Efficacy and Safety of LCZ696 Compared to Valsartan on Cognitive Function in Patients With Chronic Heart Failure and Preserved Ejection Fraction (PERSPECTIVE)
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|ClinicalTrials.gov Identifier: NCT02884206|
Recruitment Status : Recruiting
First Posted : August 30, 2016
Last Update Posted : June 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Heart Failure (CHF)||Drug: LCZ696 Drug: Valsartan Drug: Placebo of LCZ696 Drug: Placebo of Valsartan||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||520 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official 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|
|Actual Study Start Date :||November 23, 2016|
|Estimated Primary Completion Date :||July 14, 2021|
|Estimated Study Completion Date :||May 23, 2022|
Patients will receive LCZ696 at 100 mg twice daily during a single-blind treatment run-in period to ensure patients tolerate this medication before they are randomized. Down-titration is not allowed during this period. Patients who are able to tolerate LCZ696 100 mg twice daily are eligible to enter the randomized treatment period. Patients randomized to receive LCZ696 will be given LCZ696 at 200 mg twice daily. Patients will receive randomized study drug for three years.
LCZ696 50, 100, and 200 mg tablets taken orally twice daily with matching placebo for valsartan
Drug: Placebo of Valsartan
Placebo to match valsartan 40 mg, 80 mg, and 160 mg tablets
Active Comparator: Valsartan
Patients will receive valsartan at 40mg and/or 80mg twice daily during a single-blind treatment run-in period. Following the run-in period, patients randomized to receive valsartan will be given valsartan at 160 mg twice daily for three years.
Valsartan 40, 80, and 160 mg tablets taken orally twice daily with matching placebo for LCZ696
Drug: Placebo of LCZ696
Placebo to match LCZ696 50 mg, 100 mg, and 200 mg tablets
- Change from baseline in the CogState Global Cognitive Composite Score (GCCS) [ Time Frame: baseline, week 156 ]Change in cognition is assessed as a change in a Global Cognitive Composite Z score. The cognitive composite comprises cognitive domains including attention, memory, and executive function. A negative change from baseline will indicate worsening performance.
- Change from baseline in cortical composite standardized uptake value ratio (SUVr) [ Time Frame: Baseline, week 156 ]Changes in amyloid plaque deposition over time will be assessed using florbetapir-18F. The longitudinal change in the standardized uptake value ratio will be determined.
- Change from baseline in individual cognitive domains (memory, executive function, and attention) [ Time Frame: Baseline, week 156 ]Specific cognitive domains to be assessed include memory, executive function, and attention. A negative change from baseline will indicate worsening performance.
- Change from baseline in the summary score of the instrumental activities of daily living (IADL) [ Time Frame: Baseline, week 156 ]Instrumental activities of daily living will be assessed using the functional activities questionnaire. The functional activities questionnaire will be used as a standardized assessment of activities of daily living. This questionnaire is typically used to distinguish normal subjects from subjects with mild to moderate cognitive impairment. The test is made up of 10 questions that reflect a subject's ability to perform activities of daily living and to function independently. Test scores range from 0 to 30, a score of 0 is completely normal where as a higher score denotes impairment. Each of 10 questions is scored from 0, representing normal to 3, dependent on someone else to perform the activity. A negative change from baseline denotes improvement.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02884206
|Contact: Novartis Pharmaceuticals||1-888-669-6682|
|Contact: Novartis Pharmaceuticals||+41613241111|
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|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|