PURE-HF: Peripheral Ultrafiltration for the RElief From Congestion in Heart Failure

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