None listed
Conditions
Brief summary
Background: Patients with type 2 diabetes mellitus area at a higher risk of developing heart failure and a significant number of patients with established heart failure are receiving treatment for type 2 diabetes mellitus. The EMPA-REG OUTCOME study concluded that the inclusion of empagliflozin in the treatment received by patients with a high risk for cardiovascular events reduced the rate of primary adverse cardiovascular outcomes and mortality. Aim: The aim of this study is to test the hypothesis that treatment with sodium-glucose co-transporter 2(SGLT-2) inhibitors will decrease the risk, progression and severity of heart failure and also if there is any benefit in the quality of life in these patients following the addition of a SGLT-2 inhibitor as part of standard medical care. Methods: Participants will be recruited from the diabetes clinics at Box Hill and Maroondah Hospitals. These patients will have been identified by their treating physicians as suitable for SGLT-2 inhibitors. The SGLT-2 inhibitors (dapaglifozin or ertuglifozin) will be started in the course of normal clinical practice and according to existing clinical guidelines. The SGLT-2 inhibitor will be added to additional therapy or substituted for additional therapy at the discretion of the treating physician. Baseline blood tests and a Living with Heart failure questionnaire will be completed by the patients. Treatment will be monitored and further changes to therapy, the addition of other agents or the discontinuation of other agents, including SGLT-2 inhibitors, will also be at the discretion of the treating physician. Audit information will be collected prospectively but no information will be collected that is not a normal part of clinical practice in patients with heart failure. Recruitment of the participants will be by the registrars/consultants from the diabetes clinics after a thorough discussion about the safety of SGLT2 inhibitors and with full consent by the patient.
Interventions
The aim of this study is to test the hypothesis that treatment with sodium-glucose co-transporter 2(SGLT-2) inhibitors will decrease the risk, progression and severity of heart failure and also if there is any benefit in the quality of life in these patients following the addition of a SGLT-2 inhibitor to standard medical care.
Exposure:
The patients will be recruited from the Endocrinology Clinics at Eastern Health - Box Hill Hospital and Maroondah Hospital. All patients meeting the inclusion
The aim of this study is to test the hypothesis that treatment with sodium-glucose co-transporter 2(SGLT-2) inhibitors will decrease the risk, progression and severity of heart failure and also if there is any benefit in the quality of life in these patients following the addition of a SGLT-2 inhibitor to standard medical care. Exposure: The patients will be recruited from the Endocrinology Clinics at Eastern Health - Box Hill Hospital and Maroondah Hospital. All patients meeting the inclusion criteria will have medical history and physical examination performed, baseline blood tests and functional status as assessed by the Minnesota Living with Heart failure questionnaire. SGLT-2 inhibitors (dapaglifozin or empaglifozin) will be started in the course of normal clinical practice and according to exisiting guidelines. The SGLT-2 inhibitor will be added to additional therapy or substituted for additional therapy at the discretion of the treating physician. They will be followed up over the period of 6 months and the blood tests will be repeated. The quality of life will be assessed again using the Minnesota Living with Heart failure questionnaire. The blood tests include: hsCRP, troponin, BNP, HbA1c
Sponsors
Endcrinology Department, Box Hill Hospital - Eastern Health
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
- Patients aged between 18 and 85 with established heart failure (New York Heart Association Class II, III, IV) AND - Receiving treatment for type 2 diabetes mellitus with metformin, a sulphonylurea, a dual oral therapy, a combination of insulin and oral agents or insulin alone in cases where oral antidiabetic medications are contraindicated. - The HbA1c measurements of participants should be greater than 7.0% and obtained within the preceding 4 months. - Endocrinology team have assessed and deemed the patient suitable to be commenced on SGLT-2 inhibitors as per current guidelines.
Exclusion criteria
- Patients with type 1 diabetes mellitus, stage 3B, 4 and 5 chronic kidney disease (including patients on dialysis), galactose intolerance and a history of alcohol misuse, ketoacidosis or recurrent genitourinary infections. - Patients already receiving treatment with a dipeptidyl peptidase 4 inhibitor, thiazolidinedione or a glucagon-like peptide-1 .
Outcome results
None listed