Last updated on June 2019

EntrestoTM (LCZ696) In Advanced Heart Failure (LIFE Study)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Heart failure
  • Age: Between 18 - 85 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. Advanced HFrEF defined as including ALL
  2. LVEF 35% documented during the preceding 12 months
  3. NYHA class IV symptomatology, defined as chronic dyspnea or fatigue at rest or on minimal exertion in the previous 3 months, or patients who require chronic inotropic therapy
  4. Minimum of 3 months GDMT for HF and/or intolerant to therapy
  5. Systolic blood pressure 90 mmHg
  6. Serum NT-proBNP 800 pg/mL OR BNP 250 pg/mL (most recent - less than 3 months old)
  7. Any one or more of the following objective findings of advanced HF including:
  8. Current inotropic therapy or use of inotropes in the past 6 months
  9. 1 hospitalization for heart failure in the past 6 months (not including the index hospitalization for inpatient participants)
  10. LVEF 25% (within the past 12 months)
  11. Peak VO2 < 55% predicted or peak VO2 16 for men or 14 for women (Respiratory Exchange Ratio (RER) 1.05) (within the past 12 months)
  12. 6 min walk test distance < 300 m (within the past 3 months)
  13. Age 18 years and 85 years
  14. Signed Informed Consent form

Exclusion Criteria:

  1. Currently taking Entresto
  2. History of hypersensitivity or intolerance (unmodifiable) to Entresto, an ACEI or ARB as well as known or suspected contraindications (including hereditary angioedema) to the study drugs.
  3. Estimated glomerular filtration rate (eGFR) < 20 mL/min/1.73 m2 at baseline
  4. Co-morbid conditions that may interfere with completing the study protocol (e.g. recent history of drug or alcohol abuse) or cause death within 1 year
  5. Symptomatic hypotension at randomization or systolic blood pressure < 90 mmHg
  6. Serum potassium > 5.5 mmol/L
  7. Severe liver dysfunction (Childs-Pugh Class C)
  8. Acute coronary syndrome within 4 weeks as defined by electrocardiographic (ECG) changes and biomarkers of myocardial necrosis (e.g. troponin) in an appropriate clinical setting (chest discomfort or anginal equivalent)
  9. Planned or recent ( 4 weeks) PCI, coronary artery bypass grafting, or biventricular pacing
  10. Currently hospitalized and listed status 1A, 1B or 1-4 for heart transplant
  11. Current or scheduled for LVAD implantation within 30 days of study enrollment
  12. Active infection (current use of oral or IV antimicrobial agents)
  13. Primary hypertrophic or infiltrative cardiomyopathy, acute myocarditis, constrictive pericarditis or tamponade
  14. Complex congenital heart disease
  15. Concomitant use of aliskiren in patients with diabetes or renal impairment (eGFR <60 mL/min/1.73 m)
  16. Known pregnancy or anticipated pregnancy within the next 6 months or breastfeeding mothers
  17. Enrollment in any other investigational clinical trial within 30 days prior to screening
  18. Inability to comply with study procedures

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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