EUCTR2016-001254-17-IT进行中（未招募）1 期
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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 592
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 75
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 445
排除标准
- •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
- •7. 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 Alzheimer's Disease (AD) treatment (e.g., memantine).
- •8. Any history of medical or neurological condition likely to affect the participant's cognition (e.g., clinically significant brain trauma with loss of consciousness > 3 minutes within 6 months prior to screening, Huntington's disease, Parkinson's disease, Lyme's disease, syphilis, HIV dementia, uncontrolled seizure disorder) or clinically significant abnormalities in thyroid function tests, Vitamin B12 or folate deficiency requiring treatment at screening. (Patients who are adequately treated may be included at investigator discretion).
- •9. 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.
- •10. Score yes on item 4 or item 5 of the Suicidal Ideation section of the Columbia suicidality severity rating scale (C-SSRS), if this ideation occurred in the past 6 months, or yes on any item of the Suicidal Behavior section, except for the Non-Suicidal Self-Injurious Behavior (item also included in the Suicidal Behavior section), if this behavior occurred in the past 2 years.
- •11. Clinically significant cerebral pathology, for example large cerebral aneurysm, space occupying lesion etc. that may impact cognition as assessed by MRI central reader.
- •12. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
- •13. History or presence of any other disease with a life expectancy of <3 years
- •14. Women of child bearing potential defined as all women physiologically capable of becoming pregnant.
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