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

ovartis Pharma Services AG0 个研究点目标入组 4,600 人开始时间: 2013年9月27日最近更新: 2019年11月25日

试验速览

暂无简介。

•- 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

•- 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 entry.
•- 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 =45%.
•- 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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