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Active Clinical Trials

LIFE Study

Active NCT:
02816736
Allegheny General Hospital
Allegheny General Hospital

Sponsor: 
Supported by the National, Heart, Lung and Blood Institute of the National Institutes of Health under award U10HL084904
Contact: 

For more information, please contact Gayatri Chatragadda at 412-359-3285 or Gayatri.Chatragadda@AHN.ORG

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

Purpose: 

The primary objective of the study is to determine whether, in patients with symptomatic, advanced heart failure due to left ventricular systolic dysfunction, treatment with LCZ696 for 24 weeks will improve Pro-B-type Natriuretic Peptide (NT-proBNP) levels, which reflect hemodynamic and clinical status, compared to treatment with valsartan.

Ages Eligible for Study: 18 Years to 85 Years (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:

  1. Advanced HFrEF defined as including ALL
    1. LVEF≤ 35% documented during the preceding 3 months
    2. estimated GFR 20-60 mL/min/1.73m2
    3. Current or prior (within the last 3 months) NYHA class IV symptomatology (INTERMACS profile 3-4)
    4. Minimum of 3 months GDMT for HF and/or intolerant to therapy
  2. HF ≥1 symptom (dyspnea, orthopnea, or edema) and ≥ 1 sign of congestion (rales on auscultation, ascites, peripheral edema, or pulmonary vascular congestion on chest radiography)
  3. Systolic blood pressure ≥ 90 mmHg
  4. Serum NT-proBNP ≥ 800 pg/mL OR BNP ≥ 250 pg/mL (most recent and within the last year)
  5. Any one or more of the following objective findings of advanced HF including:
    1. Inotropic therapy currently, or for ≥ 5 days in the past 6 months
    2. ≥ 1 hospitalizations for heart failure in the past 6 months (not including the index hospitalization for inpatient subjects.)
    3. LVEF ≤ 25% (within the past 3 months)
    4. PCW or LVEDP ≥ 20 mmHg (within the past 3 months)
    5. 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)
    6. 6 min walk test distance < 300 m (within the past 3 months)
    7. Estimated GFR < 45 mL/min/1.73 m² as measured by the simplified MDRD formula (within the past 12 months)
    8. History of an intraaortic balloon pump placement within the past 6 months
  6. Signed Informed Consent form

 

Exclusion Criteria:

  1. Currently taking Entresto™
  2. History of hypersensitivity or intolerance to Entresto™, an ACEI or ARB as well as known or suspected contraindications to the study drugs.
  3. Age < 18 years or > 85 years; co-morbid conditions that may cause death within 1 yr (e.g. cancer, chronic obstructive pulmonary disease (COPD)); and recent history of drug abuse.
  4. Symptomatic hypotension at randomization.
  5. Serum potassium > 5.5 mmol/L
  6. Severe liver dysfunction (Childs-Pugh Class C)
  7. 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)
  8. Planned or recent (≤ 4 weeks) PCI, coronary artery bypass grafting, or biventricular pacing
  9. Currently hospitalized and listed 1A or 1B for transplant
  10. Current or scheduled for LVAD implantation within 30 days of study enrollment
  11. Active infection (current use of oral or IV antimicrobial agents)
  12. Primary hypertrophic or infiltrative cardiomyopathy, acute myocarditis, constrictive pericarditis or tamponade
  13. Complex congenital heart disease
  14. Known pregnancy or anticipated pregnancy within the next 6 months or breastfeeding mothers
  15. Enrollment in any other investigational clinical trial within 30 days prior to screening
  16. Inability to comply with study procedures