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.
Brief Title
DR REGISTRY: Prospective Observational Study of ADHF Patients With Insufficient Response to Diuretics
Categories
Completion Date
Completion Date Type
Actual
Conditions
Acute Decompensated Heart Failure
Eligibility Criteria
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.
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.
Inclusion Criteria
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
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
Gender
All
Gender Based
false
Keywords
ADHF
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
85 Years
Minimum Age
18 Years
NCT Id
NCT04877652
Org Class
Industry
Org Full Name
Revamp Medical Ltd.
Org Study Id
CIS-D-02
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
DR REGISTRY: Prospective Observational Study of Decongestion in Acute Heart Failure Patients With Insufficient Response to Diuretics
Primary Outcomes
Outcome Description
SAEs (including MACE) post enrollment based on CEC adjudication.
Outcome Measure
Serious Adverse Events
Outcome Time Frame
30 days
Outcome Description
Change in level
Outcome Measure
Serum Creatinine
Outcome Time Frame
Baseline [T=0] and 48 hours
Outcome Description
Change in the rate
Outcome Measure
Urine Output
Outcome Time Frame
Baseline [T=0-12h] and through 24 hours [T=12-36h]
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
Acute Heart Failure Patients with Insufficient Response to Diuretics
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
85
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Daniel Sims
Investigator Email
dsims@montefiore.org
Investigator Phone
MeSH Terms
STANDARD OF CARE
QUALITY INDICATORS, HEALTH CARE
QUALITY OF HEALTH CARE
HEALTH SERVICES ADMINISTRATION
HEALTH CARE QUALITY, ACCESS, AND EVALUATION