Heart Failure Clinical Trial
Efficacy and Safety of LCZ696 Compared to Valsartan on Cognitive Function in Patients With Chronic Heart Failure and Preserved Ejection Fraction
Summary
The purpose of this study is to evaluate the effect of LCZ696 compared to valsartan on cognitive function in patients with chronic heart failure and preserved ejection fraction. Cognitive function will be assessed using a comprehensive battery of tests with an evaluation of longitudinal change of cognitive domains including memory, executive function, and attention.
Eligibility Criteria
Key Inclusion Criteria:
Chronic heart failure with current symptoms NYHA class II-IV
Left ventricular ejection fraction > 40%
NT-proBNP >= 125 pg/mL at screening visit
Patient with evidence of adequate functioning to complete study assessments
Key Exclusion Criteria:
Patients with acute decompensated heart failure requiring augmented therapy with diuretics, vasodilators and/or inotropic drugs
Acute coronary syndrome (including myocardial infarction (MI)), cardiac surgery, other major CV surgery, or urgent percutaneous coronary intervention (PCI), carotid surgery or carotid angioplasty, history of stroke or transient ischemic attack within the 3 months prior to Screening visit or an elective PCI within 30 days prior to Screening visit
Patients with history of hereditary or idiopathic angioedema or angioedema related to previous ACEi or ARB therapies
Patients who require treatment with 2 or more of the following: an ACEi, an ARB or a renin inhibitor
Patients with one of the following:
Patients with serum potassium >5.2 mmol/L (mEq/L) at Screening visit
Patients with serum potassium >5.4 mmol/L (mEq/L) at any visit during run-in treatment period or at randomization visit
Systolic blood pressure (SBP) ≥180 mmHg at Screening visit, or
SBP <110 mmHg at Screening visit, or
SBP <100 mmHg or symptomatic hypotension as determined by the investigator at Visit 103 or at randomization visit
Body mass index (BMI) >45 kg/m^2
Patients with
known pericardial constriction, genetic hypertrophic cardiomyopathy, infiltrative cardiomyopathy
hemodynamically significant obstructive valvular disease
Life-threatening or uncontrolled dysrhythmia, including symptomatic or sustained ventricular tachycardia and atrial fibrillation or flutter with a resting ventricular rate >110 beats per minute
Inability to perform cognitive battery or other study evaluations based on significant motor (e.g. hemiplegia, muscular-skeletal injury) or sensory (blindness, decreased or uncorrected visual or auditory acuity) skill
Clinically significant cerebral pathology for example large cerebral aneurysm or space occupying lesion that may impact cognition as assessed by central MRI reader
Mini mental state examination score less than 24 at screening
Patients with a clinical diagnosis of Alzheimer's disease or other dementia syndromes or any indication for or current treatment with cholinesterase inhibitors and/or another prescription AD treatment (e.g. memantine).
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There are 134 Locations for this study
Andalusia Alabama, 36420, United States
Glendale Arizona, 85306, United States
Mesa Arizona, 85206, United States
Phoenix Arizona, 85004, United States
Sun City West Arizona, 85375, United States
Tucson Arizona, 85723, United States
Beverly Hills California, 90211, United States
Fresno California, 93720, United States
Loma Linda California, 92357, United States
Long Beach California, 90806, United States
Newport Beach California, 92663, United States
Santa Ana California, 92704, United States
Santa Ana California, 92705, United States
Torrance California, 90503, United States
Danbury Connecticut, 06810, United States
Clearwater Florida, 33756, United States
Edgewater Florida, 32132, United States
Hollywood Florida, 33312, United States
Homestead Florida, 33030, United States
Inverness Florida, 34452, United States
Jacksonville Beach Florida, 32050, United States
Miami Florida, 33133, United States
Miami Florida, 33144, United States
Miami Florida, 33176, United States
Naples Florida, 34102, United States
Port Orange Florida, 32127, United States
Tampa Florida, 33612, United States
Lombard Illinois, 60148, United States
Springfield Illinois, 62701, United States
Topeka Kansas, 66606, United States
Eunice Louisiana, 70535, United States
Baltimore Maryland, 21229, United States
Saginaw Michigan, 48601, United States
Saint Louis Missouri, 63110, United States
Kalispell Montana, 59901, United States
Reno Nevada, 89502, United States
Elmer New Jersey, 08318, United States
Buffalo New York, 14215, United States
Gastonia North Carolina, 28054, United States
Cincinnati Ohio, 45219, United States
Oregon City Oregon, 97045, United States
Springfield Oregon, 97477, United States
Fort Mill South Carolina, 29707, United States
Rock Hill South Carolina, 29732, United States
Summerville South Carolina, 29485, United States
Dallas Texas, 75226, United States
Dallas Texas, 75235, United States
Gonzales Texas, 78629, United States
Houston Texas, 77030, United States
Lufkin Texas, 75904, United States
San Antonio Texas, 78229, United States
Tacoma Washington, 98405, United States
Buenos Aires ARG, C1405, Argentina
Caba Buenos Aires, 1407, Argentina
Ciudad Autonoma de Bs As Buenos Aires, C1119, Argentina
Ramos Mejia Buenos Aires, B1704, Argentina
Caba Capital Federal, C1179, Argentina
Chemside Queensland, 4032, Australia
Milton Queensland, 4064, Australia
Bedford Park South Australia, 5042, Australia
Geelong Victoria, 3220, Australia
Aalst , 9300, Belgium
Sofia BGR, 1407, Bulgaria
Sofia , 1431, Bulgaria
Hamilton Ontario, L8L 2, Canada
Greenfield Park Quebec, J4V 2, Canada
Rijeka , 51000, Croatia
Zagreb , 10000, Croatia
Paris , 75013, France
Tourcoing , 59208, France
Regensburg Bavaria, 93053, Germany
Dresden Sachsen, 01099, Germany
Berlin Buch , 13125, Germany
Berlin , 10367, Germany
Berlin , 13353, Germany
Bielefeld , 33604, Germany
Bitburg , 54634, Germany
Dessau-Roßlau , 06846, Germany
Dresden , 01277, Germany
Elsterwerda , 04910, Germany
Frankfurt , 60594, Germany
Koeln , 50937, Germany
Koeln , 51065, Germany
Ulm , 89077, Germany
Wuerzburg , 97080, Germany
Wuppertal , 42109, Germany
Ancona AN, 60128, Italy
Bergamo BG, 24127, Italy
Cona FE, 44100, Italy
Firenze FI, 50134, Italy
Pozzilli IS, 86077, Italy
Rozzano MI, 20089, Italy
Modena MO, 41100, Italy
Pisa PI, 56124, Italy
Wonju Gangwon-Do, 26426, Korea, Republic of
Seongnam Si Gyeonggi Do, 13620, Korea, Republic of
Seoul Korea, 03080, Korea, Republic of
Kaunas LTU, LT 50, Lithuania
Vilnius , LT-08, Lithuania
Amsterdam , 1081 , Netherlands
Hertogenbosch , 5200, Netherlands
Lodz Lodzkie, 90 54, Poland
Tarnow Malopolskie, 33-10, Poland
Krakow Maloposkie, 31271, Poland
Bialystok , 15 27, Poland
Katowice , 40-64, Poland
Krakow , 31 20, Poland
Warszawa , 02-09, Poland
Moscow , 12764, Russian Federation
Saint Petersburg , 19702, Russian Federation
Saint Petersburg , 19910, Russian Federation
Saratov , 41001, Russian Federation
St Petersburg , 19660, Russian Federation
Valencia Comunidad Valenciana, 46010, Spain
San Sebastian de los Reyes Madrid, 28702, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Valencia , 46026, Spain
Zaragoza , 50009, Spain
Basel , 4031, Switzerland
Tainan , 70403, Taiwan
Taipei , 10002, Taiwan
Taipei , 11217, Taiwan
Meselik Eskisehir, 26480, Turkey
Sivas , 58140, Turkey
Axbridge Somerset, BS26 , United Kingdom
Cardiff Wales, CF5 4, United Kingdom
Birmingham , B16 8, United Kingdom
Bournemouth , BH7 7, United Kingdom
East Yorkshire , HU16 , United Kingdom
Harrow , HA1 3, United Kingdom
Liverpool , L9 7A, United Kingdom
Newport , NP20 , United Kingdom
Stevenage , SG1 4, United Kingdom
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