFETY: Changes in Renal Function (Blood Urea Nitrogen/Serum Creatinine) After Treatment up to 90 Days After Randomization
Time frame: Within 90 days of randomization
SAFETY: Changes in Renal Function (Estimated Glomerular Filtration Rate) After Treatment up to 90 Days After Randomization
Time frame: Within 90 days of randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17291932Costanzo MR, Guglin ME, Saltzberg MT, Jessup ML, Bart BA, Teerlink JR, Jaski BE, Fang JC, Feller ED, Haas GJ, Anderson AS, Schollmeyer MP, Sobotka PA; UNLOAD Trial Investigators. Ultrafiltration versus intravenous diuretics for patients hospitalized for acute decompensated heart failure. J Am Coll Cardiol. 2007 Feb 13;49(6):675-83. doi: 10.1016/j.jacc.2006.07.073. Epub 2007 Jan 26.
- Background: PubMed 15846257Adams KF Jr, Fonarow GC, Emerman CL, LeJemtel TH, Costanzo MR, Abraham WT, Berkowitz RL, Galvao M, Horton DP; ADHERE Scientific Advisory Committee and Investigators. Characteristics and outcomes of patients hospitalized for heart failure in the United States: rationale, design, and preliminary observations from the first 100,000 cases in the Acute Decompensated Heart Failure National Registry (ADHERE). Am Heart J. 2005 Feb;149(2):209-16. doi: 10.1016/j.ahj.2004.08.005.
- Background: PubMed 12594447Jain P, Massie BM, Gattis WA, Klein L, Gheorghiade M. Current medical treatment for the exacerbation of chronic heart failure resulting in hospitalization. Am Heart J. 2003 Feb;145(2 Suppl):S3-17. doi: 10.1067/mhj.2003.149. No abstract available.
- Background: PubMed 11529211Drazner MH, Rame JE, Stevenson LW, Dries DL. Prognostic importance of elevated jugular venous pressure and a third heart sound in patients with heart failure. N Engl J Med. 2001 Aug 23;345(8):574-81. doi: 10.1056/NEJMoa010641.
- Background: PubMed 12932605Domanski M, Norman J, Pitt B, Haigney M, Hanlon S, Peyster E; Studies of Left Ventricular Dysfunction. Diuretic use, progressive heart failure, and death in patients in the Studies Of Left Ventricular Dysfunction (SOLVD). J Am Coll Cardiol. 2003 Aug 20;42(4):705-8. doi: 10.1016/s0735-1097(03)00765-4.
- Background: PubMed 11805381Sharma A, Hermann DD, Mehta RL. Clinical benefit and approach of ultrafiltration in acute heart failure. Cardiology. 2001;96(3-4):144-54. doi: 10.1159/000047398.
- Background: PubMed 11583865Marenzi G, Lauri G, Grazi M, Assanelli E, Campodonico J, Agostoni P. Circulatory response to fluid overload removal by extracorporeal ultrafiltration in refractory congestive heart failure. J Am Coll Cardiol. 2001 Oct;38(4):963-8. doi: 10.1016/s0735-1097(01)01479-6.
- Background: PubMed 3605181Rimondini A, Cipolla CM, Della Bella P, Grazi S, Sisillo E, Susini G, Guazzi MD. Hemofiltration as short-term treatment for refractory congestive heart failure. Am J Med. 1987 Jul;83(1):43-8. doi: 10.1016/0002-9343(87)90495-5.
- Background: PubMed 12815573Jaski BE, Ha J, Denys BG, Lamba S, Trupp RJ, Abraham WT. Peripherally inserted veno-venous ultrafiltration for rapid treatment of volume overloaded patients. J Card Fail. 2003 Jun;9(3):227-31. doi: 10.1054/jcaf.2003.28.
- Background: PubMed 16325039Bart BA, Boyle A, Bank AJ, Anand I, Olivari MT, Kraemer M, Mackedanz S, Sobotka PA, Schollmeyer M, Goldsmith SR. Ultrafiltration versus usual care for hospitalized patients with heart failure: the Relief for Acutely Fluid-Overloaded Patients With Decompensated Congestive Heart Failure (RAPID-CHF) trial. J Am Coll Cardiol. 2005 Dec 6;46(11):2043-6. doi: 10.1016/j.jacc.2005.05.098. Epub 2005 Nov 4.
- Background: PubMed 16325040Costanzo MR, Saltzberg M, O'Sullivan J, Sobotka P. Early ultrafiltration in patients with decompensated heart failure and diuretic resistance. J Am Coll Cardiol. 2005 Dec 6;46(11):2047-51. doi: 10.1016/j.jacc.2005.05.099. Epub 2005 Nov 9.
- Background: PubMed 23131078Bart BA, Goldsmith SR, Lee KL, Givertz MM, O'Connor CM, Bull DA, Redfield MM, Deswal A, Rouleau JL, LeWinter MM, Ofili EO, Stevenson LW, Semigran MJ, Felker GM, Chen HH, Hernandez AF, Anstrom KJ, McNulty SE, Velazquez EJ, Ibarra JC, Mascette AM, Braunwald E; Heart Failure Clinical Research Network. Ultrafiltration in decompensated heart failure with cardiorenal syndrome. N Engl J Med. 2012 Dec 13;367(24):2296-304. doi: 10.1056/NEJMoa1210357. Epub 2012 Nov 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Rosa Costanzo, MD principal investigator
Midwest Heart Foundation
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isolated veno-venous ultrafiltration (AQ) and IV Loop Diuretics (LD) in people with Heart Failure and Cardiac Failure, run by Nuwellis, Inc. at 38 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to First Heart Failure (HF) Event (time frame: 90 days after discharge from index HF hospitalization.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01474200, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2023.