Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the ability of Ultrafiltration to influence the rate of hemodynamic improvement, as measured by the decline in the pulmonary artery occlusion pressure, in patients with NYHA class III/IV Heart Failure.
This study will be preformed in a specialized heart failure unit at the Cleveland Clinic Foundation (CCF) and will include both the UF-treated group and a control group receiving usual and customary care. Patients will be stratified according to renal function at the time of admission. Therapies will be guided by specific hemodynamic criteria routinely used at the study institution.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrafiltration | Active Comparator | Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure. |
|
| Usual & Customary | Active Comparator | Patients treated with conventional diuretic therapy upon hospital admission for treatment of decompensated heart failure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV loop diuretic | Drug | Use of conventional diuretic therapy upon hospital admission for treatment of decompensated heart failure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time Required for the Pulmonary Artery Occlusion Pressure (PAOP) to be Maintained at a Value of Less Than or Equal to 18 mmHg for at Least Four Consecutive Hours (+/- 30 Minutes) During the Intervention Period. | 4 consecutive hours (+/- 30 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Discharge From the Heart Failure (HF) Unit, and Time to Discharge From the Hospital. | Time from admission to endpoint achievement | |
| Total Volume Removal During the Intervention Period | Intervention start to end. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alan Hull, MD | NxStage Medical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22277179 | Result | Hanna MA, Tang WH, Teo BW, O'Neill JO, Weinstein DM, Lau SM, Van Lente F, Starling RC, Paganini EP, Taylor DO. Extracorporeal ultrafiltration vs. conventional diuretic therapy in advanced decompensated heart failure. Congest Heart Fail. 2012 Jan-Feb;18(1):54-63. doi: 10.1111/j.1751-7133.2011.00231.x. Epub 2011 Jul 20. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ultrafiltration | Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure. |
| FG001 | Usual & Customary Care | Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ultrafiltration | Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure. |
| BG001 | Usual & Customary Care | Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time Required for the Pulmonary Artery Occlusion Pressure (PAOP) to be Maintained at a Value of Less Than or Equal to 18 mmHg for at Least Four Consecutive Hours (+/- 30 Minutes) During the Intervention Period. | Analysis was performed on the intent-to-treat group which consisted of all patients enrolled in this study. | Posted | Mean | Standard Deviation | hours | 4 consecutive hours (+/- 30 minutes) |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ultrafiltration | Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death (Cardiac reason) | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leighann Cesar, RN | Cleveland Clinic Foundation | 216-445-6551 | cesar1@ccf.org |
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D049994 | Sodium Potassium Chloride Symporter Inhibitors |
| ID | Term |
|---|---|
| D049990 | Membrane Transport Modulators |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| NxStage System One | Device | Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure. |
|
| Volume Removal Rate. | Hours of therapy required to remove 1 liter of fluid normalized to body weight. | Intervention start to end. |
| Composite Endpoint of Hospital Readmissions, Emergency Department Visits, and Deaths | Number of patients experiencing at least one of the composite endpoint measures within 90 days of hospital discharge. | Hospital discharge to 90 days after discharge |
| Adverse Event |
|
| Physician Decision |
|
| Severe Aortic Stenosis |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Glomerular Filtration Rate (GFR) | Number | Participants |
|
|
|
| Secondary | Time to Discharge From the Heart Failure (HF) Unit, and Time to Discharge From the Hospital. | The analysis population was the intent-to-treat group, represented by all patients enrolled in this study. | Posted | Mean | Standard Deviation | Days | Time from admission to endpoint achievement |
|
|
|
| Secondary | Total Volume Removal During the Intervention Period | The analysis population is the intent-to-treat group which includes all patients enrolled on the study. | Posted | Mean | Standard Deviation | milliliters | Intervention start to end. |
|
|
|
| Secondary | Volume Removal Rate. | Hours of therapy required to remove 1 liter of fluid normalized to body weight. | The analysis population is the intent-to-treat group which includes all patients enrolled on the study. | Posted | Mean | Standard Deviation | milliliters/hour/kilogram | Intervention start to end. |
|
|
|
| Secondary | Composite Endpoint of Hospital Readmissions, Emergency Department Visits, and Deaths | Number of patients experiencing at least one of the composite endpoint measures within 90 days of hospital discharge. | The analysis population is the intent-to-treat group which includes all patients enrolled on the study. | Posted | Number | participants | Hospital discharge to 90 days after discharge |
|
|
|
| 4 |
| 19 |
| 19 |
| 19 |
| EG001 | Usual & Customary Care | Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure. | 4 | 17 | 17 | 17 |
| Death (Infection-related) | Infections and infestations | Non-systematic Assessment |
|
| Chest Pain | Cardiac disorders | Non-systematic Assessment |
|
| Brady Arrhythmia | Cardiac disorders | Non-systematic Assessment |
|
| Claudication | Vascular disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Cramping | General disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Fever > 37.3 C | General disorders | Non-systematic Assessment |
|
| Headache | General disorders | Non-systematic Assessment |
|
| Hypoglycemic Episode | Endocrine disorders | Non-systematic Assessment |
|
| Hypotensive Episode | Renal and urinary disorders | Non-systematic Assessment |
|
| Infection | Infections and infestations | Non-systematic Assessment |
|
| Insomnia | General disorders | Non-systematic Assessment |
|
| Nausea | General disorders | Non-systematic Assessment |
|
| Other | General disorders | Non-systematic Assessment |
|
| Painful Access | Vascular disorders | Non-systematic Assessment |
|
| Worsening Heart Failure | Cardiac disorders | Non-systematic Assessment |
|
| Worsening Renal Failure | Renal and urinary disorders | Non-systematic Assessment |
|
Not provided
Not provided
| D004232 | Diuretics |
| D045283 | Natriuretic Agents |
| D045505 | Physiological Effects of Drugs |