NL-OMON51060已完成不适用
A Non-Interventional Mechanistic Study to Characterize Biomarkers for Mitochondrial Dysfunction and Inflammation in Subjects with Mitochondrial Disorder and Cardiomyopathy, and Healthy Volunteers - Biomarkers in mitochondrial patients and healthy volunteers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •All subjects
- •1. Adults between 18 and 75 years, inclusive at screening
- •2. Body mass index (BMI) 18.0 to 30.0 kg/m2, inclusive at screening
- •3. Ability and willingness to abstain from alcohol at study visit
- •4. Subject (and/or parent/legal guardian) has voluntarily signed consent form.
- •5. Willingness and ability to comply with all study procedures.
- •6. Ability to communicate with the investigator in Dutch or English
- •Subjects of cohort 1 with Mitochondrial Disorder (in addition)
- •7. Diagnosis of Mitochondrial Disorder, confirmed by:
- •a. Genetic testing at any time prior to screening showing m.3243A>G mutation
- •b. Newcastle Mitochondrial Disease Scale (NMDAS) score *11
- •8. Any current cardiomyopathy (e.g., LVH, reduced systolic function or strain,
- •ECG abnormalities consistent with cardiac involvement etc.).
- •Subjects of cohort 2 Healthy Volunteers (in addition)
- •9. Judged to be in good health in the opinion of the Investigator on the basis
- •of a medical evaluation that reveals the absence of any clinically relevant
- •abnormality
- •10. Matching to MitoD group for age (+/- 5 years), gender, and BMI (+/- 3
排除标准
- •2. Women with positive urine hCG test at screening
- •3. Subject has a hemoglobin values outside the normal limits (as per local lab)
- •4. Subject has received drug therapy with any cytostatic, sGC
- •stimulator/activator or nitrate agent during the last 3 months
- •5. Subjects with severe aortic valve stenosis
- •6. Subject has received drug therapy with Metformin during last 3 months
- •7. Significant psychiatric or neurological disorder that would inhibit the
- •subject from being compliant with study procedures
- •15. Positive nasopharyngeal rapid antigen test for SARS-CoV-2 at admission to
- •the clinical research center
- •16. Subject has received any vaccination in the last 2 weeks prior to Visit 1
- •Subjects of cohort 2 Healthy Volunteers (in addition)
- •17. Subject has acute decompensated hepatic, gastrointestinal, respiratory,
- •cardiovascular, metabolic, immunological, or hormonal disorders.
研究者
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