DR REGISTRY: Prospective Observational Study of ADHF Patients With Insufficient Response to Diuretics

Study Overview
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Brief Summary
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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.

Official Title
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DR REGISTRY: Prospective Observational Study of Decongestion in Acute Heart Failure Patients With Insufficient Response to Diuretics

Conditions
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Acute Decompensated Heart Failure

Intervention / Treatment
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* Other: Standard of care


Participation Criteria
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Eligibility Criteria
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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: peripheral edema ≥ 2+ radiographic pulmonary edema or pleural effusion enlarged liver or ascites pulmonary rales or paroxysmal nocturnal dyspnea, or orthopnea Jugular venous distention > 7 cmH2O Subject insufficiently responds to IV diuretic therapy Exclusion Criteria: Systolic blood pressure <90 mmHg at the time of screening. Acute myocardial infarction or acute coronary syndrome or cardiogenic shock or pleural synthesis within past 7 days or cardiovascular intervention within past 4 days. Known LVEF < 15% by echocardiography within 1 year prior to enrolment. Complex congenital heart disease (e.g., Tetralogy of Fallot subjects, single ventricle physiology). Known active myocarditis, hypertrophic obstructive cardiomyopathy, constrictive pericarditis or cardiac tamponade. Severe Aortic valvular disorder (i.e., hemodynamically relevant valvular diseases such as severe stenosis \severe regurgitation) or Severe mitral disease with planned intervention. Evidence of active systemic infection documented by either one of the following: fever >38°C/100°F, or ongoing uncontrolled infection (i.e., inflammatory parameters not decreasing despite > 48 hours of antibiotic treatment). Moribund subject or subject with severe or deteriorating damage in more than 3 critical body systems, based on investigator's clinical judgement.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ADHF patients<br>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. | Other: Standard of care<br>* Standard medical treatment of ADHF patients deemed to have insufficient diuretic response.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHF