EUCTR2016-003968-39-GB进行中（未招募）1 期
Renal and Cardiovascular Effects of SGLT2 inhibition in combination with loop diuretics in diabetic patients with chronic heart failure. - The RECEDE-CHF Trial
niversity of Dundee/NHS Tayside0 个研究点目标入组 23 人开始时间: 2018年5月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 23
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
- •Aged 18 to 80 years with previously diagnosed Type 2 Diabetes Mellitus.
- •Are diagnosed with NYHA Functional class II-III HF with prior echocardiographic evidence of LVSD.
- •On stable doses of furosemide, or alternative loop diuretic for at least one month.
- •Stable Type 2 Diabetes (HbA1c, in the last 3 months, of 6.5% = and =10.0%)
- •eGFR = 45 ml/min.
- •Have stable HF symptoms for at least three months prior to consent
- •On stable HF therapy for at least three months prior to consent
- •Have not been hospitalised for HF for at least three months prior to consent.
- •Women of childbearing potential (WoCBP) must agree to take precautions to avoid pregnancy throughout the trial and for 4 weeks after intake of the last dose.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 17
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 17
排除标准
- •A diagnosis of chronic liver disease and/or liver enzymes that are twice the upper limit of normal
- •Systolic BP of <95mmHg at screening visit.
- •Participants on thiazide diuretics.
- •Participants receiving renal dialysis
- •Participants who have previously had an episode of diabetic ketoacidosis.
- •Participants with type 1 diabetes mellitus
- •Malignancy (receiving active treatment) or other life threatening disease.
- •Pregnant or lactating women
- •Participants with difficulty in micturition e.g. severe prostate enlargement
- •Allergy to any SGLT2 inhibitor or lactose or galactose intolerance
- •Past or current treatment with any SGLT2 inhibitor
- •Participants who have participated in any other clinical interventional trial of an investigational medicinal product within 30 days.
- •Participants who are unable to give informed consent
- •Any other reason considered by the physician to be inappropriate for inclusion.
研究者
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