Safety and Effectiveness of SGLT-2 Inhibitors in Patients With Heart Failure and Diabetes

Launched by UNIVERSITY OF DUNDEE · Mar 24, 2015

Keywords

ClinConnect Summary

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. ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • were previously diagnosed with Type 2 Diabetes
• • are diagnosed with NYHA functional class I-III HF with prior echocardiographic evidence of Left Ventricular Systolic Dysfunction (LVSD) (At least mild LV systolic dysfunction on sonographer assessment or ejection fraction at 45% or less)
• • on furosemide 80mg 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
• Exclusion Criteria:
• • severe hepatic disease
• • renal disease defined as Chronic Kidney Disease (CKD) class 3b or worse (i.e. estimated glomerular filtration rate (eGFR) / creatinine clearance CrCl \<45ml/min)
• • systolic BP \<95mmHg at screening visit
• • screening HbA1c \<6.0%
• • unable to walk to perform cardio pulmonary exercise testing or 6MWT
• • 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.