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

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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
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Danbury, Connecticut 06810
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Andalusia, Alabama 36420
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Fort Payne, Alabama 35967
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Fresno, California 93710
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