ISRCTN79322795进行中（未招募）2 期
A phase 2 double-blind randomised controlled trial studying the effect of sotagliflozin 200mg once daily versus placebo in individuals with heart failure and type 1 diabetes on quality of life measured using the Kansas City Cardiomyopathy Questionnaire
niversity of Dundee0 个研究点目标入组 320 人开始时间: 2024年3月12日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 320
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
- •1. Age 18 years to <85 years.
- •2. Type 1 diabetes.
- •3. Insulin dose =0.5 units/kg body weight at screening or BMI =25kg/m2 at screening
- •4. Using continuous glucose monitor at screening or willing to use one for the duration of the trial.
- •5. Diagnosis of heart failure (HF) regardless of left ventricular ejection fraction (LVEF), defined as one or more of the following:
- •5.1. Previous HF hospitalisation where HF was documented as the primary cause of hospitalisation and there was a requirement for loop diuretics
- •5.2. Impaired left ventricular (LV) function (i.e. LVEF <50% by any imaging modality) at any time
- •5.3. Preserved LV systolic function (LVEF =50%) with left atrial enlargement (2-dimensional echocardiographic measurement of left atrial width =3.8cm or left atrial length =5.0 cm or left atrial area =20cm2 or left atrial volume index >29 ml/m2) within the last 24 months.
- •5.4. Preserved LV systolic function (LVEF =50%) with left ventricular hypertrophy (2-dimensional echocardiographic measurement of end-diastolic interventricular septal diameter =1.2cm or end-diastolic left ventricular posterior wall diameter =1.2cm) within the last 24 months.
- •5.5. Preserved LV systolic function (LVEF =50%) with echocardiographic diastolic dysfunction (septal e’ <7cm/sec or lateral e’ <10cm/sec or average E/e’ =15) within the last 24 months.
- •6. New York Heart Association Class II-IV at screening.
- •7. Elevated N-terminal pro-B-type natriuretic peptide (=250 ng/L for those in sinus rhythm, =400 ng/L if in atrial fibrillation) or B-type natriuretic peptide (=75 ng/L for those in sinus rhythm, =100 ng/L if in atrial fibrillation) within 12 months of screening.
- •8. Kansas City Cardiomyopathy clinical summary score <85 at screening.
排除标准
- •Current exclusion criteria as of 12/03/2024:
- •1. Cardiac surgery (coronary artery bypass graft or valve replacement), type 1 myocardial infarction, implantation of cardiac device (including biventricular pacemaker) or cardiac mechanical support implantation within 1 month of screening, or between screening and randomisation, or planned during the trial.
- •2. End-stage heart failure requiring left ventricular assist devices, intra-aortic balloon pump, or any type of mechanical support at the time of randomisation.
- •3. Documented primary severe valvular heart disease, amyloidosis or hypertrophic cardiomyopathy as principal cause of heart failure as judged by the local investigator.
- •4. Respiratory disease thought to be the primary cause of dyspnoea as assessed by the local investigator.
- •5. Chronic kidney disease with estimated glomerular filtration rate <25ml/min/1.73m² at screening.
- •6. Moderate or severe hepatic impairment (e.g. Child-Pugh B and C) at screening as judged by the local investigator.
- •7. Use of sotagliflozin or any SGLT2 inhibitor within 1 month of screening or between screening and randomisation.
- •8. Previous hypersensitivity/intolerance to SGLT2 inhibitors.
- •9. Presence of malignancy with expected life expectancy <1 year at screening.
- •10. Severe hypoglycaemia (hospitalisation for hypoglycaemia or episode requiring external assistance to treat) within 1 month prior to screening or between screening and randomisation.
- •11. One episode of diabetic ketoacidosis or nonketotic hyperosmolar state within 1 month of screening or between screening and randomisation, or =2 diabetic ketoacidosis or nonketotic hyperosmolar state events within 6 months of screening.
- •12. Pregnant or lactating women.
- •13. Women of childbearing age or male partners of women of childbearing age and not practicing an acceptable method of birth control, see section 8.11
- •14. On a ketogenic diet.
- •15. Unwilling/unable to share glucose and ketone monitoring data.
- •16. Unwilling to wear continuous glucose monitoring during the trial.
- •17. Use of any investigational drugs within five times of the elimination half-life after the last dose or within 30 days, whichever is longer. Current enrolment in non-interventional, observational studies will be allowed.
- •Previous exclusion criteria:
- •1. Cardiac surgery (coronary artery bypass graft or valve replacement), type 1 myocardial infarction, implantation of cardiac device (including biventricular pacemaker) or cardiac mechanical support implantation within 1 month of screening, or between screening and randomisation, or planned during the trial.
- •2. End-stage heart failure requiring left ventricular assist devices, intra-aortic balloon pump, or any type of mechanical support at the time of randomisation.
- •3. Documented primary severe valvular heart disease, amyloidosis or hypertrophic cardiomyopathy as principal cause of heart failure as judged by the local investigator.
- •4. Respiratory disease thought to be the primary cause of dyspnoea as assessed by the local investigator.
- •5. Chronic kidney disease with estimated glomerular filtration rate <25ml/min/1.73m² at screening.
- •6. Severe hepatic impairment at screening as judged by the local investigator.
- •7. Use of sotagliflozin or any SGLT2 inhibitor within 1 month of screening or between screening and randomisation.
- •8. Previous hypersensitivity/intolerance to SGLT2 inhibitors.
- •9. Presence of malignancy with expected life expectancy <1 year at screening.
- •10. Severe hypoglycaemia
研究者
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