MAGMA

Trial question
What is the role of mineralocorticoid receptor antagonists in preventing aortic plaque progression and reducing LV mass and fibrosis in patients with T2DM and CKD?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
42.0% female
58.0% male
N = 79
79 patients (33 female, 46 male).
Inclusion criteria: patients with high-risk T2DM with CKD on maximum tolerated renin-angiotensin system blockade.
Key exclusion criteria: uncontrolled hypertension; secondary hypertension; hyperkalemia; LDL-C > 150 mg/dL; plasma triglycerides > 300 mg/dL; history of acute coronary or cerebrovascular syndrome or critical limb ischemia in the past 6 months; coronary or peripheral revascularization in the past 3 months; history of allergy to spironolactone; contraindication or intolerance to MRI.
Interventions
N=37 spironolactone (at an oral dose of 25 mg/day).
N=42 placebo (matching placebo).
Primary outcome
Absolute thoracic aortic wall volume change at 12 months
0.037 cm³
1.2 cm³
1.2 cm³
0.9 cm³
0.6 cm³
0.3 cm³
0.0 cm³
Spironolactone
Placebo
Significant decrease ▼
Significant decrease in absolute thoracic aortic wall volume change at 12 months (0.037 cm³ vs. 1.2 cm³; AD -1.163 cm³, 95% CI -2.16 to -0.17).
Secondary outcomes
Significant decrease in relative thoracic aortic wall volume change at 12 months (0.87% vs. 7.1%; AD -6.23%, 95% CI -11.83 to -0.63).
Significant decrease in LV mass at 12 months (-5.8 g vs. 3.1 g; AD -8.9 g, 95% CI -14.18 to -3.62).
Significant decrease in LV myocardial native T1 at 12 months (-10.1 ms vs. 26 ms; AD -36.1 ms, 95% CI -56.7 to -15.5).
Safety outcomes
No significant difference in SBP.
Significant difference in hyperkalemia-related discontinuation (3 vs. 0).
Conclusion
In patients with high-risk T2DM with CKD on maximum tolerated renin-angiotensin system blockade, spironolactone was superior to placebo with respect to absolute thoracic aortic wall volume change at 12 months.
Reference
Sanjay Rajagopalan, Mirela Dobre, Jean-Eudes Dazard et al. Mineralocorticoid Receptor Antagonism Prevents Aortic Plaque Progression and Reduces Left Ventricular Mass and Fibrosis in Patients With Type 2 Diabetes and Chronic Kidney Disease: The MAGMA Trial. Circulation. 2024 Aug 27;150(9):663-676.
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