EUCTR2016-003410-28-AT进行中（未招募）1 期
A 24-week, randomized, double-blind, multi-center, parallel group, active controlled study to evaluate the effect of LCZ696 on NT-proBNP, exercise capacity, symptoms, and safety compared to individualized medical management of comorbidities in patients with heart failure and preserved ejection fraction
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
- 2,500
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
- •- Left ventricular ejection fraction (LVEF) =40% by echo within 6 months prior to study entry or during the screening epoch
- •- Symptom(s) of heart failure (HF) requiring treatment with diuretics (including loop, or thiazide diuretics, or mineralocorticoid antagonist [MRAs]) for at least 30 days prior to study entry
- •- NYHA class II-IV
- •- Structural heart disease (left atrial enlargement or left ventricular hypertrophy) documented by echocardiogram.
- •- NT-proBNP > 220 pg/mL for patients with no atrial fibrillation/atrial flutter (AF) or >600 pg/mL for patients with AF
- •- KCCQ clinical summary score < 75
- •- Patients on ACEi or ARB therapy must have a history of HTN
- •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 403
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2097
排除标准
- •- Any prior measurement of LVEF = 40% under stable conditions
- •- Acute coronary syndrome (including MI), cardiac surgery, other major CV surgery within 3 months , or urgent percutaneous coronary intervention (PCI) within 3 months or an elective PCI within 30 days prior to study entry
- •- Any clinical event within the 6 months prior to Visit 1 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 > 40%
- •- Current (within 30 days from visit 1) acute decompensated HF requiring therapy.
- •- Current (within 30 days from visit 1) use of renin inhibitor(s) dual RAS blockade or LCZ696
- •- History of hypersensitivity to LCZ696 or its components
- •- Patients with a known history of angioedema
- •- Walking distance primarily limited by non-cardiac comorbid conditions at visit 1
- •- Alternative reason for shortness of breath such as: significant pulmonary disease or severe COPD, hemoglobin (Hgb) <10 g/dL males and < 9.5 g/dL
- •females, or body mass index (BMI) > 40 kg/m2.
- •- Systolic blood pressure (SBP) = 180 mmHg at study entry, or SBP >150 mmHg and <180 mmHg at study entry unless the patient is receiving 3 or more
- •antihypertensive drugs, or SBP < 110 mmHg at study entry.
- •- Patients with HbA1c > 7.5% not treated for diabetes
- •- Patients with prior major organ transplant or intent to transplant (ie on transplant list)
- •- eGFR < 30 ml/min/1.73 m2 as measured by MDRD at screening
- •- Serum potassium > 5.2 mmol /L (or equivalent plasma potassium value)
- •- History or presence of any other disease with a life expectancy of < 3 years
- •- Pregnant or nursing women or women of childbearing potential unless they are using highly effective methods of contraception.
- •Other protocol-defined exclusion criteria may apply.
研究者
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