Clinical and pathophysiological aspects of visualization of metabolic flux in the failing human heart using hyperpolarized [1-13C]-pyruvate cardiac magnetic resonance
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Metabolic in vivo flux through the PDC in the myocardium in humans. Co-primary endpoints are: a) [13C]-bicarbonate/[1-13C]-pyruvate ratio, b) [1-13C]-lactate / [1-13C]-pyruvate ratio and [1-13C]-lactate / [1-13C]-bicarbonate ratio. The latter gives ratio indices of PDC-mediated pyruvate oxidation and lactate production via lactate dehydrogenase.
研究概览
简要总结
To visualize and quantify pyruvate metabolism of the heart in patients with heart disease and correlate it to current clinical diagnostic scanning modalities.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Chronic heart failure (Heart failure with both reduced and preserved EF are allowed) > 18 years of age. Left ventricular Ejection Fraction (LVEF) of 10 – 60 % Adequate hematologic and organ function, i.e. ANC at least 1.500/uL Platelet count >100/uL Se creatinine up to 1.5 x UNL or creatinine clearance at least 30 ml/min 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. Non-insulin dependent Diabetes mellitus is allowed Danish speaking Able and willing to comply after informed consent For substudy 1A only: Ischemic heart disease and referral to viability testing at the Department of Clinical Physiology and Nuclear Medicine at Aarhus University Hospital, Skejby.
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 in study 1 (this does not apply for substudy 1A) Estimated Glomerular Filtration Rate (eGFR) <30 mL/min Insulin dependent Diabetes Mellitus Intolerance to Pyruvate
结局指标
主要结局
Metabolic in vivo flux through the PDC in the myocardium in humans. Co-primary endpoints are: a) [13C]-bicarbonate/[1-13C]-pyruvate ratio, b) [1-13C]-lactate / [1-13C]-pyruvate ratio and [1-13C]-lactate / [1-13C]-bicarbonate ratio. The latter gives ratio indices of PDC-mediated pyruvate oxidation and lactate production via lactate dehydrogenase.
Metabolic in vivo flux through the PDC in the myocardium in humans. Co-primary endpoints are: a) [13C]-bicarbonate/[1-13C]-pyruvate ratio, b) [1-13C]-lactate / [1-13C]-pyruvate ratio and [1-13C]-lactate / [1-13C]-bicarbonate ratio. The latter gives ratio indices of PDC-mediated pyruvate oxidation and lactate production via lactate dehydrogenase.
次要结局
未报告次要终点
研究者
Henrik Wiggers
Scientific
Region Midtjylland