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 sites56 target enrollmentJuly 9, 2015

Overview

No summary available.

Registry

who.int

Start Date

July 9, 2015

End Date

August 11, 2017

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

niversity of Dundee/ NHS Tayside

•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

•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