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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02884206
Registration number
NCT02884206
Ethics application status
Date submitted
25/08/2016
Date registered
30/08/2016
Date last updated
3/11/2022
Titles & IDs
Public title
Efficacy and Safety of LCZ696 Compared to Valsartan on Cognitive Function in Patients With Chronic Heart Failure and Preserved Ejection Fraction
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Scientific 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
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Secondary ID [1]
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2016-001254-17
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Secondary ID [2]
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CLCZ696B2320
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Universal Trial Number (UTN)
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Trial acronym
PERSPECTIVE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Heart Failure (CHF)
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - LCZ696
Treatment: Drugs - Valsartan
Treatment: Drugs - Placebo of LCZ696
Treatment: Drugs - Placebo of Valsartan
Experimental: LCZ696 - 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.
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.
Treatment: Drugs: LCZ696
LCZ696 50, 100, and 200 mg tablets taken orally twice daily with matching placebo for valsartan
Treatment: Drugs: Valsartan
Valsartan 40, 80, and 160 mg tablets taken orally twice daily with matching placebo for LCZ696
Treatment: Drugs: Placebo of LCZ696
Placebo to match LCZ696 50 mg, 100 mg, and 200 mg tablets
Treatment: Drugs: Placebo of Valsartan
Placebo to match valsartan 40 mg, 80 mg, and 160 mg tablets
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change from baseline in the CogState Global Cognitive Composite Score (GCCS)
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline, week 156
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Secondary outcome [1]
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Change from baseline in cortical composite standardized uptake value ratio (SUVr)
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline, week 156
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Secondary outcome [2]
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Change from baseline in individual cognitive domains (memory, executive function, and attention)
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Assessment method [2]
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Specific cognitive domains to be assessed include memory, executive function, and attention. A negative change from baseline will indicate worsening performance.
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Timepoint [2]
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Baseline, week 156
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Secondary outcome [3]
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Change from baseline in the summary score of the instrumental activities of daily living (IADL)
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline, week 156
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Eligibility
Key inclusion criteria
Key
- 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
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Minimum age
60
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
23/11/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
16/05/2022
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Sample size
Target
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Accrual to date
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Final
592
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Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
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Recruitment hospital [1]
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Novartis Investigative Site - Chemside
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Novartis Investigative Site - Milton
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Novartis Investigative Site - Bedford Park
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Novartis Investigative Site - Geelong
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4032 - Chemside
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4064 - Milton
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5042 - Bedford Park
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3220 - Geelong
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Funding & Sponsors
Primary sponsor type
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Name
Novartis Pharmaceuticals
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Address
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Ethics approval
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02884206
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Novartis Pharmaceuticals
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Novartis Pharmaceuticals
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02884206
Download to PDF