Back to resultsStudy of Heart Failure Hospitalizations After Aquapheresis Therapy Compared to Intravenous (IV) Diuretic Treatment (AVOID-HF)
Primary Purpose
Heart Failure, Cardiac Failure, Acute Decompensated Heart Failure (ADHF)
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Isolated veno-venous ultrafiltration (AQ)
IV Loop Diuretics (LD)
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Ultrafiltration, Aquapheresis, Diuretics, Loop Diuretics, Aquadex Flexflow System, Gambro UF Solutions
Eligibility Criteria
Inclusion Criteria:
- 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
- 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)
Exclusion Criteria:
- 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%
- 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
Sites / Locations
- Heart Center Research
- Mayo Clinic - Scottsdale
- Scottsdale Healthcare Research Institute
- UCLA
- University of California, San Diego (UCSD)
- San Diego Cardiac Center
- Washington Hospital Center
- Morton Plant Medical Center
- Emory University
- Northwestern University
- Edward Hospital Center for Advanced Heart Failure
- Advocate Health & Hospitals Corporation
- Elkhart General HealthCare
- Northern Indiana Research Alliance
- Iowa Health - Des Moines
- Hennepin County Medical Center
- Minneapolis VA Medical Center
- University of Minnesota
- Saint Luke's Hospital and Saint Luke's Cardiovascular Consultants
- AtlantiCare Health Network
- New Mexico Heart Institute/Heart Hospital
- Asheville Cardiology Associates
- University of Cincinnati
- MetroHealth Systems
- Cleveland Clinic
- The Ohio State University
- Good Samaritan Hospital - Dayton
- Oklahoma Heart Institute and Hillcrest Medical Center
- Abington Memorial Hospital
- St. Luke's Hospital and Health Network
- Drexel University College of Medicine
- University of Pennsylvania
- Albert Einstein Medical Center
- Saint Thomas Hospital
- Brooke Army Medical Center
- Virginia Commonwealth University Medical Center
- MultiCare Health System/Tacoma General Hospital
- Aurora St. Luke's Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Aquapheresis (AQ) - isolated veno-venous ultrafiltration
IV Loop Diuretics (LD)
Arm Description
Excess fluid from the patient is removed by isolated veno-venous ultrafiltration treatment using the Aquadex Flex Flow System
Excess fluid from the patient is removed by IV (Intravenous) loop diuretic treatment
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
EFFICACY: Total Fluid Removed During the Index Hospitalization
AQ-Fluid removed by AQ plus urine voided versus urine voided when treated with IV diuretics
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.
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.
EFFICACY: Total Weight Loss During the Index Hospitalization
Weight at hospital discharge minus weight at hospital admission. Negative mean values indicate weight loss.
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.
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
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.
Length of Stay (LOS) During the Index Hospitalization
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
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
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
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
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
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
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.
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
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
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
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
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
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01474200
Brief Title
Study of Heart Failure Hospitalizations After Aquapheresis Therapy Compared to Intravenous (IV) Diuretic Treatment
Acronym
AVOID-HF
Official Title
Aquapheresis Versus Intravenous Diuretics and Hospitalizations for Heart Failure (AVOID-HF)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
Closed due to patient recruitment challenges. No interim analyses were completed; study closure was not related to any concerns about safety or futility.
Study Start Date
January 2012 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nuwellis, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Cardiac Failure, Acute Decompensated Heart Failure (ADHF)
Keywords
Ultrafiltration, Aquapheresis, Diuretics, Loop Diuretics, Aquadex Flexflow System, Gambro UF Solutions
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
224 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aquapheresis (AQ) - isolated veno-venous ultrafiltration
Arm Type
Experimental
Arm Description
Excess fluid from the patient is removed by isolated veno-venous ultrafiltration treatment using the Aquadex Flex Flow System
Arm Title
IV Loop Diuretics (LD)
Arm Type
Active Comparator
Arm Description
Excess fluid from the patient is removed by IV (Intravenous) loop diuretic treatment
Intervention Type
Device
Intervention Name(s)
Isolated veno-venous ultrafiltration (AQ)
Other Intervention Name(s)
Aquapheresis, Ultrafiltration, Aquadex FlexFlow System, Gambro UF Solutions
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
IV Loop Diuretics (LD)
Other Intervention Name(s)
furosemide
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to First Heart Failure (HF) Event
Description
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
Time Frame
90 days after discharge from index HF hospitalization.
Secondary Outcome Measure Information:
Title
EFFICACY: Total Fluid Removed During the Index Hospitalization
Description
AQ-Fluid removed by AQ plus urine voided versus urine voided when treated with IV diuretics
Time Frame
Index Hospitalization, an average of 8 days
Title
EFFICACY: Net Fluid Removed During the Index Hospitalization
Description
AQ-Fluid removed by AQ plus urine voided minus fluid intake versus urine voided minus fluid intake with the IV diuretics.
Time Frame
Index Hospitalization, an average of 8 days
Title
EFFICACY: Weight Loss at 72 Hours After Initiation of Treatment
Description
Weight at 72 hours after treatment initiation minus weight at treatment initiation. Negative mean values indicate weight loss.
Time Frame
72 hours after treatment initiation
Title
EFFICACY: Total Weight Loss During the Index Hospitalization
Description
Weight at hospital discharge minus weight at hospital admission. Negative mean values indicate weight loss.
Time Frame
Index Hospitalization, an average of 8 days
Title
EFFICACY: Time to Freedom From Congestion
Description
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.
Time Frame
Index Hospitalization, an average of 8 days
Title
EFFICACY: Freedom From Congestion
Description
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
Time Frame
Index Hospitalization, an average of 8 days
Title
EFFICACY: Changes in B-type Natriuretic Peptide (BNP) Levels Over Time
Description
Change in BNP levels over time at 72 hours, discharge, and 90 days after discharge.
Time Frame
Baseline and at 72 hours from baseline, hospital discharge and at 90 days after hospital discharge
Title
Length of Stay (LOS) During the Index Hospitalization
Description
Number of days patient is in hospital for HF treatment.
Time Frame
Index hospitalization admission to index hospitalization discharge
Title
CLINICAL: Total Number of Days Rehospitalized for Heart Failure (HF) at 30 and 90 Days After Discharge
Description
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.
Time Frame
Within 30 days and 90 days after hospital discharge
Title
CLINICAL: Total Number of Emergency Department (ED) or Unscheduled Office Visits at 30 and 90 Days After Discharge
Description
Number of visits for HF symptoms requiring ED or clinic treatment involving the use of IV diuretics and /or positive inotropic or vasodilator drugs
Time Frame
Within 30 days and 90 days after hospital discharge
Title
CLINICAL: Total Number of Heart Failure (HF) Rehospitalizations at 30 and 90 Days After Discharge
Description
Number of different times patient was admitted to hospital for HF symptoms within 90 days of index hospitalization discharge.
Time Frame
Within 30 days and 90 days after hospital discharge
Title
CLINICAL: Total Number of Cardiovascular (CV) Rehospitalizations at 30 and 90 Days After Discharge
Description
CV symptoms that required hospitalization for treatment within 90 days of index hospitalization discharge.
Time Frame
Within 30 days and 90 days after hospital discharge
Title
CLINICAL: Total Number of Days for Cardiovascular (CV) Rehospitalizations at 30 and 90 Days After Discharge
Description
The total number of days spent in the hospital due to CV related events at 30 days and 90 days from hospital discharge.
Time Frame
Within 30 days and 90 days after hospital discharge
Title
CLINICAL: All Cause Rehospitalization Rates at 30 and 90 Days
Description
Any cause that required hospitalization for treatment within 90 days of index hospitalization discharge.
Time Frame
Within 30 days and 90 days after hospital discharge
Title
Mortality Rates Within Index Hospitalization or Within 90 Days After Hospital Discharge.
Description
Death due to any cause within index hospitalization and 90 days following hospital discharge.
Time Frame
Time from randomization to 90 days post-hospital discharge
Title
Days Alive and Out of Hospital at 30 and 90 Days After Discharge
Description
Number of days patients were alive and out of the hospital at 30 and 90 days after discharge.
Time Frame
Within 30 and 90 days after hospital discharge
Title
Quality of Life Assessed Using the Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30, 60 and 90 Days After Discharge
Description
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.
Time Frame
Within 90 days after hospital discharge
Title
CLINICAL: Global Clinical Score at 30 and 90 Days After Discharge
Description
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.
Time Frame
Within 90 days after hospital discharge
Title
SAFETY: Changes in Renal Function (Serum Creatinine) After Treatment up to 90 Days After Randomization
Description
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
Time Frame
Within 90 days of randomization
Title
SAFETY: Changes in Renal Function (Blood Urea Nitrogen) After Treatment up to 90 Days After Randomization
Description
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
Time Frame
Within 90 days of randomization
Title
SAFETY: Changes in Renal Function (Blood Urea Nitrogen/Serum Creatinine) After Treatment up to 90 Days After Randomization
Description
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
Time Frame
Within 90 days of randomization
Title
SAFETY: Changes in Renal Function (Estimated Glomerular Filtration Rate) After Treatment up to 90 Days After Randomization
Description
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
Time Frame
Within 90 days of randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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)
Exclusion Criteria:
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%
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Rosa Costanzo, MD
Organizational Affiliation
Midwest Heart Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart Center Research
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Mayo Clinic - Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Scottsdale Healthcare Research Institute
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California, San Diego (UCSD)
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
San Diego Cardiac Center
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Morton Plant Medical Center
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwestern University
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60208
Country
United States
Facility Name
Edward Hospital Center for Advanced Heart Failure
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60566
Country
United States
Facility Name
Advocate Health & Hospitals Corporation
City
Oakbrook Terrace
State/Province
Illinois
ZIP/Postal Code
60181
Country
United States
Facility Name
Elkhart General HealthCare
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46514
Country
United States
Facility Name
Northern Indiana Research Alliance
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
Iowa Health - Des Moines
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50316
Country
United States
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
Minneapolis VA Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Saint Luke's Hospital and Saint Luke's Cardiovascular Consultants
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
AtlantiCare Health Network
City
Egg Harbor Township
State/Province
New Jersey
ZIP/Postal Code
08234
Country
United States
Facility Name
New Mexico Heart Institute/Heart Hospital
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Asheville Cardiology Associates
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
MetroHealth Systems
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Good Samaritan Hospital - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Facility Name
Oklahoma Heart Institute and Hillcrest Medical Center
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
St. Luke's Hospital and Health Network
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18018
Country
United States
Facility Name
Drexel University College of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Albert Einstein Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
Saint Thomas Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Brooke Army Medical Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
Virginia Commonwealth University Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
MultiCare Health System/Tacoma General Hospital
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Aurora St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17291932
Citation
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. Erratum In: J Am Coll Cardiol. 2007 Mar 13;49(10):1136.
Results Reference
background
PubMed Identifier
15846257
Citation
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.
Results Reference
background
PubMed Identifier
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Study of Heart Failure Hospitalizations After Aquapheresis Therapy Compared to Intravenous (IV) Diuretic Treatment
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