ACTRN12616000619448招募中1 期
Safety and Efficacy study of CRD-102 in patients with Heart Failure with Preserved Ejection Fraction
Cardiora pty Ltd0 个研究点目标入组 24 人开始时间: 2016年5月12日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1.Subject is willing and able to provide informed consent
- •2.Subject is willing and able to comply to all protocol requirements and procedures, including visits
- •3.Males and Females 18 years of age or older
- •4.Patients with symptoms of heart failure (NYHA III)
- •5.LVEF>40% at screening
- •6.HF Hospitalisation within 12 months or NT-BNP>400pg/mL (in SR) or NT-BNP>600pg/mL (in AF)
- •7.Septal E/e’>12 and <20
- •8.Left atrial volume index >28ml/m2
- •9.Stable medical therapy including diuretics for 2 weeks
- •If subject is female of childbearing potential, the subject agrees to use an accepted form of contraception throughout the study, including follow-up. (Women who are post-menopausal for at least 2 years or are surgically sterile are not considered to be of childbearing potential.)
排除标准
- •1.Subject has had a myocardial infarct (MI) within 90 days before Screening
- •2.Subject is listed for heart transplant or a LVAD
- •3.Subject has a systolic blood pressure less than 90 mm Hg at time of screening
- •4.Subject has undergone cardiac surgery within the 60 days before screening
- •5.Subject is suspected of having symptoms primarily related to pericardial disease as suggested by relevant imaging or hemodynamic features
- •6.Subject has a moderate or greater degree of cardiac valvular stenosis or regurgitation
- •7.Subject has, at screening, clinically significant hepatic disease (serum total bilirubin equal to 3.0 mg/dL [= 51.3 micromol/L]), renal disease (eGFR less than 30 mL/min), or hematologic, gastrointestinal, immunologic, endocrine, metabolic, or central nervous system disease
- •8.Subject is symptomatically too unwell to be considered for trial, as evidenced by 6MWT less than 150m
- •9.Symptomatic ventricular arrhythmia or ICD firing within 90 days before screening
- •10.Poorly controlled atrial fibrillation (resting heart rate greater than 100 bpm)
- •11.Subjects who are receiving flecainide, encainide, propafenone, dofetilide, or disopyramide up to 2 weeks prior to screening
- •12.Subjects who have received within 7 days before the Screening or dosing visits:
- •a.An IV positive inotropic agent
- •b.A human B-type natriuretic peptide, including nesiritide
- •c.An oral or IV phosphodiesterase III inhibitor (PDEI III), including levosimendan and cilostazol
- •13.Subjects who have the following laboratory results at screening
- •a.Serum potassium concentration less than 4.0 or greater than 5.5 mEq/L
- •b.Serum magnesium concentration less than 1.0 mEq/L
- •c.Serum digoxin concentration less than 1.2 ng/mL
- •14.Female subjects who are pregnant and/or lactating
研究者
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