DR REGISTRY: Prospective Observational Study of ADHF Patients With Insufficient Response to Diuretics
Completed
Conditions studied: Acute Decompensated Heart Failure
In brief
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.
Key facts
- Study ID
- NCT04877652
- Run by
- Revamp Medical Ltd.
- People needed
- 6
- Starts
- 2021-11-17
- Expected to finish
- 2022-05-25
- Last updated by the study team
- 2022-05-26
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Weill Cornell — New York, New York, United States
- Columbia University Irving Medical Center — New York, New York, United States
- Montefiore Medical Center - Moses Campus — New York, New York, United States
- St Francis Hospital — New York, New York, United States
Full record on ClinicalTrials.gov
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