EUCTR2018-003533-15-DK进行中（未招募）1 期
Clinical and pathophysiological aspects of visualization of metabolic flux in the failing human heart using hyperpolarized [1-13C]-pyruvate cardiac magnetic resonance
Department of Cardiology, Aarhus University Hospital0 个研究点目标入组 60 人开始时间: 2018年11月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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
- •Dilated Cardiomyopathy
- •> 18 years of age.
- •Diagnosis of Dilated Cardiomyopathy (DCM)
- •Left ventricular Ejection Fraction (LVEF) of 10 – 45 %
- •Adequate hematologic and organ function, i.e.
- •ANC at least 1.500/uL
- •Platelet count >100/uL
- •Se bilirubin <1.5 UNL
- •ASAT, ALAT and AP up to 2.5 x UNL
- •Se creatinine up to 1.5 x UNL or creatinine clearance at least 30 ml/min
- •INR and aPTT at most 1.5 x UNL, except for patients on AK treatment
- •Women who are not postmenopausal or surgically sterile must have a negative serum or urine pregnancy test performed at time of inclusion in the study. Safe and highly effective contraception must be used throughout the study meaning either hormonal anti-conception or an anti-fertility intrauterine device. If the partner is non fertile or the patient has no sexual activities, this is also accepted.
- •Danish speaking
- •Able and willing to comply after informed consent
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •Not able or willing to receive heart failure therapy
- •Patients not willing to participate
- •Uncontrolled serious medical condition, such as uncontrolled heart
- •disease, uncontrolled diabetes, intestinal obstruction, uncontrolled
- •hypertension, or recent cerebral ischemia
- •Receiving more than 50% of taget dose of ACE-inhibitor and
- •betablockers before inclusion
- •Previous heart surgery including PCI
- •Estimated Glomerular Filtration Rate (eGFR) <30 mL/min
- •Diabetes Mellitus
- •Intolerance to Pyruvate
研究者
相似试验
已完成
Unknown
Visual disturbances and neurological changes after stays in space - a study of possible countermeasuresMuscular atrophy, bone loss, deconditioning of the cardiovascular system, deterioration of the vestibular system, deterioration of cognitive performance, fluid shifts, eye changes, SANSDRKS00030848DLR- Deutsches Zentrum für Luft- und Raumfahrt / Institut für Luft- Und Raumfahrtmedizin24
尚未招募
Unknown
Comparison of pain and functional outcome in vertebrae fracture after balloon kyphoplastyCTRI/2023/08/057044Jawaharlal Nehru Medical College
已完成
不适用
Symptoms, visual function, and mucin expression of eyes with an unstable tear filmdry eye syndromeJPRN-UMIN000009670Tokyo Dental College Ichikawa General Hospital60
招募中
不适用
Report of clinical findings in the vitreo-retinal diseasesJPRN-UMIN000007649Department of Ophthalmology, Keio University, School of Medicine400
已完成
不适用
Study on pathophysiology and clinical features of intractable and rare hepatobiliary and pancreatic disease and prognosis after treatmentpancreaticobiliary maljunctionJPRN-UMIN000042732Osaka City University24