Please select the eligibility criteria that correspond to the clinical trial below.
Title: Ultrafiltration for the Chronic Treatment of Severe Congestive Heart Failure
Brief Summary: Patients with severe congestive heart failure show increased fluid body content which is often resistant to conventional diuretic therapy. Therefore, chronic heart failure patients have frequent access to the emergency room and hospital for hemodynamic instability. Ultrafiltration is a simple renal replacement therapy which reduces fluid overload. The purpose of this study is to determine whether periodic ultrafiltration sessions maintain patients in stable clinical condition and reduce hospitalisations as well as access to emergency heart failure treatment.


Options:
A: Inclusion Criteria:

* 2 of 3 physical exam findings of volume overload (rales, JVP over 5 cm and edema)
* BNP over 300
* no contraindication to ultrafiltration (line insertion, heparin use)

Exclusion Criteria:

* serum creatinine \> 3mg/dL or Na \> 145
* inotrope or vasopressor dependency
* active infection, including urinary tract
* resynchronization therapy or coronary intervention in past 30 days
* life expectancy less than 6 months
* hypertrophic obstructive cardiomyopathy with peak resting gradient \> 20 mmHg
* IV contrast or NSAID use in the past 1 week (uNGAL related requirement)
B: 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
C: 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
D: Inclusion Criteria:

* Severe heart failure (NYHA III-IV) with fluid overload
* Ejection fraction \< 40%
* Estimated fluid overload \> 4 kg

Exclusion Criteria:

* Severe renal insufficiency
* Acute pulmonary edema and/or cardiogenic shock

Answer: D