EUCTR2016-001387-12-NL进行中（未招募）1 期
A randomized, subject and investigator-blind, placebo-controlled study of CLR325 in chronic stable heart failure patients. - CCLR325X2202
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
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
- •Written informed consent must be obtained before any assessment is performed.
- •Able to communicate well with the investigator, to understand and comply with the requirements of the study.
- •Male and female patients >18 years of age.
- •Patients must weigh between 50kg and 140 kg to participate in the study.
- •Patients with a cardiac ejection fraction of = 45% as assessed within the last 6 months.
- •For PA catheter cohorts, patients who are planned to have a clinically indicated pulmonary artery catheter in place prior to randomization.
- •In the opinion of the investigator, heart failure patients who will not
- •require a change in their dose of ACE, ARB, ß-blocker, mineralocorticoid receptor antagonist, or diuretic for 24 hours after
- •randomization
- •At baseline, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the sitting position after the subject has rested for at least five minutes.
- •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 40
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Presence of impaired renal function as indicated by clinically significant abnormal creatinine values (eGFR < 30 ml/min/1.73m^2 calculated using the MDRD equation).
- •Patients with values of AST or ALT >100 U/L measured within
- •the last 3 months before randomization.
- •Chronic infection with Hepatitis B (HBV) or Hepatitis C (HCV). A
- •positive Hepatitis B surface antigen (HBsAg) test excludes a
- •patient. Patients with a positive Hepatitis C antibody test should
- •have HCV RNA levels measured. Patients with positive
- •(detectable) HCV RNA should be excluded.
- •Patients with a history of chronic hepatitis of any non-cardiac
- •History of any active, clinically significant cardiac tachyarrhythmia, such as recurrent atrial fibrillation with rapid ventricular response within the last year. Anticoagulation for patients with atrial fibrillation should be managed per usual clinical practice for patients undergoing right heart catheterization.
- •For Echocardiography-based cohort only, patients admitted to an
- •inpatient setting for acute decompensated heart failure within the last
- •Patients who have received an intravenous infusion of a cardiac
- •inotrope (e.g.,dobutamine or milrinone) in the last 24 hours prior to
- •randomization.
- •For PA catheter cohorts, patients with a pulmonary capillary wedge
- •pressure of <10 mm Hg at baseline. For echocardiographic cohorts,
- •patients with a lateral E/E’ ratio of <7 on their baseline
- •echocardiogram. For patients in whom a lateral E/E’ ratio cannot be
- •determined (e.g., patients in atrial fibrillation), a central venous
- •pressure of <5mm Hg on baseline echocardiogram as determined by
- •inferior vena cava criteria.
- •Patients with any significant change in their dose of their ACE, ARB,
- •mineralocorticoid receptor antagonist, diuretic or ß-blocker within the
- •last 12 hours.
- •Patients with minor changes in their heart failure regimen may be eligible if deemed clinically stable by both the investigator and
- •Patients with known significant valvular heart disease, as indicated
- •by the following:
- •- Severe aortic stenosis (Aortic Valve Area < 1.0 cm^2 or peak
- •gradient > 50 mmHg as determined by echocardiography)
- •- Severe mitral stenosis
- •Patients with history of acute coronary syndrome within the last 60
- •days as determined by both clinical and enzymatic criteria.
研究者
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