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

• Status: Active, not recruiting
• Trial end date: 2022-03-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: LCZ 696; Sacubitril and valsartan sodium hydrate drug combination; Valsartan

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:

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).