2022-501682-45-00已完成4 期
The effect of empagliflozin on peripheral microvascular dysfunction in heart failure with preserved ejection fraction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Cutaneous vascular conductance (CVC) (Skin blood flow divided by the mean arterial pressure) as measured by LASCA
研究概览
简要总结
The primary objective of this study is to evaluate the effect of treatment with the SGLT-2 inhibitor empagliflozin after 3 months on peripheral microvascular function, defined as the cutaneous vascular conductance (CVC) in the forearm skin, measured by laser speckle contrast analysis (LASCA) during iontophoresis of achetylcholin, insulin and nitroprusside, in HFpEF patients
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •HFpEF diagnosis according to the ESC 2021 Guidelines for the diagnosis and treatment of acute and chronic heart failure
- •Ability to understand and speak the Dutch language
- •Treatment with empagliflozin 10mg once daily is planned to be started by the treating physician
- •Signed informed consent
排除标准
- •Unable or unwilling to sign informed consent
- •Under 18 years of age
- •Contra-indication to the use of empagliflozin
- •Use of empagliflozin or other SGLT-2 inhibitor at baseline
- •Insulin dependent patients (Fasting conditions cause a risk of ketoacidosis in these patients)
- •Subjects currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study
- •Any condition that interferes with the correct execution of the LASCA measurements (patient is unable to keep arms motionless during the measurements, any condition that does not allow disposables to be attached to the forearm skin)
- •Any other reason that makes it undesirable for patient to use empagliflozin according to the researcher / treating physician
结局指标
主要结局
Cutaneous vascular conductance (CVC) (Skin blood flow divided by the mean arterial pressure) as measured by LASCA
Cutaneous vascular conductance (CVC) (Skin blood flow divided by the mean arterial pressure) as measured by LASCA
次要结局
- Baseline bloodflow and area under the curve as measured by LASCA
- Cutaneous vascular conductance (CVC)
- Serum ketone levels in mmol/L
- EQ5D-5L questionnaire score
研究者
Principal Investigator
Scientific
University Hospital Maastricht
研究点 (1)
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