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LIFE


Title Entrestotm (LCZ696) In Advanced Heart Failure (LIFE Study) (HFN-LIFE)
Therapeutic Area Cardiac Failure, Cardiovascular Disease, Heart Failure, Cardiomyopathy
Principal Investigator Michael Kiernan, MD
Min Age 18 Years
Max Age 85 Years
Gender All
Contact Nathan Yuen
617 636 4990
More Information https://clinicaltrials.gov/ct2/show/NCT02816736

Overview

The purpose of this study is to test whether EntrestoTM, a newly approved drug for heart failure that combines sacubitril and valsartan, improves symptoms and outcomes in persons with advanced heart failure in comparison to treatment with valsartan alone over 24 weeks. EntrestoTM has been studied in only a very small number of patients with advanced heart failure, like you. This study is beind done to obtain more information on the benefits and risks of EntrestoTM in patients with advanced heart failure. Both EntrestoTM and valsartan have previously been approved by the U.S. Food and Drug Administration (FDA)for people with heart failurea nd are available by prescription from a licensed medical doctor. Currently EntrestoTM is only available under the brand name EntrestoTM, there is no generic form of EntrestoTM. You do not have to take part in this study in order to receive EntrestoTM.

Study Details

Inclusion Criteria

  • Advanced HFrEF defined as including All:
    • LVEF ≥ 35% documented during the preceding 3 months.
    • Estimated GFR 20-60 mL/min/1.73m2.
    • NYHA class IV symptomatology for the majority of the previous month.
    • Minimum of 3 months GDMT for HF and/or intolerant to therapy
  • 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).
  • Systolic blood pressure ≥ 90 mmHg

Exclusion Criteria

  • Currently taking EntrestoTM.
  • History of hypersensitivity or intolerance to EntrestoTM, an ACEI or ARB as well as known or suspected contraindications to the study drugs.
  • Current or scheduled for LVAD implantation within 30 days of study enrollment.

Study Requirements

The study consists of 11 study visits over about 27 weeks. 7 in person study visits and 4 phone call visits. Some of these study visits may align with your regular clinical visits. At the first visit (the screening visit) the research team will determine whether or not you qualify for the LIFE study be performing a physical exam, a blood draw, and asking you to complete a few questionnaires. If you qualify you will be asked to come back for a randomization visit. At the randomization visit you will be randomly assigned (using a process like a coin flip) to decide your study group. You will have an equal chance (50%) of being enrolled in the EntrestoTM group or the Valsartan group. During the randomization visit and the following in person study visits you will be asked to complete some questionnaires about your heal, get a physical exam, get a blood draw and receive study drug. These visits take about an hour to an hour and a half. The phone call visits take about 5 - 10 minutes during which you will be asked about how you are feeling on the study drug and your overall health.