Aquapheresis Versus Intravenous Diuretics and Hospitalizations for Heart Failure (AVOID-HF)
| Registry | NCT01474200, acronym AVOID-HF |
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| Status | Terminated - Closed due to patient recruitment challenges. No interim analyses were completed; study closure was not related to any concerns about safety or futility. |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, parallel, masking: none, treatment |
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| Enrollment | 224 (Actual) |
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| Sponsor | Nuwellis, Inc. (Industry) |
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| Conditions | Heart Failure, Cardiac Failure, Acute Decompensated Heart Failure (ADHF) |
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| Interventions | Isolated veno-venous ultrafiltration (AQ), IV Loop Diuretics (LD) (Device, drug) |
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| Dates | start 2012-01-01, primary completion 2014-07-01, completion 2014-07-01, first posted 2011-11-18, last updated 2023-08-29 |
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| Locations | 38 sites in United States |
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Related Papers Related Patents Related Grants Related Experts
All trials for Heart Failure All trials for Cardiac Failure All trials of Isolated veno-venous ultrafiltration (AQ) All trials of IV Loop Diuretics (LD)
-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. Heart Failure events are defined as returning to the hospital, clinic or emergency department (ED) for treatment of HF symptoms.
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+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.
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| 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 |
- Isolated veno-venous ultrafiltration (AQ) (Device), also known as 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 known as 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.
+Outcome measures
Primary outcomes
- Time to First Heart Failure (HF) Event [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
Secondary outcomes
- EFFICACY: Total Fluid Removed During the Index Hospitalization [Index Hospitalization, an average of 8 days]: AQ-Fluid removed by AQ plus urine voided versus urine voided when treated with IV diuretics
- EFFICACY: Net Fluid Removed During the Index Hospitalization [Index Hospitalization, an average of 8 days]: AQ-Fluid removed by AQ plus urine voided minus fluid intake versus urine voided minus fluid intake with the IV diuretics.
- EFFICACY: Weight Loss at 72 Hours After Initiation of Treatment [72 hours after treatment initiation]: Weight at 72 hours after treatment initiation minus weight at treatment initiation. Negative mean values indicate weight loss.
- EFFICACY: Total Weight Loss During the Index Hospitalization [Index Hospitalization, an average of 8 days]: Weight at hospital discharge minus weight at hospital admission. Negative mean values indicate weight loss.
- EFFICACY: Time to Freedom From Congestion [Index Hospitalization, an average of 8 days]: 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.
- EFFICACY: Freedom From Congestion [Index Hospitalization, an average of 8 days]: 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
- EFFICACY: Changes in B-type Natriuretic Peptide (BNP) Levels Over Time [Baseline and at 72 hours from baseline, hospital discharge and at 90 days after hospital discharge]: Change in BNP levels over time at 72 hours, discharge, and 90 days after discharge.
- Length of Stay (LOS) During the Index Hospitalization [Index hospitalization admission to index hospitalization discharge]: Number of days patient is in hospital for HF treatment.
- CLINICAL: Total Number of Days Rehospitalized for Heart Failure (HF) at 30 and 90 Days After Discharge [Within 30 days and 90 days after hospital 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.
- CLINICAL: Total Number of Emergency Department (ED) or Unscheduled Office Visits at 30 and 90 Days After Discharge [Within 30 days and 90 days after hospital 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
- CLINICAL: Total Number of Heart Failure (HF) Rehospitalizations at 30 and 90 Days After Discharge [Within 30 days and 90 days after hospital discharge]: Number of different times patient was admitted to hospital for HF symptoms within 90 days of index hospitalization discharge.
- CLINICAL: Total Number of Cardiovascular (CV) Rehospitalizations at 30 and 90 Days After Discharge [Within 30 days and 90 days after hospital discharge]: CV symptoms that required hospitalization for treatment within 90 days of index hospitalization discharge.
- CLINICAL: Total Number of Days for Cardiovascular (CV) Rehospitalizations at 30 and 90 Days After Discharge [Within 30 days and 90 days after hospital discharge]: The total number of days spent in the hospital due to CV related events at 30 days and 90 days from hospital discharge.
- CLINICAL: All Cause Rehospitalization Rates at 30 and 90 Days [Within 30 days and 90 days after hospital discharge]: Any cause that required hospitalization for treatment within 90 days of index hospitalization discharge.
- Mortality Rates Within Index Hospitalization or Within 90 Days After Hospital Discharge. [Time from randomization to 90 days post-hospital discharge]: Death due to any cause within index hospitalization and 90 days following hospital discharge.
- Days Alive and Out of Hospital at 30 and 90 Days After Discharge [Within 30 and 90 days after hospital discharge]: Number of days patients were alive and out of the hospital at 30 and 90 days after discharge.
- Quality of Life Assessed Using the Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30, 60 and 90 Days After Discharge [Within 90 days after hospital 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.
- CLINICAL: Global Clinical Score at 30 and 90 Days After Discharge [Within 90 days after hospital 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.
- SAFETY: Changes in Renal Function (Serum Creatinine) After Treatment up to 90 Days After Randomization [Within 90 days of 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
- SAFETY: Changes in Renal Function (Blood Urea Nitrogen) After Treatment up to 90 Days After Randomization [Within 90 days of 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
- SAFETY: Changes in Renal Function (Blood Urea Nitrogen/Serum Creatinine) After Treatment up to 90 Days After Randomization [Within 90 days of 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
- SAFETY: Changes in Renal Function (Estimated Glomerular Filtration Rate) After Treatment up to 90 Days After Randomization [Within 90 days of 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
+Eligibility
Sex: All, ages: 18 Years to any
Inclusion Criteria:
1. 18 years of age or older
2. Male or non-pregnant female patients
3. Admitted to the hospital with a primary diagnosis of acute decompensated heart failure (ADHF)
4. On regularly scheduled oral loop diuretics prior to admission
5. Fluid overload manifested by at least two of the following:
1. Pitting edema (2+) of the lower extremities
2. Jugular venous distention > 8 cm
3. Pulmonary edema or pleural effusion on chest x-ray
4. Paroxysmal nocturnal dyspnea or ≥ two- pillow orthopnea
5. Respiration rate ≥ 20 per minute.
6. Have received ≤ 2 IV loop diuretics doses before randomization
7. Must be able to be enrolled into the trial ≤ 24 hours of their admission to the hospital.
8. Provide written informed consent form as required by the local IRB (Institutional Review Board)
Exclusion Criteria:
1. Acute coronary syndromes
2. Renal insufficiency with a sCr ≥ 3.0 mg/dl or planned renal replacement therapies
3. Systolic blood pressure < 90 mmHg at time of enrollment
4. Pulmonary Arterial Hypertension not secondary to left heart disease
5. Contraindications to systemic anticoagulation
6. Hematocrit > 45%
7. Inability to obtain venous access
8. Hemodynamic instability severe enough to require IV positive inotropic agents, IV vasodilators or both
9. Use of iodinated radiocontrast material within the previous 72 hours or planned study requiring IV contrast during the current hospitalization
10. Severe concomitant disease expected to prolong hospitalization
11. Severe concomitant disease expected to cause death in ≤ 90 days
12. Sepsis or ongoing systemic infection
13. Severe uncorrected valvular stenosis
14. Active myocarditis
15. Hypertrophic obstructive cardiomyopathy
16. Constrictive pericarditis or restrictive cardiomyopathy
17. Liver cirrhosis
18. Previous solid organ transplant
19. Requirement for mechanical ventilatory support
20. Presence of a mechanical circulatory support device
21. Unwillingness or inability to complete follow up
22. Active drug or ETOH substance abuse
23. Participating in another interventional clinical trial
+Posted results
Participant flow
| Milestone | Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration | IV Loop Diuretics (LD) |
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| Started | 110 | 114 |
| Completed | 81 | 84 |
| Not completed | 29 | 30 |
Outcome results
- Time to First Heart Failure (HF) Event (Primary), Median, Days: Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration 62 (42 to NA); IV Loop Diuretics (LD) 34 (20 to 62)
- EFFICACY: Total Fluid Removed During the Index Hospitalization (Secondary), Mean, mL: Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration 18700 +/- 23033; IV Loop Diuretics (LD) 14043 +/- 15299
- EFFICACY: Net Fluid Removed During the Index Hospitalization (Secondary), Mean, mL: Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration 12921 +/- 20564; IV Loop Diuretics (LD) 8907 +/- 13329
- EFFICACY: Weight Loss at 72 Hours After Initiation of Treatment (Secondary), Mean, lbs: Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration -10.69 +/- 7.20; IV Loop Diuretics (LD) -10.30 +/- 9.22
- EFFICACY: Total Weight Loss During the Index Hospitalization (Secondary), Mean, lbs: Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration -17.12 +/- 12.59; IV Loop Diuretics (LD) -16.21 +/- 14.23
- EFFICACY: Time to Freedom From Congestion (Secondary), Mean, Days: Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration 5.28 +/- 4.11; IV Loop Diuretics (LD) 3.86 +/- 3.23
- EFFICACY: Freedom From Congestion (Secondary), Number, Participants: Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration 40; IV Loop Diuretics (LD) 46
- EFFICACY: Changes in B-type Natriuretic Peptide (BNP) Levels Over Time (Secondary), Mean, pg/mL: Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration 814.0 +/- 827.66; IV Loop Diuretics (LD) 904.1 +/- 843.44
- Length of Stay (LOS) During the Index Hospitalization (Secondary), Mean, Days: Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration 8.49 +/- 5.73; IV Loop Diuretics (LD) 7.19 +/- 5.37
- CLINICAL: Total Number of Days Rehospitalized for Heart Failure (HF) at 30 and 90 Days After Discharge (Secondary), Number, Days: Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration 68; IV Loop Diuretics (LD) 172
- CLINICAL: Total Number of Emergency Department (ED) or Unscheduled Office Visits at 30 and 90 Days After Discharge (Secondary), Number, Visits: Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration 4; IV Loop Diuretics (LD) 5
- CLINICAL: Total Number of Heart Failure (HF) Rehospitalizations at 30 and 90 Days After Discharge (Secondary), Number, Rehospitalizations: Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration 11; IV Loop Diuretics (LD) 24
- CLINICAL: Total Number of Cardiovascular (CV) Rehospitalizations at 30 and 90 Days After Discharge (Secondary), Number, Rehospitalizations: Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration 17; IV Loop Diuretics (LD) 33
- CLINICAL: Total Number of Days for Cardiovascular (CV) Rehospitalizations at 30 and 90 Days After Discharge (Secondary), Number, Days: Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration 88; IV Loop Diuretics (LD) 207
- CLINICAL: All Cause Rehospitalization Rates at 30 and 90 Days (Secondary), Number, Rehospitalizations/100 Pt-Days at Risk: Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration 0.899; IV Loop Diuretics (LD) 1.278
- Mortality Rates Within Index Hospitalization or Within 90 Days After Hospital Discharge. (Secondary), Number, Percentage of Participants: Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration 15.45; IV Loop Diuretics (LD) 12.61
- Days Alive and Out of Hospital at 30 and 90 Days After Discharge (Secondary), Mean, Days: Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration 27.29 +/- 5.78; IV Loop Diuretics (LD) 26.46 +/- 6.34
- Quality of Life Assessed Using the Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30, 60 and 90 Days After Discharge (Secondary), Mean, Scores on a Scale: Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration 25.39 +/- 19.37; IV Loop Diuretics (LD) 28.64 +/- 22.59
- CLINICAL: Global Clinical Score at 30 and 90 Days After Discharge (Secondary), Mean, Scores on a Scale: Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration 28.26 +/- 18.65; IV Loop Diuretics (LD) 31.83 +/- 18.63
- SAFETY: Changes in Renal Function (Serum Creatinine) After Treatment up to 90 Days After Randomization (Secondary), Mean, mg/dL: Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration 0.12 +/- 0.42; IV Loop Diuretics (LD) 0.12 +/- 0.50
- 3 more outcome measures not shown.
Adverse events
Time frame: Baseline through 90 days after discharge.
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|
| Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration | 0 | 73/110 (66.4%) | 25/110 (22.7%) |
| IV Loop Diuretics (LD) | 0 | 67/111 (60.4%) | 18/111 (16.2%) |
Serious adverse events by term
| Term | Organ system | Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration | IV Loop Diuretics (LD) |
|---|
| Cardiac Failure | Cardiac disorders | 5/110 | 8/111 |
| Cardiac Failure Acute | Cardiac disorders | 13/110 | 19/111 |
| Cardiac Failure Congestive | Cardiac disorders | 11/110 | 20/111 |
| Chest Pain | General disorders | 4/110 | 1/111 |
| Pneumonia | Infections and infestations | 5/110 | 0/111 |
| Blood Creatinine Increase | Investigations | 4/110 | 0/111 |
| Renal Failure Acute | Renal and urinary disorders | 4/110 | 3/111 |
| Hypotension | Vascular disorders | 3/110 | 5/111 |
| Acute Coronary Syndrom | Cardiac disorders | 1/110 | 0/111 |
| Acute Myocardial Infarction | Cardiac disorders | 1/110 | 0/111 |
| Arrhythmia | Cardiac disorders | 1/110 | 0/111 |
| Atrial Fibrillation | Cardiac disorders | 3/110 | 2/111 |
| Atrioventricular Block Second Degree | Cardiac disorders | 1/110 | 0/111 |
| Cardiac Arrest | Cardiac disorders | 3/110 | 2/111 |
| Cardiac Failure Chronic | Cardiac disorders | 2/110 | 3/111 |
| Cardio-Respiratory Arrest | Cardiac disorders | 2/110 | 1/111 |
| Cardiogenic Shock | Cardiac disorders | 1/110 | 0/111 |
| Cardiomyopathy | Cardiac disorders | 1/110 | 1/111 |
| Cardiorenal Syndrome | Cardiac disorders | 0/110 | 1/111 |
| Cardiovascular Insufficiency | Cardiac disorders | 1/110 | 0/111 |
| Congestive Cardiomyopathy | Cardiac disorders | 1/110 | 0/111 |
| Cor Pulmonale | Cardiac disorders | 0/110 | 2/111 |
| Ischaemic Cardiomyopathy | Cardiac disorders | 0/110 | 1/111 |
| Myocardial Infarction | Cardiac disorders | 1/110 | 0/111 |
| Palpitations | Cardiac disorders | 1/110 | 0/111 |
| Right Ventricular Failure | Cardiac disorders | 0/110 | 1/111 |
| Supra Ventricular Tachycardia | Cardiac disorders | 0/110 | 1/111 |
| Ventricular Tachycardia | Cardiac disorders | 2/110 | 0/111 |
| Abdominal Pain Lower | Gastrointestinal disorders | 0/110 | 1/111 |
| Abdominal Pain Upper | Gastrointestinal disorders | 0/110 | 1/111 |
| Abdominal Wall Haematoma | Gastrointestinal disorders | 1/110 | 0/111 |
| Gastric Antral Vascular Ectasia | Gastrointestinal disorders | 1/110 | 0/111 |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | 2/110 | 1/111 |
| Lower Gastrointestinal Haemorrhage | Gastrointestinal disorders | 1/110 | 0/111 |
| Pancreatitis | Gastrointestinal disorders | 1/110 | 0/111 |
| Upper Gastrointestinal Haemorrhage | Gastrointestinal disorders | 0/110 | 1/111 |
| Cardiac Death | General disorders | 0/110 | 1/111 |
| Chest Discomfort | General disorders | 1/110 | 0/111 |
| Death | General disorders | 0/110 | 3/111 |
| Device Lead Issue | General disorders | 0/110 | 1/111 |
| Malaise | General disorders | 1/110 | 0/111 |
| Medical Device Complication | General disorders | 0/110 | 1/111 |
| Non-Cardiac Chest Pain | General disorders | 1/110 | 1/111 |
| Pain | General disorders | 0/110 | 1/111 |
| Pyrexia | General disorders | 1/110 | 0/111 |
| Gallbladder Perforation | Hepatobiliary disorders | 0/110 | 1/111 |
| Sarcoidosis | Immune system disorders | 1/110 | 0/111 |
| Cellulitis | Infections and infestations | 2/110 | 2/111 |
| Filariasis | Infections and infestations | 1/110 | 0/111 |
| Infection | Infections and infestations | 2/110 | 0/111 |
| Sepsis | Infections and infestations | 1/110 | 1/111 |
| Septic Shock | Infections and infestations | 0/110 | 1/111 |
| Staphylococcal Infection | Infections and infestations | 1/110 | 0/111 |
| Upper Respiratory Tract Infection | Infections and infestations | 2/110 | 0/111 |
| Urinary Tract Infection | Infections and infestations | 0/110 | 1/111 |
| Wound Infection | Infections and infestations | 1/110 | 0/111 |
| Hip Fracture | Injury, poisoning and procedural complications | 1/110 | 0/111 |
| Procedural Haemorrhage | Injury, poisoning and procedural complications | 1/110 | 0/111 |
| Renal Haematoma | Injury, poisoning and procedural complications | 1/110 | 0/111 |
| Spinal Compression Fracture | Injury, poisoning and procedural complications | 1/110 | 0/111 |
41 more terms not shown.
Other adverse events by term
| Term | Organ system | Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration | IV Loop Diuretics (LD) |
|---|
| Blood Creatinine Increase | Investigations | 7/110 | 4/111 |
| Hypotension | Vascular disorders | 12/110 | 7/111 |
| Urinary Tract Infection | Infections and infestations | 3/110 | 7/111 |
| Hyperkalaemia | Metabolism and nutrition disorders | 8/110 | 4/111 |
| Renal Failure Acute | Renal and urinary disorders | 5/110 | 7/111 |
Limitations and caveats: Due to patient recruitment challenges, the study was terminated early. At that time, no interim analyses of the data had been completed; therefore the decision to close the study was not related to any underlying concerns about safety or futility.
+Locations (38)
| Facility | City | Country | Status |
|---|
| Heart Center Research | Huntsville, Alabama | United States | |
| Mayo Clinic - Scottsdale | Scottsdale, Arizona | United States | |
| Scottsdale Healthcare Research Institute | Scottsdale, Arizona | United States | |
| UCLA | Los Angeles, California | United States | |
| University of California, San Diego (UCSD) | San Diego, California | United States | |
| San Diego Cardiac Center | San Diego, California | United States | |
| Washington Hospital Center | Washington D.C., District of Columbia | United States | |
| Morton Plant Medical Center | Clearwater, Florida | United States | |
| Emory University | Atlanta, Georgia | United States | |
| Northwestern University | Evanston, Illinois | United States | |
| Edward Hospital Center for Advanced Heart Failure | Naperville, Illinois | United States | |
| Advocate Health & Hospitals Corporation | Oakbrook Terrace, Illinois | United States | |
| Elkhart General HealthCare | Elkhart, Indiana | United States | |
| Northern Indiana Research Alliance | Fort Wayne, Indiana | United States | |
| Iowa Health - Des Moines | Des Moines, Iowa | United States | |
| Hennepin County Medical Center | Minneapolis, Minnesota | United States | |
| Minneapolis VA Medical Center | Minneapolis, Minnesota | United States | |
| University of Minnesota | Minneapolis, Minnesota | United States | |
| Saint Luke's Hospital and Saint Luke's Cardiovascular Consultants | Kansas City, Missouri | United States | |
| AtlantiCare Health Network | Egg Harbor, New Jersey | United States | |
| New Mexico Heart Institute/Heart Hospital | Albuquerque, New Mexico | United States | |
| Asheville Cardiology Associates | Asheville, North Carolina | United States | |
| University of Cincinnati | Cincinnati, Ohio | United States | |
| MetroHealth Systems | Cleveland, Ohio | United States | |
| Cleveland Clinic | Cleveland, Ohio | United States | |
| The Ohio State University | Columbus, Ohio | United States | |
| Good Samaritan Hospital - Dayton | Dayton, Ohio | United States | |
| Oklahoma Heart Institute and Hillcrest Medical Center | Tulsa, Oklahoma | United States | |
| Abington Memorial Hospital | Abington, Pennsylvania | United States | |
| St. Luke's Hospital and Health Network | Bethlehem, Pennsylvania | United States | |
| Drexel University College of Medicine | Philadelphia, Pennsylvania | United States | |
| University of Pennsylvania | Philadelphia, Pennsylvania | United States | |
| Albert Einstein Medical Center | Philadelphia, Pennsylvania | United States | |
| Saint Thomas Hospital | Nashville, Tennessee | United States | |
| Brooke Army Medical Center | San Antonio, Texas | United States | |
| Virginia Commonwealth University Medical Center | Richmond, Virginia | United States | |
| MultiCare Health System/Tacoma General Hospital | Tacoma, Washington | United States | |
| Aurora St. Luke's Medical Center | Milwaukee, Wisconsin | United States | |
+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. PMID 17291932
- Adams 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. PMID 15846257
- Jain 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. PMID 12594447
- Drazner 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. PMID 11529211
- Domanski 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. PMID 12932605
- Sharma 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. PMID 11805381
- Marenzi 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. PMID 11583865
- Rimondini 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. PMID 3605181
- Jaski 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. PMID 12815573
- Bart 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. PMID 16325039
- Costanzo 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. PMID 16325040
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