365
Participants
Start Date
March 2, 2017
Primary Completion Date
September 15, 2020
Study Completion Date
September 29, 2020
LCZ696
"Subjects previously taking no or low-dose ACEI or ARB, or who have an eGFR \< 30 mL/min/1.73m²: starting dose of LCZ696 = 50 mg po BID.~Subjects taking an ARB at greater than low dose: starting dose of LCZ696 = 100 mg po BID.~Subjects taking an ACEI at greater than low dose: starting dose of LCZ696 = 100 mg po BID.~\* At Investigator discretion, study drug may be started at the low dose if there are any concerns regarding tolerability.~Dose adjustments will be performed every 2 weeks by doubling the dose of LCZ696 up to the target max dose of 200 mg po BID as tolerated.~The doses of LCZ696 are 50mg (one low-dose (50mg) tablet), 100mg (one high-dose (100mg) tablet), and 200mg (two high-dose (100mg) tablets.) These doses are equivalent to 24/26 mg, 49/51 mg, and 97/103 mg commercial Entresto™, respectively."
valsartan
"Subjects previously taking no or low-dose ACEI or ARB, or who have an eGFR \< 30 mL/min/1.73m²: the starting dose of valsartan = 40 mg po BID.~Subjects taking an ARB at greater than low dose: starting dose of valsartan = 80 mg po BID.~Subjects taking an ACEI at greater than low dose: starting dose of valsartan = 80 mg po BID.~\* At Investigator discretion, study drug may be started at the low dose if there are any concerns regarding tolerability.~Dose adjustments will be performed every 2 weeks by doubling the dose of valsartan up to the target maximum dose of 160 mg po BID, as tolerated.~The doses of valsartan are 40mg (one low-dose (40mg) tablet), 80mg (one high-dose (80mg) tablet), and 160mg (two high-dose (80mg) tablets)."
LCZ696 placebo
LCZ696 placebo tablets will be supplied to match the low-dose (50mg) and high-dose (100mg) active LCZ696 tablets. Dosing for LCZ696 placebo will mirror dosing for active valsartan (the same number of low or high-dose tablets will be given.)
valsartan placebo
Valsartan placebo tablets will be supplied to match the low-dose (40mg) and high-dose (80mg) active valsartan tablets. Dosing for valsartan placebo will mirror dosing for active LCZ696 (the same number of low or high-dose tablets will be given.)
Mount Sinai Hospital, New York
Stony Brook University Medical Center, Stony Brook
Allegheny General Hospital, Pittsburgh
Geisinger Medical Center, Wilkes-Barre
University of Pennsylvania, Philadelphia
Thomas Jefferson University Hospital, Philadelphia
MedStar Washington Hospital Center, Washington D.C.
Johns Hopkins Hospital, Baltimore
Inova Heart and Vascular Insititute, Falls Church
Sentara Norfolk General Hospital, Norfolk
Duke University Medical Center, Durham
Charlotte-Mecklenburg Hospital Authority, Charlotte
Piedmont Heart Institute, Atlanta
Emory University School of Medicine, Atlanta
Vanderbilt University Medical Center, Nashville
The Ohio State University Medical Center, Columbus
Case Western Medical Center, Cleveland
Metro Health System, Cleveland
Cleveland Clinic, Cleveland
The Christ Hospital, Cincinnati
St. Vincent Medical Group, Indianapolis
University of Michigan Health System, Ann Arbor
Mayo Clinic, Rochester
Advocate Christ Medical Center, Oak Lawn
Washington University, St Louis
Saint Louis University Hospital, St Louis
Ochsner Clinic Foundation, New Orleans
Integris Baptist Medical Center, Oklahoma City
Houston Methodist Research Institute, Houston
University of Utah School of Medicine, Salt Lake City
Cedars-Sinai Heart Institute, Beverly Hills
San Diego Cardiac Center, San Diego
Sutter Health Mills-Peninsula Health Services, Sacramento
Oregon Health and Science University, Portland
University of Washington Medical Center, Seattle
Tufts Medical Center, Boston
Massachusetts General Hospital, Boston
Brigham and Women's Hospital, Boston
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Duke University
OTHER