None listed
Conditions
Brief summary
Heart failure is a common and serious problem in our community. It is unclear whether preventative treatment in people at high risk of heart failure, such as those with type 2 diabetes mellitus, works. Dapagliflozin is an anti-diabetic medication that has been shown to be effective in treating heart failure and reducing death. We are trying to determine whether using dapagliflozin in people with early features of heart failure prevents the progression of the condition.
Interventions
Participants will be randomised in a 1:1 ratio into two groups; intervention with dapagliflozin or placebo. Participants who are randomised into the dapagliflozin arm will receive the tablet at a dose of 10mg once daily. The total duration of treatment is 24 months. Adherence and compliance to the intervention will be evaluated at each follow-up visit.
Dapagliflozin is a sodium-glucose cotransporter-2 (SGLT2) inhibitor and is used in the treatment of type 2 diabetes mellitus. In clinical trials
Participants will be randomised in a 1:1 ratio into two groups; intervention with dapagliflozin or placebo. Participants who are randomised into the dapagliflozin arm will receive the tablet at a dose of 10mg once daily. The total duration of treatment is 24 months. Adherence and compliance to the intervention will be evaluated at each follow-up visit. Dapagliflozin is a sodium-glucose cotransporter-2 (SGLT2) inhibitor and is used in the treatment of type 2 diabetes mellitus. In clinical trials it has been effective in reducing hospitalisation from heart failure and cardiac death. It's use in this study is to determine whether it can reduce the progression of heart failure in at-risk patients with type 2 diabetes.
Sponsors
Baker Heart and Diabetes Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with type 2 diabetes aged over 65 years will be screened with an echocardiogram. Those with stage B heart failure will be included. Subclinical LV dysfunction on ECHO is defined as: 1. Global longitudinal strain (GLS) -16% or less; or 2. Borderline GLS (-18 to -16%) and impaired relaxation or left atrial (LA) enlargement); or 3. E/e' > 15; or 4. E/e' > 10 and LA enlargement; or 5. Abnormal relaxation and LA enlargement.
Exclusion criteria
- Unable to provide written informed consent to participate in this study - Participating in another clinical research trial where randomised treatment would be unacceptable - History of >moderate valvular heart disease - History of previous heart failure, hypertrophic cardiomyopathy - Current therapy with SGLT2 inhibitors and GLP-1 - Systolic blood pressure (BP) <110mmHg - Estimated glomerular filtration rate (eGFR) <45 - Baseline New York Heart Association (NYHA) classification >2 - Oncologic life expectancy < 12 months - Inability to acquire interpretable images (identified from baseline echo) - Pregnant or breast-feeding
Outcome results
None listed