The MetroHealth System

Condition

• Acute Decompensated Heart Failure

Eligibility

Eligible Ages

Over 18 Years

Eligible Genders

All

Accepts Healthy Volunteers

No

Criteria

INCLUSION.

1. Subject is >18 years of age.

2. Subject is hospitalized with primary diagnosis of ADHF.

3. N-terminal-pro-brain natriuretic peptide (NT-proBNP) ≥1,000 pg/m or BNP≥250 pg/mL
for body-mass index (BMI) ≤25.

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. IVCCI < 50% by cardiac ultrasonography or elevated CVP (or RAP) ≥12 mmHg (Invasively
measured).

6. Subject insufficiently responds to IV diuretic therapy defined as average hourly
urine output <125ml/hour over 6 hours OR cumulative urine output < 3L over 24 hours
OR a Net Fluid Loss <375mL in a 12-hour timeframe following ≥2 diuretic challenges
with a minimum of:

1. 1st diuretic dose: ≥2X chronic oral daily dose (IV) or 80 mg IV Lasix or
equivalent.

2. 2nd diuretic dose: ≥ 80 mg IV Lasix or equivalent.

7. Females who are not pregnant or lactating and not planning to become pregnant for
the duration of the study. Females of child-bearing potential must have a negative
pregnancy test.

Procedural Inclusion Criterion

8. CVP (or RAP) ≥12 mmHg and PCWP ≥ 18 mmHg confirmed in the Cath Lab, via femoral
line, pigtail, Swan Ganz, or other indwelling catheter.

EXCLUSION

1. Systolic blood pressure <90 mmHg at the time of screening.

2. Acute myocardial infarction or acute coronary syndrome or cardiogenic shock or
pleurocentesis within past 14 days or cardiovascular intervention within past 14
days.

3. Known LVEF < 10% by echocardiography within 1 year prior to enrollment.

4. Complex congenital heart disease (e.g., Tetralogy of Fallot subjects, single
ventricle physiology).

5. Known active myocarditis, hypertrophic obstructive cardiomyopathy, infiltrative
cardiomyopathy (e.g., amyloidosis), 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. Subject has severe renal dysfunction, defined as either eGFR <25 ml/min/1.73 m2 BSA
on admission or on renal replacement therapy.

8. Subject with advanced liver disease: either Total Bilirubin > 4 mg/dL or Serum
sodium (corrected for glucose) < 125 mmol/L.

9. Treatment with high dose IV inotropes within 2 days prior to enrollment. High dose
is defined as > 1 unit of inotrope (excluding Digoxin) as follows: 5 µg/kg/min
dopamine = 1 unit, 5 µg/kg/min dobutamine= 1 unit, 0.375 µg/kg/min milrinone = 1
unit.

10. Subject with a history of:

1. Deep vein thrombosis that occurred < 6 months prior to enrollment, and/or;

2. Pulmonary embolism episode that occurred < 6 months prior to enrollment.

11. 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 hrs of antibiotic treatment).

12. Subjects with a known infra-renal IVC diameter of <16mm.

13. Moribund subject or subject with severe or deteriorating damage in more than 3
critical body systems, based on investigator's clinical judgement.

Recruiting Locations

Study Contact