Research into the Effect Of SGLT2 inhibition on left ventricular Remodelling in patients with heart failure and diabetes Mellitus - The REFORM Trial

niversity of Dundee/ NHS Tayside0 个研究点目标入组 56 人开始时间: 2015年7月9日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•are aged 18 years or over
•were previously diagnosed with Type 2 Diabetes
•are diagnosed with NYHA functional I-II Heart Failure (HF) with prior echocardiographic evidence of LVSD
•on furosemide 40mg daily or less, or equivalent loop diuretic
•have stable HF symptoms for at least three months prior to consent
•on stable therapy for HF for at least three months prior to consent
•have not been hospitalised for HF for at least three months prior to consent
•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 15
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 43

•severe hepatic disease
•renal disease defined as CKD class 3B or worse (i.e. eGFR<60ml/min)
•systolic BP <95mmHg at screening visit
•screening HbA1c <6.0%
•unable to walk to perform cardio pulmonary exercise testing or 6MWT
•on insulin, meglitinides eg, repaglinide, or 2nd generation sulphonylureas, eg glipizide
•malignancy (receiving active treatment) or other life threatening diseases
•pregnant or lactating women
•any contraindication to MRI (e.g. claustrophobia, metal implants, penetrative eye injury or exposure to metal fragments in eye requiring medical attention)
•patients who have participated in any other clinical trial of an investigational medicinal product within the previous 30 days
•patients who are unable to give informed consent
•any other reason considered by a study physician to be inappropriate for inclusion.

发起方

niversity of Dundee/ NHS Tayside