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

Completed · Phase 4 · Has a placebo group

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT02816736

Run by

Duke University

People needed

365

Starts

2017-03-02

Expected to finish

2020-09-29

Last updated by the study team

2021-12-03

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Advanced HFrEF defined as including ALL
• LVEF≤ 35% documented during the preceding 12 months
• 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
• Minimum of 3 months GDMT for HF and/or intolerant to therapy
• Systolic blood pressure ≥ 90 mmHg
• Serum NT-proBNP ≥ 800 pg/mL OR BNP ≥ 250 pg/mL (most recent - less than 3 months old)
• Any one or more of the following objective findings of advanced HF including:
• Current inotropic therapy or use of inotropes in the past 6 months
• ≥ 1 hospitalization for heart failure in the past 6 months (not including the index hospitalization for inpatient participants)
• LVEF ≤ 25% (within the past 12 months)
• 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 min walk test distance < 300 m (within the past 3 months)
• Age ≥18 years and ≤ 85 years
• Signed Informed Consent form

You may not qualify if…

• Currently taking Entresto™
• 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.
• Estimated glomerular filtration rate (eGFR) < 20 mL/min/1.73 m2 at baseline
• 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
• Symptomatic hypotension at randomization or systolic blood pressure < 90 mmHg
• Serum potassium > 5.5 mmol/L
• Severe liver dysfunction (Childs-Pugh Class C)
• 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)
• Planned or recent (≤ 4 weeks) PCI, coronary artery bypass grafting, or biventricular pacing
• Currently hospitalized and listed status 1A, 1B or 1-4 for heart transplant
• Current or scheduled for LVAD implantation within 30 days of study enrollment
• Active infection (current use of oral or IV antimicrobial agents)
• Primary hypertrophic or infiltrative cardiomyopathy, acute myocarditis, constrictive pericarditis or tamponade
• Complex congenital heart disease
• Concomitant use of aliskiren in patients with diabetes or renal impairment (eGFR <60 mL/min/1.73 m²)
• Known pregnancy or anticipated pregnancy within the next 6 months or breastfeeding mothers
• Enrollment in any other investigational clinical trial within 30 days prior to screening
• Inability to comply with study procedures

Where it is running

• Cedars-Sinai Heart Institute — Beverly Hills, California, United States
• Sutter Health Mills-Peninsula Health Services — Sacramento, California, United States
• San Diego Cardiac Center — San Diego, California, United States
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Piedmont Heart Institute — Atlanta, Georgia, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• Advocate Christ Medical Center — Oak Lawn, Illinois, United States
• St. Vincent Medical Group — Indianapolis, Indiana, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• Saint Louis University Hospital — St Louis, Missouri, United States
• Mount Sinai Hospital — New York, New York, United States
• Stony Brook University Medical Center — Stony Brook, New York, United States
• Charlotte-Mecklenburg Hospital Authority — Charlotte, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• The Christ Hospital — Cincinnati, Ohio, United States
• Case Western Medical Center — Cleveland, Ohio, United States
• Metro Health System — Cleveland, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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