EUCTR2016-001387-12-DE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
- •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
- •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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