PER-010-15招募中未知
A MULTICENTER, RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP, ACTIVE CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF LCZ696 COMPARED TO VALSARTAN, ON MORBIDITY AND MORTALITY IN HEART FAILURE PATIENTS (NYHA CLASS II-IV) WITH PRESERVED EJECTION FRACTIO
OVARTIS BIOSCIENSES PERU S.A.,0 个研究点目标入组 32 人开始时间: 2015年6月9日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 55 至 100（—）
- 性别
- All
入选标准
- •Written informed consent must be obtained before any assessment is
- •≥55 years of age, male or female
- •LVEF ≥45% by echocardiogram (echo) during the screening epoch, or
- •within 6 months prior to Visit 1(any local LVEF measurement made
- •using echo only)
- •Symptom(s) of HF requiring treatment with diuretic(s) for HF ≥30 daysprior to Visit 1
- •Current symptom(s) of HF (NYHA Class II-IV) at Visit 1
- •Structural heart disease evidenced by one or both of the following
- •echo findings (any local measurement made during the screening
- •epoch or within the 6 months prior to Visit 1):
- •left atrial (LA) enlargement defined by at least one of the following: LA
- •width ≥3.8 cm or LA length ≥5.0 cm or LA area ≥20 cm2 or LA volume
- •≥55 mL or LA volume index ≥29 mL/m2
- •left ventricular hypertrophy (LVH) defined by septal thickness or
- •posterior wall thickness ≥1.1 cm
- •Patients with at least one of the following:
- •a HF hospitalization (defined as HF as the major reason for
- •hospitalization or treatment for HF lasting ≥12 hours and including
- •intravenous [IV] diuretics at a healthcare facility) within 9 months prior
- •to Visit 1,
- •Visit 1 elevated NT-proBNP (>300 pg/ml for patients not in atrial
- •fibrillation (AF) or >900 pg/ml for patients in AF on the Visit 1 ECG).
排除标准
- •Any prior measurement of LVEF < 45%.
- •Acute coronary syndrome (including MI), cardiac surgery, other major
- •CV surgery, or urgent percutaneous coronary intervention (PCI) within
- •the 3 months prior to Visit 1 or an elective PCI within 30 days prior to
- •Patients who have had an MI, coronary artery bypass graft (CABG) or
- •other event within the 6 months prior to Visit 1 that could have reduced
- •their EF unless an echo measurement performed after the event
- •confirms a LVEF ≥45%.
- •Current acute decompensated HF requiring augmented therapy with
- •diuretics, vasodilators and/or inotropic drugs.
- •Patients who require treatment with 2 or more of the following: an
- •angiotensin converting enzyme inhibitor (ACEI), an angiotensin
- •receptor blocker (ARB) or a renin inhibitor.
- •History of hypersensitivity to any of the study drugs or to drugs of
- •similar chemical classes.
- •Patients with a known history of angioedema.
- •Probable alternative diagnoses that in the opinion of the investigator
- •could account for patient’s HF symptoms (i.e., dyspnea, fatigue) such
- •as significant pulmonary disease (including primary pulmonary
- •hypertension), anemia or obesity. Specifically, patients with the below
- •are excluded:
- •severe chronic obstructive pulmonary disease (COPD) (i.e., requiring
- •home oxygen, chronic nebulizer therapy, chronic oral steroid therapy
- •or hospitalized for pulmonary decompensation within 12 months) or
- •hemoglobin (Hgb) <10 g/dl, or
- •body mass index (BMI) > 40 kg/m2
- •Patients with any of the following:
- •systolic blood pressure (SBP) ≥ 180 mmHg at Visit 1, or
- •SBP >150 mmHg and <180 mmHg at Visit 1 unless the patient
研究者
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