Effects of Sodium Glucose Co-Transpoter-2 (SGLT-2) in diabetics with heart failure

• Conditions: Heart failure; Type 2 Diabetes; Cardiovascular - Other cardiovascular diseases; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12618000795291
• Lead Sponsor: Endcrinology Department, Box Hill Hospital - Eastern Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-10
• Study Completion: 2018-08-08
• Last Update Posted: 28 January 2019

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 2

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 .

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the cardiac function as a composite outcome of changes in serum biomarkers - troponin, high sensitivity CRP(hsCRP) and brain natriuretic peptide(BNP) levels[6 months from time of initiation of SGLT-2 inhibitor.]

Secondary Outcome Measures

Name	Time	Method
Change in self reported symptoms as assessed by changes in the scores for Minnesota Living with Heart Failure Questionnaire.[6 months from time of initiation of SGLT-2 inhibitor.];Change in functional class as assessed by changes in NYHA functional class[6 months from time of initiation of SGLT-2 inhibitor.];Change in serum troponin[6 months from time of initiation of SGLT-2 inhibitor.];Change in hsCRP measured by serum assay.[6 months from time of initiation of SGLT-2 inhibitor.];Change in BNP measured by serum assay[6 months from time of initiation of SGLT-2 inhibitor.]