EUCTR2015-000192-27-NO进行中（未招募）1 期
GutHeart: Targeting Gut microbiota to treat Heart failure
Oslo University Hospital0 个研究点目标入组 150 人开始时间: 2015年2月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
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
- 性别
- All
入选标准
- •18 = and <75 years of age
- •Clinical or symptomatic evidence of HF, in NYHA class II-III and LVEF
- •Signed informed consent and expected cooperation of the patients for
- •the treatment and follow-up must be obtained and documented
- •according to ICH GCP, and national/local regulations
- •Patients should be stabilized on state-of-art HF medication for more
- •than 3 months prior to inclusion
- •Acceptable acoustic windows for echocardiographic assessment
- •All of the following conditions must apply to the prospective patient at
- •screening prior to receiving study agent (e.g.):
- •Must be at least 18 years of age, and less than 75.
- •Have heart failure in New York Heart Association class II or III
- •Echocardiographically verified LVEF < 40 %.
- •On optimal treatment for at least 3 months
- •Must have lab values as the following:
- •Hemoglobin above 10 g/l
- •eGFR above 30 ml/min
- •ALT < 150 units/l
- •Signed informed consent and expected cooperation of the patients for
- •the treatment and follow up must be obtained and documented
- •according to ICH GCP, and national/local regulations.
- •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 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •Treatment with antibiotics or probiotics within the last 12 weeks
- •History of hypersensitivity to Rifaximin or other Rifamycin derived
- •antimicrobial agents, or any of the components of Xifaxan
- •(http://www.legemiddelverket.no/_layouts/Preparatomtaler/Spc/11-
- •8645.pdf?id=05122013165930).
- •History of hypersensitivity to S. boulardii, yeast, or any of the
- •components of Precosa
- •(http://www.legemiddelverket.no/_layouts/Preparatomtaler/Spc/1994
- •-02012.pdf?id=03042014142345).
- •Polypharmacia with increased risk for interactions. i.e. patient with
- •an extensive medication lists (e.g. 10 drugs or more) which may
- •influence with the patient safety or compromise the study results
- •Malignancy of any cause, excluding basal cell carcinoma of the skin
- •Acute coronary syndrome over the last 12 weeks
- •Severly impaired kidney function (i.e., estimated glomerulus filtration
- •rate < 30 ml/minute/1.73 m2)
- •Impaired liver function (Alanine aminotransferase > 150 U/l) or
- •decompensated liver cirrhosis classified as Child–Pugh B or C.
- •On-going infection, including GI infection
- •Inflammatory bowel disease
- •Bowel obstruction
- •Active myocarditis, including Chagas disease
- •Severe primary valvular heart disease
- •Atrial fibrillation with ventricular frequency > 100/min
- •Any other, severe comorbid disease that must be expected to severely
- •reduce the efficacy of the interventional products, survival or compliance
- •Treatment with immunosuppressive drugs
- •Treatment with rifamycins other than Rifaximin
- •Central venous catheter
- •Pregnancy or planned pregnancy
- •Poor compliance
- •Any reason why, in the opinion of the investigator, the patient should
- •not participate.
研究者
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