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PERSPECTIVE

Objective

Status Enrolling

Condition Congestive Heart Failure with preserved ejection fraction

Description

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

Purpose

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. 

Phase III

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

    only).

3. Patients with at least one of the following:

a. Patient with prior Heart Failure hospitalization in 12 months prior to  

    Screening Visit.

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

  1. 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
  2. Patients with history of angioedema.
  3. Diagnosis of Alzheimer’s disease or other dementia syndromes.

ClinicalTrials.gov Identifier

NCT02884206

Protocol Number

CLCZ696B2320

Principal Investigator(s)
Rabeea Aboufakher, MD

Clinical Trial Categories

  • Cardiology
Sponsor(s)
Novartis
Contact
Dianne Vold, LPN CCRC at 701-780-1559
or dvold@altru.org