ISRCTN24885065进行中（未招募）Unknown
Ketone supplementation to improve cardiac energetics and function
niversity of Leeds0 个研究点目标入组 90 人开始时间: 2023年5月4日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Eligibility criteria for diabetes patients in this study:
- •1. Men and women >18 years of age
- •2. 6.0 <= HBA1c <= 10% at screening (for T2D cohort)
- •3. Ability and willingness to provide written informed consent and to comply with the requirements of the study
- •Eligibility criteria for patients with an established heart failure diagnosis:
- •1. Men and women >18 years of age
- •2. Ability and willingness to provide written informed consent and to comply with the requirements of the study
- •3. Prior diagnosis of non-ischemic heart failure
- •4. LV ejection fraction of <50% on prior CMR or echocardiography scans
- •5. For participants with T2D: 6.0 <= HBA1c <= 10% at screening
- •Eligibility criteria for the healthy volunteers:
- •1. Men and women >18 years of age
- •2. Mean HBA1c< = 6%
- •3. Ability and willingness to provide written informed consent and to comply with the requirements of the study
排除标准
- •Exclusion criteria for diabetes patients:
- •1. History of coronary artery disease, previous CABG, angioplasty or myocardial infarction
- •2. Known HF or reduced LVEF on baseline CMR (<50%)
- •3. Female participants who are pregnant, lactating or planning pregnancy during the course of the study
- •4. Renal impairment (eGFR <30 ml/min/m2)
- •5. Participation in a clinical trial in the preceding 12 weeks
- •6. Contra-indications to CMR or to dobutamine or gadolinium
- •7. Any type of diabetes other than T2D
- •Exclusion criteria for patients with established heart failure diagnosis:
- •1. Significant renal impairment (eGFR <30 ml/min/m2)
- •2. Female participants who are pregnant, lactating or planning pregnancy during the course of the study
- •3. Participation in a clinical trial of an investigational medicinal product in the preceding 12 weeks
- •4. Contra-indications to MRI
- •5. Known hypersensitivity to dobutamine or gadolinium
- •6. History of coronary artery disease, previous CABG, angioplasty or myocardial infarction
- •7. Any type of diabetes other than T2D
- •Exclusion criteria for healthy controls:
- •1. Any type of diabetes
- •2. Significant renal impairment (eGFR <30 ml/min/m2)
- •3. Female participants who are pregnant, lactating or planning pregnancy during the course of the study
- •4. Participation in a clinical trial of an investigational medicinal product in the preceding 12 weeks
- •5. Contra-indications to MRI
- •6. Known hypersensitivity to dobutamine or gadolinium
- •7. History of coronary artery disease, previous CABG, angioplasty or myocardial infarction
- •8. Known HF or reduced LVEF on baseline CMR (<50%)
研究者
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