Early detection and echocardiographic assessment of diabetic heart disease and the impact of neurohormonal inhibition

Conditions

None listed

Brief summary

The primary purpose is to assess the ability of new techniques of echocardiographic assessment of heart function in detecting early heart disease in patients with type II diabetes mellitus and to assess the impact of 12 month period of neurohormonal inhibition in improving heart muscle function and degree of scarring in these patients

Leung M, Wong VW, Heritier S, Mihailidou AS, Leung DY.

2013-10-018 citations

10.1186/1475-2840-12-139

Interventions

Eligible patients (about 130 patients) with type II diabetes mellitus with stable metabolic control will be randomised to elperenone or matching placebo. Initial dose will be one tablet a day orally (25 mg). The dose may be up titrated to 50 mg daily after 4 weeks if the lower dose is tolerated. All patients will be monitored regularly for side effects and blood tests will be obtained to monitor serum electrolytes levels and renal function. Treatment will be maintained for a minimum of 12 month

Eligible patients (about 130 patients) with type II diabetes mellitus with stable metabolic control will be randomised to elperenone or matching placebo. Initial dose will be one tablet a day orally (25 mg). The dose may be up titrated to 50 mg daily after 4 weeks if the lower dose is tolerated. All patients will be monitored regularly for side effects and blood tests will be obtained to monitor serum electrolytes levels and renal function. Treatment will be maintained for a minimum of 12 months. Heart muscle function and degree of scarring will be assessed with echocardiography at baseline and again at 12 months. Biomarkers levels of collagen synthesis will be assessed at baseline and at 12 months

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

Type II diabetes mellitus Stable metabolic control

Exclusion criteria

Severe heart failure Chronic kidney diseases (serum creatinine > 220 umol/L) Hyperkalaemia (serum potassium > 5 mmol/L) Addison's disease

Outcome results