Acute Decompensated Heart Failure
Conditions
Keywords
ADHF
Brief summary
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.
Interventions
OTHERStandard of care
Standard medical treatment of ADHF patients deemed to have insufficient diuretic response.
Sponsors
Revamp Medical Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Subject is \>18 and \< 85 years of age. 2. Subject is hospitalized with primary diagnosis of ADHF. 3. N-terminal-pro-brain natriuretic peptide (NT-proBNP) ≥1,600 pg/m or BNP≥400 pg/mL. 4. Evidence of fluid overload as indicated by 2 or more of the following criteria: 1. peripheral edema ≥ 2+ 2. radiographic pulmonary edema or pleural effusion 3. enlarged liver or ascites 4. pulmonary rales or paroxysmal nocturnal dyspnea, or orthopnea 5. Jugular venous distention \> 7 cmH2O 5. Subject insufficiently responds to IV diuretic therapy
Exclusion criteria
1. Systolic blood pressure \<90 mmHg at the time of screening. 2. Acute myocardial infarction or acute coronary syndrome or cardiogenic shock or pleural synthesis within past 7 days or cardiovascular intervention within past 4 days. 3. Known LVEF \< 15% by echocardiography within 1 year prior to enrolment. 4. Complex congenital heart disease (e.g., Tetralogy of Fallot subjects, single ventricle physiology). 5. Known active myocarditis, hypertrophic obstructive cardiomyopathy, constrictive pericarditis or cardiac tamponade. 6. Severe Aortic valvular disorder (i.e., hemodynamically relevant valvular diseases such as severe stenosis \\severe regurgitation) or Severe mitral disease with planned intervention. 7. 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). 8. Moribund subject or subject with severe or deteriorating damage in more than 3 critical body systems, based on investigator's clinical judgement.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serious Adverse Events | 30 days | SAEs (including MACE) post enrollment based on CEC adjudication. |
| Serum Creatinine | Baseline [T=0] and 48 hours | Change in level |
| Urine Output | Baseline [T=0-12h] and through 24 hours [T=12-36h] | Change in the rate |
Other
| Measure | Time frame | Description |
|---|---|---|
| Dyspnea | Baseline [T=0] and 48 hours | Change in dyspnea score using the Likert scale (score ranges from -3 to +3, higher score means better improvement) |
| Heart Failure Readmission | Baseline through 30 days | Time to readmission due to HF, up to 30 days |
| Peripheral Edema | Baseline [T=0] and 48 hours | Change in score (ranges from none/0 to +4) |
| Length of hospitalization | through follow-up period completion (up to 60 days) | Length of current hospitalization (resolution of acute heart failure condition) |
Countries
United States
Outcome results
None listed