EUCTR2015-002673-38-GB进行中（未招募）1 期
A multicenter, randomized, double-blind, crossover placebo-controlled Phase II study to assess the effect of serelaxin versus placebo on high sensitivity cardiac troponin I (hs-cTnI) release in patients with chronic heart failure after exercise when used in addition to standard of care
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 26
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
- •1. Provide written informed consent before any assessment is
- •2. Male or female = 18 years of age, with body weight = 160 Kg.
- •3. Diagnosis of stable CHF:
- •- New York Heart Association (NYHA) functional Class II and III.
- •- Receiving guideline-recommended treatment for CHF.
- •4. Left ventricular ejection fraction < 50%.
- •5. NT-proBNP > 250 ng/L in sinus rhythm or > 750 ng/L if not in sinus
- •rhythm (determined locally).
- •6. Ability to exercise for at least 10 to 12 minutes based on
- •investigator's judgment.
- •7. Systolic BP = 125 mmHg at screening.
- •8. Renal function defined as an eGFR of = 25 mL/min/1.73 m2 at
- •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 75
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1. Dyspnea primarily due to non-cardiac causes.
- •2. Worsening symptoms, e.g., fatigue, dyspnea, breathlessness within the 3 months prior to screening.
- •3. Increased risk of developing hypotension during vasodilator therapy according to investigators judgement.
- •4. Any contraindication for exercise testing and spirometry.
- •5. Stopping of the spirometry at screening according to the stopping rules, unless the patient has reached maximum exercise capacity defined as carbon dioxide production/oxygen consumption (VCO2/VO2) > 1.05.
- •6. Change in guideline-recommended CHF treatment within 1 month prior to screening.
- •7. Clinical evidence of acute coronary syndrome within 90 days prior to enrollment.
- •8. Significant arrhythmias, which include any of the following: sustained ventricular tachycardia, bradycardia with sustained ventricular rate < 45 beats per minute or atrial fibrillation/flutter with sustained ventricular response of > 90 beats per minute at rest.
- •9.Severe renal impairment defined as eGFR < 25 mL/min/1.73m2 before randomization.
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