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The study objective is to observe and measure clinical outcomes, urine output, and safety events occurring during standard medical treatment of ADHF patients deemed to have insufficient diuretic response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADHF patients | Patients with acute decompensated heart failure (ADHF) having insufficient response to diuretic therapy following a dose escalation protocol in keeping with AHA guidelines for the management of heart failure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of care | Other | Standard medical treatment of ADHF patients deemed to have insufficient diuretic response. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serious Adverse Events | SAEs (including MACE) post enrollment based on CEC adjudication. | 30 days |
| Serum Creatinine | Change in level | Baseline [T=0] and 48 hours |
| Urine Output | Change in the rate | Baseline [T=0-12h] and through 24 hours [T=12-36h] |
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| Measure | Description | Time Frame |
|---|---|---|
| Dyspnea | Change in dyspnea score using the Likert scale (score ranges from -3 to +3, higher score means better improvement) | Baseline [T=0] and 48 hours |
| Peripheral Edema | Change in score (ranges from none/0 to +4) |
Inclusion Criteria:
Subject is >18 and < 85 years of age.
Subject is hospitalized with primary diagnosis of ADHF.
N-terminal-pro-brain natriuretic peptide (NT-proBNP) ≥1,600 pg/m or BNP≥400 pg/mL.
Evidence of fluid overload as indicated by 2 or more of the following criteria:
Subject insufficiently responds to IV diuretic therapy
Exclusion Criteria:
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Acute Heart Failure Patients with Insufficient Response to Diuretics
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell | New York | New York | 10021 | United States | ||
| Columbia University Irving Medical Center |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Baseline [T=0] and 48 hours |
| Length of hospitalization | Length of current hospitalization (resolution of acute heart failure condition) | through follow-up period completion (up to 60 days) |
| Heart Failure Readmission | Time to readmission due to HF, up to 30 days | Baseline through 30 days |
| New York |
| New York |
| 10032 |
| United States |
| Montefiore Medical Center - Moses Campus | New York | New York | 10461 | United States |
| St Francis Hospital | New York | New York | 11576 | United States |