Can Mineralocorticoid Receptor Antagonism Counteract Cardiometabolic Long-term Effects of Steroids? (MiRACCLES study)

Phase 2

Recruiting

Conditions: Cardiovascular - Other cardiovascular diseases
Metabolic and Endocrine - Metabolic disorders
Cardiometabolic complications of excess glucocorticoid exposure

Registration Number: ACTRN12622000671763

Lead Sponsor: Dr Moe Thuzar

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Female

Target Recruitment: 60

Inclusion Criteria

(i)female
(ii)age at least 18 years
(iii)requiring glucocorticoids (GC) therapy (equivalent to at least 7.5mg/day of prednisolone average) for at least the next 3 months
(iv)on nil or stable other systemic immunomodulatory drugs

Exclusion Criteria

any of the following -
(i)upright systolic blood pressure <100 mmHg
(ii)estimated glomerular filtration rate (eGFR) less than 60 ml/min
(iii)serum potassium more than 5mmol/L in a non-haemolysed blood sample
(iv)thyroid or endocrine dysfunction, other than diabetes
(v)significant organ dysfunction such as heart failure, liver failure
(vi)moderate-severe valvular or unstable ischaemic heart disease or rhythm disturbances

(vii) active malignancy
(viii)transplant recipient
(ix)undertaking a weight loss regimen or history of previous bariatric surgery
(x)pregnant or planning pregnancy, or not willing to use effective birth control measures throughout the study period while sexually active in a heterosexual relationship and of reproductive age
(xi)unable to provide informed consent

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in total body fat mass on dual-energy X-ray absorptiometry (DEXA)[ baseline, 12 weeks post intervention commencement (primary endpoint) and 24 weeks post intervention commencement];Change in left ventricular (LV) systolic function as assessed by global longitudinal strain (GLS) on echocardiogram[ baseline, 12 weeks post intervention commencement (primary endpoint) and 24 weeks post intervention commencement]

Secondary Outcome Measures