Clinical trial NCT04877652: DR REGISTRY: Prospective Observational Study of ADHF Patients With Insufficient Response to Diuretics
Official title: DR REGISTRY: Prospective Observational Study of Decongestion in Acute Heart Failure Patients With Insufficient Response to Diuretics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Decompensated Heart Failure
Keywords: ADHF
Lead sponsor: Revamp Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2021-05-07
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute Heart Failure Patients with Insufficient Response to Diuretics

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.


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.

Primary outcomes:
measure: Serious Adverse Events
timeFrame: 30 days
measure: Serum Creatinine
timeFrame: Baseline [T=0] and 48 hours
measure: Urine Output
timeFrame: Baseline [T=0-12h] and through 24 hours [T=12-36h]
Secondary outcomes:
Other outcomes:
measure: Dyspnea
timeFrame: Baseline [T=0] and 48 hours
measure: Peripheral Edema
timeFrame: Baseline [T=0] and 48 hours
measure: Length of hospitalization
timeFrame: through follow-up period completion (up to 60 days)
measure: Heart Failure Readmission
timeFrame: Baseline through 30 days
Locations:
city: New York
country: United States
facility: Weill Cornell
state: New York
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: New York
country: United States
facility: Montefiore Medical Center - Moses Campus
state: New York
city: New York
country: United States
facility: St Francis Hospital
state: New York
Study officials:
References: