Please select the eligibility criteria that correspond to the clinical trial below.
Title: PURE-HF: Peripheral Ultrafiltration for the RElief From Congestion in Heart Failure
Brief Summary: This study evaluates whether tailored, peripheral ultrafiltration complementary to low-dose diuretics is associated with a reduction in cardiovascular mortality in 90 days after randomization and heart failure events in 90 days after discharge than usual care including stepped intravenous diuretics in acutely decompensated chronic heart failure with fluid overload (not fully responsive to diuretic therapy).


Options:
A: Inclusion criteria:

* age 18 or older
* admitted to the hospital with a primary diagnosis of decompensated heart failure
* onset of cardiorenal syndrome after hospitalization or pre-hospitalization
* after hospitalization - onset of cardiorenal syndrome after hospitalization must occur within 10 days from the time of admission after receiving IV diuretics
* pre-hospitalization - onset of cardiorenal syndrome pre-hospitalization must occur within 12 weeks of the index hospitalization in the setting of escalating doses of outpatient diuretics
* persistent volume overload

Exclusion criteria:

* intravascular volume depletion based on investigator"s clinical assessment
* acute coronary syndrome within 4 weeks
* indication for hemodialysis
* creatinine \> 3.5 mg per deciliter at admission to the hospital
* systolic blood pressure \< 90 mmHg at the time of enrollment
* alternative explanation for worsening renal function such as obstructive nephropathy,contrast induced nephropathy, acute tubular necrosis
* Hematocrit \> 45%
* poor venous access
* clinical instability likely to require the addition of intravenous vasoactive drugs including vasodilators and/or inotropic agents
* allergy or contraindications to the use of heparin
* the use of iodinated radio contrast material in the last 72 hours or anticipated use of IV contrast during the current hospitalization
* known bilateral renal artery stenosis
* active myocarditis
* hypertrophic obstructive cardiomyopathy
* severe valvular stenosis
* complex congenital heart disease
* sepsis or ongoing systemic infection
* enrollment in another clinical trial involving medical or device based interventions
B: Inclusion criteria

On admission (screening)

* Informed consent
* Age 18-80 years
* NYHA class III - IV
* Signs of pulmonary (pulmonary rales, and interstitial oedema or pleural effusion on chest Xray) and/or systemic congestion (pitting ankle oedema and enlarged liver or ascites and neck vein distension ≥ 7 cm) and weight gain ≥ 2 kg during the previous week
* Glomerular filtration rate ≥ 30 ml/min
* BNP increased \>400 pg/ml (diagnostic cut-off for ADCHF), as confirmatory diagnostic test)

  24 hours after admission (randomization)
* Persistent signs of pulmonary (pulmonary rales, interstitial oedema or pleural effusion on chest Xray) and/or systemic congestion (ankle oedema, enlarged liver or ascites, neck vein distension ≥ 7 cm)
* Serum creatinine or urine output criteria indicative of modified RIFLE (AKI: risk) class at least 1 (increase x 1.5 in serum creatinine or decrease \> 25% in GFR or urine output \< 0.5 ml/Kg/h for more than 6 hours) 29-30 during diuretic infusion

Exclusion criteria

* Chronic kidney disease stage 4-5 (GFR \< 30 ml/min)
* Acute coronary syndromes
* Systolic blood pressure \<90 mm Hg/need for intravenous inotropes
* Hematocrit \> 45%
* Unattainable venous access
* Contraindications to anticoagulation by heparin
* Systemic infection
* Heart transplant
C: Inclusion Criteria:

* Patients over 18 years;
* Patients with diagnosis of ADHF(dyspnea, orthopnea, peripheral edema or major fatigue and at least two clinical signs including rales, hepatomegaly, pulmonary congestion on chest radiography, jugular vein dilatation, or a third heart sound);
* Blood BNP \> 100 pg/mL;

ADHF: Acute Decompensated Heart Failure; BNP: B-type Natriuretic Peptide; IV: IntraVenous; LVEF: Left Ventricular Ejection Fraction.

Exclusion Criteria:

* Patients who receive more than 40 mg of IV furosemide;
* End-Stage renal disease or renal replacement therapy;
* Recent myocardial infarction (within thirty days of screening);
* Systolic blood pressure \< 80 mmHg;
* Creatinine levels \> 4 mg/dL;
* Patients affected by sepsis, liver diseases, inflammatory diseases or neoplastic diseases.
D: 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

Answer: D