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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02884206




Registration number
NCT02884206
Ethics application status
Date submitted
25/08/2016
Date registered
30/08/2016

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
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
Secondary ID [1] 0 0
2016-001254-17
Secondary ID [2] 0 0
CLCZ696B2320
Universal Trial Number (UTN)
Trial acronym
PERSPECTIVE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Heart Failure (CHF) 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LCZ696
Treatment: Drugs - Valsartan
Treatment: Drugs - Placebo of LCZ696
Treatment: Drugs - Placebo of Valsartan

Experimental: LCZ696 200 mg bid - Patients who were able to tolerate the treatment during the single-blind treatment run-in epoch. Following the run-in period, patients randomized in this arm were given LCZ696 at 200 mg twice daily for three years

Active comparator: Valsartan 160 mg bid - Patients who were able to tolerate the treatment during the single-blind treatment run-in epoch. Following the run-in period, patients randomized in this arm were 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in the CogState Global Cognitive Composite Score (GCCS)
Timepoint [1] 0 0
Baseline, month 36
Secondary outcome [1] 0 0
Change From Baseline in Cortical Composite Standardized Uptake Value Ratio (SUVr)
Timepoint [1] 0 0
Baseline, month 36
Secondary outcome [2] 0 0
Change From Baseline in Individual Cognitive Domains
Timepoint [2] 0 0
Baseline, month 36
Secondary outcome [3] 0 0
Change From Baseline in the Summary Score of the Instrumental Activities of Daily Living (IADL)
Timepoint [3] 0 0
Baseline, month 36

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

Key
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/11/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/05/2022
Sample size
Target
Accrual to date
Final
592
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Chemside
Recruitment hospital [2] 0 0
Novartis Investigative Site - Milton
Recruitment hospital [3] 0 0
Novartis Investigative Site - Bedford Park
Recruitment hospital [4] 0 0
Novartis Investigative Site - Geelong
Recruitment postcode(s) [1] 0 0
4032 - Chemside
Recruitment postcode(s) [2] 0 0
4064 - Milton
Recruitment postcode(s) [3] 0 0
5042 - Bedford Park
Recruitment postcode(s) [4] 0 0
3220 - Geelong
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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California
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Connecticut
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Louisiana
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Michigan
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Missouri
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Aalst
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BGR
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Rijeka
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Spain
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Comunidad Valenciana
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Spain
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Madrid
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Valencia
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Spain
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Switzerland
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Taipei
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Turkey
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Eskisehir
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Sivas
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Somerset
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Wales
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Birmingham
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Bournemouth
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East Yorkshire
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Harrow
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Liverpool
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Newport
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United Kingdom
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Stevenage

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02884206