Safety and Effectiveness of SGLT-2 Inhibitors in Patients With Heart Failure and Diabetes
Condition: Heart Failure; Diabetes
MeSH terms: Heart Failure; Diabetes Mellitus; Ventricular Remodeling
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients with diabetes are at increased risk of developing heart failure (HF) which can lead
      to increased shortness of breath, reduced ability to exercise and in some cases premature
      death as the heart becomes less efficient at pumping blood around the body. However the
      treatment options for such patients remain limited.

      This study will test the safety and benefits of using a new class of drug, the SGLT2
      Inhibitor (Dapagliflozin), in treating HF and diabetes.

      Participants will have a Magnetic Resonance Imaging (MRI) scan of the heart, to measure the
      efficiency and the extent of thickening of the heart muscle before they start on treatment of
      dapagliflozin, or placebo for one year. They will also do exercise testing on an exercise
      bike (if capable) and a walking test plus fill in some questionnaires on how their heart
      failure affects their quality of life. Participants will then continue as normal with
      currently prescribed medication for their diabetes and heart failure. After a year the tests
      will be repeated to determine if patients receiving Dapagliflozin benefited more than those
      who weren't on the drug.

      This study is funded by the European Foundation for the Study of Diabetes (EFSD)
    

Detailed description: 
      Men and women with diabetes have a 2-5-fold increased risk of heart failure (HF). The
      prevalence and incidence of HF is increasing in diabetes and mortality rates remain
      alarmingly high. This highlights the need for novel therapies in diabetes that will reduce HF
      risk and /or delay disease progression.

      Drug options are currently limited as some diabetic therapies such as thiazolidinediones are
      contra-indicated in HF. SGLT2 inhibitors, the newest class of anti-diabetic drugs, are an
      exciting new approach to diabetes management that may have additional beneficial effects in
      diabetes and HF. SGLT2 inhibitors may have beneficial effects on adverse left ventricular
      (LV) remodelling that occurs in patients with diabetes and heart failure by reducing the load
      on the heart through its diuretic and blood pressure lowering actions.

      Exercise intolerance is a cardinal symptom of patients with HF and improving insulin
      sensitivity has been shown to improve exercise capacity. SGLT2 inhibition has been shown to
      improve insulin sensitivity and to reduce weight and therefore has the potential to improve
      exercise capacity in HF.

      This study will assess the potential beneficial effects of the oral SGLT2 inhibitor,
      dapagliflozin, on LV remodelling and exercise capacity in patients with diabetes and HF. The
      findings of this study may help to establish the utility of SGLT2 inhibitors in diabetic
      patients with HF and provide important clinical data on the impact of SGLT2 inhibition on LV
      remodelling.
    

Intervention name(s): Dapagliflozin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sodium Glucose Linked Transporter Type 2 (SGLT-2) Inhibitor; Capsules containing microcrystalline cellulose Ph Eur overencapsulated in a hard gelatine capsule shell to match the active comparator
Other intervention name(s): Forxiga
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Heart failure; Diabetes; Left ventricular remodelling; SGLT-2 inhibitors