Please select the eligibility criteria that correspond to the clinical trial below.
Title: Ultrafiltration Versus IV Diuretics for Patients Hospitalized for Acute Decompensated Heart Failure: A Prospective Randomized Clinical Trial
Brief Summary: The purpose of this study is to compare patients who are suffering from heart failure and who are fluid overloaded to determine if ultrafiltration (UF) can remove more of the extra fluid as measured by weight loss while in the hospital and improve the patient's breathing.


Options:
A: Inclusion criteria:

* Hospitalized for episode of worsening heart failure as primary cause of admission or significant heart failure symptoms that develop during the hospitalization when the initial reason for admission was not heart failure.
* Systolic dysfunction (LVEF \< 40%) or heart failure symptoms in the setting of preserved systolic function (diastolic dysfunction).

Exclusion criteria:

* This study has no exclusion criteria.
B: Key Inclusion Criteria:

* Male or female 18 years of age, with body weight ≤160 kg
* Hospitalized for AHF with anticipated requirement of IV therapy for at least 48 hours; AHF is defined as including all of the following measured at any time between presentation (including the emergency department) and the end of screening:

  * Persistent dyspnea at rest or with minimal exertion
  * Pulmonary congestion on chest radiograph
  * B-type natriuretic peptide (BNP) ≥500 pg/mL or N-terminal (NT)-proBNP ≥2000 pg/mL; for patients ≥ 75 years of age or with current atrial fibrillation (at the time of randomization), BNP ≥ 750 pg/mL or NT-proBNP ≥ 3,000 pg/mL
* Systolic BP ≥125 mmHg at the start and at the end of screening
* Able to be randomized within 16 hours from presentation to the hospital, including the emergency department
* Received intravenous furosemide of at least 40 mg total (or equivalent) at any time between presentation (this includes outpatient clinic, ambulance, or hospital including emergency department) and the start of screening for the study for the treatment of the current acute HF episode.

Key Exclusion Criteria:

* Dyspnea primarily due to non-cardiac causes
* Known history of respiratory disorders requiring the daily use of IV or oral steroids (does not include inhaled steroids); need for intubation or the current use of IV or oral steroids for chronic obstructive pulmonary disease (COPD)
* Temperature \>38.5°C (oral or equivalent) or sepsis or active infection requiring IV anti-microbial treatment
* Clinical evidence of acute coronary syndrome currently or within 30 days prior to enrollment.
* AHF due to significant arrhythmias, which include any of the following: sustained ventricular tachycardia, bradycardia with sustained ventricular rate \<45 beats per minute, or atrial fibrillation/flutter with sustained ventricular response of \>130 beats per minute
* Patients with severe renal impairment defined as pre-randomization estimated glomerular filtration rate (eGFR) \< 25 mL/min/1.73m2 calculated using the Simplified Modification of Diet in Renal Disease (sMDRD) equation, and/or those receiving current or planned dialysis or ultrafiltration
* Patients with hematocrit \<25%, or a history of blood transfusion within the 14 days prior to screening, or active life-threatening GI bleeding.
* Known hepatic impairment (as evidenced by total bilirubin \> 3 mg/dL, or increased ammonia levels, if performed) or history of cirrhosis with evidence of portal hypertension such as varices.
* Significant, uncorrected, left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy or severe aortic stenosis (i.e., aortic valve area \<1.0 cm2 or mean gradient \>40 mmHg on prior or current echocardiogram), and severe mitral stenosis
* Severe aortic insufficiency or severe mitral regurgitation for which surgical or percutaneous intervention is indicated.
* Documented, prior to or at the time of randomization, restrictive amyloid myocardiopathy, OR acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (does NOT include restrictive mitral filling patterns seen on Doppler echocardiographic assessments of diastolic function).
C: Inclusion Criteria:

General:

Informed consent signed and dated by study patient and investigator/authorised physician

* Minimum age of 18 years
* Ability to understand the nature and requirements of the study

Study-specific:

* Heart failure patients with preserved, mid-range or reduced ejection fraction (confirmed according to the current definitions of heart failure with preserved (HFpEF), mid-range (HFmrEF) and reduced ejection fraction (HFrEF) requiring echocardiographic assessment within the prior 12 months) who are admitted to the hospital due to signs/symptoms of congestion (left- or right sided)
* On regularly scheduled oral loop diuretics prior to admission
* Patients who have received IV loop diuretics for decongestion within 24 hours after hospital admission and prior to screening. The dosages are administered according to clinical judgment.\*\* (\*\*This inclusion criterion was changed with CIP amendment; in former version 3.0 it read "After pre-screening and prior to final screening for eligibility, patients who have received two boluses of IV loop diuretics (Dose according to the Furosemide-Low Intensification, Q12 hour bolus arm of the DOSE trial))
* Symptoms of congestion and clinical evidence at the time of final screening for eligibility:
* Fluid overload manifested by at least 2 of the following:

  1. Pitting edema ≥2+ of the lower extremities
  2. Jugular venous pressure \>8 cm H2O
  3. Pulmonary congestion or pleural effusion on chest x-ray
  4. Paroxysmal nocturnal dyspnea or ≥2- pillow orthopnea
  5. Respiration rate ≥20 per minute
* Additional objective documentation of congestion: Lung or inferior vena cava ultrasound, chest x-ray or elevated filling pressures, if available, at the time of randomization (optional)

Exclusion Criteria:

General:

* Any condition which could interfere with the patient's ability to comply with the study
* In case of female patients, pregnancy or lactation period
* Participation in an interventional clinical study during the preceding 30 days
* Previous participation in the same study
* Unwillingness or inability to complete follow up
* Active drug or alcohol abuse (smoking allowed)

Study-specific:

* Acute coronary syndrome requiring intervention during index hospitalization
* Severe renal dysfunction requiring renal replacement therapy
* Systolic blood pressure \< 90 mmHg at the time of randomization
* Pulmonary hypertension not secondary to left heart disease
* Pulmonary disease thought to be primarily responsible for symptoms
* Contraindication to systemic anticoagulation
* Severe concomitant disease expected to prolong hospitalization or to cause death in ≤ 90 days
* Sepsis
* Severe uncorrected valvular stenosis at the time of randomization
* Active myocarditis
* Hypertrophic obstructive cardiomyopathy
* Constrictive pericarditis or restrictive cardiomyopathy
* Liver cirrhosis due to primary liver disease\* (\*Restriction "due to primary liver disease" was present after amendment in study protocol version 5.0 but not in version 3.0)
* Known infection with human immunodeficiency virus (HIV) or active hepatitis C
* Previous solid organ transplant
* Presence or requirement for mechanical respiratory support
* Presence or requirement of a mechanical circulatory support device
* Need for IV positive inotropic agents at the time of randomization
D: Inclusion Criteria:

* Patients hospitalized with primary diagnosis of acute decompensated congestive heart failure (adCHF)
* Evidence of fluid overload as indicated by:

  1. pitting edema (2+) of lower extremities;
  2. jugular venous distension;
  3. pulmonary edema or pleural effusion;
  4. ascites;
  5. paroxysmal nocturnal dyspnea or 2-pillow orthopnea

Exclusion Criteria:

* Acute coronary syndrome
* Creatinine greater than 3.0
* Systolic blood pressure less than or equal to 90 mmHg
* Hematocrit greater than 45%
* Prior administration of IV vasoactive drugs in the emergency room (ER)
* Clinical instability requiring pressors during hospitalization
* Recent use of iodinated contrast material
* Severe concomitant disease expected to prolong hospitalization
* Sepsis
* On or requires renal dialysis
* Had a cardiac transplant
* Heparin allergy

Answer: D