EUCTR2013-001747-31-PL进行中（未招募）1 期
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 fraction. - PARAGON-HF
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
- 4,600
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
入选标准
- •- Left ventricular ejection fraction (LVEF) =45% prior to study entry.
- •- Symptom(s) of heart failure (HF) and requiring treatment with diuretic(s) for HF =30 days prior to study entry.
- •- Current symptom(s) of HF.
- •- Structural heart disease (left atrial enlargement or left ventricular hypertrophy) documented by
- •echocardiogram.
- •- At least one of the following: a HF hospitalization within 9 months prior to study entry and/or an elevated NT-proBNP.
- •- Other protocol-defined inclusion criteria may apply.
- •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 990
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3310
排除标准
- •- Any prior echocardiographic measurement of LVEF < 40%.
- •- Acute coronary syndrome (including myocardial infarction (MI)),
- •cardiac surgery, other major cardiovascular surgery within 3 months, or
- •urgent percutaneous coronary intervention (PCI) within 30 days of
- •- Any clinical event within 6 months that could have reduced the LVEF
- •(e.g., MI, coronary artery bypass graft [CABG]), unless an echo
- •measurement was performed after the event confirming the LVEF to be =
- •- Current acute decompensated HF requiring therapy.
- •- 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.
- •- Alternative reason for shortness of breath such as: significant
- •pulmonary disease or severe COPD, hemoglobin (Hgb) <10 g/dl, or body
- •mass index (BMI) > 40 kg/m2.
- •- Systolic blood pressure (SBP) = 180 mmHg at entry, or SBP >150
- •mmHg and <180 mmHg at entry unless the patient is receiving 3 or more
- •antihypertensive drugs.
- •- Other protocol-defined exclusion criteria may apply.
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