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

This is an interventional treatment trial for Heart Failure focused on measuring Cardio-Renal Syndrome type 1, Acutely decompensated chronic heart failure, Ultrafiltration Read More

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