PERSPECTIVE: Prospective Evaluation of cognitive function in heart failure: A Randomized double-blind Study in Patients with preserved Ejection fraction Cardiac failure Treated wIth Valsartan or EntrestoStudio multicentrico, randomizzato, in doppio cieco, con controllo attivo per valutare gli effetti di LCZ696 rispetto a valsartan sulla funzione cognitiva in pazienti con scompenso cardiaco cronico a frazione di eiezione preservata - PERSPECTIVE

OVARTIS PHARMA SERVICES AG0 sites592 target enrollmentNovember 4, 2020

Overview

No summary available.

Registry

who.int

Start Date

November 4, 2020

End Date

May 16, 2022

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Written informed consent including consent for APOE4 gene testing must be obtained before any assessment is performed
•2\. Male or female patients aged \= 60 years of age.
•3\. Chronic heart failure with current symptom(s) (NYHA class II\-IV) at Screening visit.
•4\. LVEF \> 40%
•a. By any method using most recent assessment within 6 months prior to screening visit OR
•b. By an echocardiogram performed during the screening visit, if previous assessment is not available.
•5\. NT\-proBNP \= 125 pg/mL at Screening visit
•6\. Patient with evidence of adequate functioning (e.g.: intellectual, motor, visual and auditory) to complete the study assessments and has elementary education or 6 years of sustained employment.
•Are the trial subjects under 18? no
•Number of subjects for this age range:

•1\. Current acute decompensated HF requiring augmented therapy with diuretics, vasodilators and/or inotropic drugs.
•2\. Acute coronary syndrome (including myocardial infarction (MI)), cardiac surgery, other major cardiovascular (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.
•3\. Patients with history of hereditary or idiopathic angioedema or angioedema related to previous angiotensin converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) therapies.
•4\. Patients who require treatment with 2 or more of the following: an ACEi, an ARB or a renin inhibitor.
•5\. Patients with one of the following:
•a. Estimated glomerular filtration rate (eGFR) \<30 mL/min/1\.73 m2 as calculated by the Modification of Diet in Renal Disease (MDRD) formula at screening visit, or
•b. eGFR \<25 mL/min/1\.73m2 at Visit 103 or at end of run\-in / randomization visit, or
•c. eGFR reduction \>35% (compared to Visit 1\) at Visit 103 or Visit 199/201
•6\. MMSE score \<24 at Screening visit