PERSPECTIVE

• Research type

  Research Study

• Full title

  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

• IRAS ID

  210424

• Contact name

  Andrew Clark

• Contact email

  A.L.Clark@hull.ac.uk

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2016-001254-17

• Duration of Study in the UK

  4 years, 6 months, 0 days

• Research summary

  Summary of Research

  Heart failure (HF) is a major public health problem associated with a high mortality rate, frequent hospitalizations, and poor quality of life. Despite existing treatment options, heart failure remains a progressive syndrome with a high mortality rate, and an illness with an unmet need for new therapies to improve health outcomes. Cognitive impairment has been reported in patients with heart failure in several studies over the past three decades. The prevalence of cognitive impairment observed in these heart failure studies (no distinction made between HFrEF or HFpEF) ranged from 25 to 75%. Changes in cognition as a result of improved cardiac function have not been extensively evaluated. However, studies in heart failure patients implanted with a left ventricular assist device showed that cognition, as assessed by a comprehensive battery of tests, was improved during follow-up ranging from 6 months to 2 years. The purpose of this study is to evaluate the effect of LCZ696 compared to valsartan on cognitive function in patients with HFpEF. Cognitive function will be assessed using the CogState comprehensive battery of tests, which include a longitudinal evaluation of key cognitive domains such as memory, executive function, and attention.
  In addition, the effect of LCZ696 therapy compared to valsartan on amyloid plaque deposition in the brain will be evaluated in a subset of patients using amyloid florbetapir 18F PET imaging.

  Summary of Results
  Plain trial language summary of results will be shared with the sites for distribution to the patients. Results will also be posted on clinicaltrials.gov, Eudract register and Novartis by 12 May 2023

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  16/EM/0382

• Date of REC Opinion

  30 Sep 2016

• REC opinion

  Further Information Favourable Opinion