Efficacy and Safety of LCZ696 Compared to Valsartan on Cognitive Function in Patients With Chronic Heart Failure and Preserved Ejection Fraction



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:60 - Any
Updated:3/30/2019
Start Date:November 23, 2016
End Date:May 23, 2022
Contact:Novartis Pharmaceuticals
Phone:1-888-669-6682

Use our guide to learn which trials are right for you!

A Multicenter, Randomized, Double-blind, Active-controlled Study to Evaluate the Effects of LCZ696 Compared to Valsartan on Cognitive Function in Patients With Chronic Heart Failure and Preserved Ejection Fraction

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.


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:

1. Patients with serum potassium >5.2 mmol/L (mEq/L) at Screening visit

2. Patients with serum potassium >5.4 mmol/L (mEq/L) at any visit during run-in
treatment period or at randomization visit

3. Systolic blood pressure (SBP) ≥180 mmHg at Screening visit, or

4. SBP <110 mmHg at Screening visit, or

5. SBP <100 mmHg or symptomatic hypotension as determined by the investigator at
Visit 103 or at randomization visit

6. Body mass index (BMI) >45 kg/m^2

- Patients with

1. known pericardial constriction, genetic hypertrophic cardiomyopathy, infiltrative
cardiomyopathy

2. 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).
We found this trial at
78
sites
Gastonia, North Carolina 28054
?
mi
from
Gastonia, NC
Click here to add this to my saved trials
Andalusia, Alabama 36420
?
mi
from
Andalusia, AL
Click here to add this to my saved trials
Baltimore, Maryland 21287
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Beverly Hills, California 90211
?
mi
from
Beverly Hills, CA
Click here to add this to my saved trials
Birmingham, Alabama 35209
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Bronx, New York 10461
?
mi
from
Bronx, NY
Click here to add this to my saved trials
Buenos Aires, ARG
?
mi
from
Buenos Aires,
Click here to add this to my saved trials
Buffalo, New York 14215
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
Cincinnati, Ohio 45229
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Clearwater, Florida 33756
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
Dallas, Texas 75216
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Danbury, Connecticut 06810
?
mi
from
Danbury, CT
Click here to add this to my saved trials
Doral, Florida 33136
?
mi
from
Doral, FL
Click here to add this to my saved trials
Edgewater, Florida 32132
?
mi
from
Edgewater, FL
Click here to add this to my saved trials
Elmer, New Jersey 08318
?
mi
from
Elmer, NJ
Click here to add this to my saved trials
Eunice, Louisiana 70535
?
mi
from
Eunice, LA
Click here to add this to my saved trials
Everett, Washington 98208
?
mi
from
Everett, WA
Click here to add this to my saved trials
Fort Mill, South Carolina 29707
?
mi
from
Fort Mill, SC
Click here to add this to my saved trials
Fort Payne, Alabama 35967
?
mi
from
Fort Payne, AL
Click here to add this to my saved trials
Fresno, California 93710
?
mi
from
Fresno, CA
Click here to add this to my saved trials
Gilbert, Arizona 85234
?
mi
from
Gilbert, AZ
Click here to add this to my saved trials
Glendale, Arizona 85308
?
mi
from
Glendale, AZ
Click here to add this to my saved trials
Gonzales, Texas 78629
?
mi
from
Gonzales, TX
Click here to add this to my saved trials
Grand Forks, North Dakota 58201
?
mi
from
Grand Forks, ND
Click here to add this to my saved trials
Greensboro, North Carolina 27401
?
mi
from
Greensboro, NC
Click here to add this to my saved trials
Haddon Heights, New Jersey 08035
?
mi
from
Haddon Heights, NJ
Click here to add this to my saved trials
Hollywood, Florida 33021
?
mi
from
Hollywood, FL
Click here to add this to my saved trials
Homestead, Florida 34239
?
mi
from
Homestead, FL
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Inverness, Florida 34452
?
mi
from
Inverness, FL
Click here to add this to my saved trials
Jackson, Tennessee 38305
?
mi
from
Jackson, TN
Click here to add this to my saved trials
Jacksonville, Florida 32216
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Jacksonville Beach, Florida 32050
?
mi
from
Jacksonville Beach, FL
Click here to add this to my saved trials
Jupiter, Florida 33458
?
mi
from
Jupiter, FL
Click here to add this to my saved trials
Kalispell, Montana 59901
?
mi
from
Kalispell, MT
Click here to add this to my saved trials
Las Vegas, Nevada 89135
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Loma Linda, California 92354
?
mi
from
Loma Linda, CA
Click here to add this to my saved trials
Lombard, Illinois 60148
?
mi
from
Lombard, IL
Click here to add this to my saved trials
Long Beach, California 90813
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
Lufkin, Texas 75904
?
mi
from
Lufkin, TX
Click here to add this to my saved trials
Manhasset, New York 11030
?
mi
from
Manhasset, NY
Click here to add this to my saved trials
Mesa, Arizona 85205
?
mi
from
Mesa, AZ
Click here to add this to my saved trials
Miami, Florida 33136
?
mi
from
Miami, FL
Click here to add this to my saved trials
Milwaukee, Wisconsin 53209
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
Moncks Corner, South Carolina 29461
?
mi
from
Moncks Corner, SC
Click here to add this to my saved trials
Mount Pleasant, South Carolina 29464
?
mi
from
Mount Pleasant, SC
Click here to add this to my saved trials
Naples, Florida 34119
?
mi
from
Naples, FL
Click here to add this to my saved trials
Newport Beach, California 92663
?
mi
from
Newport Beach, CA
Click here to add this to my saved trials
Oregon City, Oregon 97045
?
mi
from
Oregon City, OR
Click here to add this to my saved trials
Pasadena, California 91105
?
mi
from
Pasadena, CA
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19102
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Phoenix, Arizona 85012
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Port Orange, Florida 32127
?
mi
from
Port Orange, FL
Click here to add this to my saved trials
Providence, Rhode Island 02908
?
mi
from
Providence, RI
Click here to add this to my saved trials
Reno, Nevada 89502
?
mi
from
Reno, NV
Click here to add this to my saved trials
Rock Hill, South Carolina 29732
?
mi
from
Rock Hill, SC
Click here to add this to my saved trials
Sacramento, California 95825
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
Saginaw, Michigan 48601
?
mi
from
Saginaw, MI
Click here to add this to my saved trials
Saint Louis, Missouri 63128
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Salt Lake City, Utah 84103
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
San Antonio, Texas 78207
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Santa Ana, California 92705
?
mi
from
Santa Ana, CA
Click here to add this to my saved trials
South Miami, Florida 33143
?
mi
from
South Miami, FL
Click here to add this to my saved trials
Southfield, Michigan 48075
?
mi
from
Southfield, MI
Click here to add this to my saved trials
Springfield, Illinois 62703
?
mi
from
Springfield, IL
Click here to add this to my saved trials
Springfield, Oregon 97477
?
mi
from
Springfield, OR
Click here to add this to my saved trials
Statesville, North Carolina 28625
?
mi
from
Statesville, NC
Click here to add this to my saved trials
Summerville, South Carolina 29485
?
mi
from
Summerville, SC
Click here to add this to my saved trials
Surprise, Arizona 85374
?
mi
from
Surprise, AZ
Click here to add this to my saved trials
Tacoma, Washington 98405
?
mi
from
Tacoma, WA
Click here to add this to my saved trials
Tampa, Florida 33613
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Topeka, Kansas 66606
?
mi
from
Topeka, KS
Click here to add this to my saved trials
Torrance, California 90502
?
mi
from
Torrance, CA
Click here to add this to my saved trials
Tucson, Arizona 85745
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Tyler, Texas 75701
?
mi
from
Tyler, TX
Click here to add this to my saved trials
Valhalla, New York 10595
?
mi
from
Valhalla, NY
Click here to add this to my saved trials
Webster, Texas 77598
?
mi
from
Webster, TX
Click here to add this to my saved trials
Winston-Salem, North Carolina 27157
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials