NL-OMON49300已完成2 期
A randomized, double blind, placebo-controlled, parallel group, multicentre, phase 2a study to assess target engagement, safety and tolerability of AZD4831 in patients with Heart Failure with preserved Ejection Fraction (HFpEF). - SATELLITE
Astra Zeneca0 个研究点目标入组 16 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
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
- 18 至 99（—）
入选标准
- •Informed consent 1. Capable of giving signed informed consent which includes
- •compliance with the requirements and restrictions listed in the informed
- •consent form (ICF) and in this CSP 2. Provision of signed and dated, written
- •informed consent form prior to any mandatory study specific procedures,
- •sampling, and analyses, Age 3. Patient must be 45 to 85 years of age inclusive,
- •at the time of signing the informed consent form, Type of patient and disease
- •characteristics 4. Signs and symptoms of HF in judgement of Investigator AND a.
- •Stable NYHA II-IV and b. Ejection fraction (EF) \u2265 40 % and c. Elevated
- •NT-proBNP or BNP in the last 1 year defined as: * Measured as out-patient:
- •NT-proBNP \u2265125 ng/L or BNP\u226535 ng/L with sinus rhythm, NT-proBNP
- •\u2265750 ng/L or BNP \u2265200 ng/L with atrial fibrillation (AF), OR *
- •Measured when hospitalized acutely: NT-proBNP \u2265500 (ng/L) or BNP \u2265125
- •ng/L with sinus rhythm, NT-proBNP \u22651250 (ng/L) or BNP \u2265350 ng/L with
- •AF d. And at least one of the following: \u2022 Hospitalization with HF as
- •primary cause in last 12 months \u2022 Structural heart disease on echo
- •according to ESC guidelines i.e. either enlarged Left atrial volume index (LAVI
- •>34 ml/m2) or increased LVM (LVM index >95 g/m2 in women and >115 g/m2 in men)
- •\u2022 Pulmonary capillary wedge pressure (PCWP) at rest >15 mmHg or >25 mmHg
- •at exercise \u2022 Spectral tissue Doppler echocardiography - E/e\u2019 ratio
- •\u226513 at rest, Weight 5. Body Mass Index (BMI) range 18-40 kg/m2, Sex 6.
- •Male or female of nonchildbearing potential, Reproduction 7. Female patients
- •must be 1 year post-menopausal or surgically sterile 8. Male patients must be
- •surgically sterile or using an acceptable method of contraception (defined as
- •barrier methods in conjunction with spermicides) for the duration of the study
- •(from the time they sign consent) and for 3 months after the last dose of
- •AZD4831/matching placebo to prevent pregnancy in a partner. Male patients must
- •not donate or bank sperm during this same time period, Genetic sampling NA for
- •the Netherlands
排除标准
- •Creatinine clearance by Chronic Kidney Disease Epidemiology Collaboration
- •(CKD-EPI) eGFR <30 ml/min/1.73m2 or dialysis, Life expectancy <3 years due to
- •other reasons than cardiovascular disease, Any ongoing skin disorder, history
- •of, or ongoing clinically significant allergy/hypersensitivity, Current
- •decompensated HF, Primary cardiomyopathy (e.g. constrictive, restrictive,
- •infiltrative, toxic, hypertrophic, congenital or any primary cardiomyopathy) in
- •judgment of investigator, Current hemodynamically significant valve disease in
- •opinion of investigator, EF ever documented < 40%, Any current life-threatening
- •dysrhythmia, Probable alternative primary reason for patient\u2019s symptoms in
- •judgment of investigator, including but not limited to: a. Isolated pulmonary
- •arterial hypertension or right ventricular (RV) failure; in the absence of
- •left-sided HF b. Anaemia: Hb <100 mg/L (10g/dL) c. Severe chronic obstructive
- •pulmonary disease (COPD) or lung disease (chronic O2, nebulizer or oral steroid
- •therapy), Cardiac surgery, acute coronary syndrome (ACS), or non-elective
- •percutaneous coronary intervention (PCI) < 3 months, Known or clinically judged
- •significant macrovascular coronary artery disease (CAD) that has not been
- •revascularized, Heart transplantation or left ventricular assist device ever,
- •Patients with uncontrolled or clinically significant thyroid disease as judged
- •by the investigator, Alanine transaminase (ALT) or aspartate aminotransferase
- •(AST) \u22652 x upper limit of normal (ULN). Resampling will not be allowed
- •during the same screening period if detected abnormal values do not have
- •reasonable explanation and are not expected to return to normal level within
- •few days., Known positive HIV, hepatitis C antibody, hepatitis B virus surface
- •antigen or hepatitis B virus core antibody, at screening
研究者
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