Condition Congestive Heart Failure with preserved ejection fraction
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 with preserved ejection fraction
To evaluate the effect of LCZ696 compared to valsartan in the reduction of CV death and rate of HF hospitalizations in patients with HFpEF. This study will serve as a registration trial for LCZ696 as a treatment for patients with HFpEF and if it has an effect on various mental abilities, such as thinking and memory.
Key Inclusion Criteria
1. Age ≥60 years of age.
2. LVEF >40% by ECHO during the Screening epoch, or within 6 months
prior to Screening visit (any local LVEF measurement made using echo
3. Patients with at least one of the following:
a. Patient with prior Heart Failure hospitalization in 12 months prior to
b. NT-proBNP > 200 pg/mL at Screening Visit
4. Patient with evidence of adequate functioning (e.g.: intellectual, motor, visual and auditory) to complete the study assessments and has at least 6 years of regular schooling or sustained employment.
Key Exclusion Criteria
- Acute Coronary Syndrome (including Myocardial Infarction (MI)), cardiac surgery, other major CV urgery, or urgent percutaneous coronary intervention (PCI), carotid surgery or carotid angioplasty, history of stroke or transient ischemic
- Patients with history of angioedema.
- Diagnosis of Alzheimer’s disease or other dementia syndromes.