MINERALOCORTICOID RECEPTOR ANTOGONISM IN ATHEROSCLEROSIS (MAGMA-ADDON)
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Atherosclerosis
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Age: Between 40 - 80 Years
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Gender: Male or Female
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Other Inclusion Criteria:
- Subjects able to provide informed consent
- Subjects who are > 45 years or >40 years with known atherosclerotic events (example MI, Stroke)
- Female subjects who must be either post-menopausal for one year, surgically sterile, or using effective contraception. Oral contraceptives are disallowed.
- Subjects with type II diabetes with HbA1c =9.0 on stable anti-glycemic regimen that may include oral and/or injectable therapy
- Subjects with GFR <90 and evidence of proteinuria (Urine Albumin/Creatinine Ratio of >30 mg/g or equivalent) in a urine specimen within 12 months OR GFR <60 mg/g regardless of proteinuria
- Subjects must be on ACE and/or ARB therapy with no planned dose adjustments
You may not be eligible for this study if the following are true:
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- Subjects with Uncontrolled hypertension
- Subjects with laboratory test results as per the protocol
- Subjects with contradictions to MRI
- Subjects with acute coronary syndrome, Transient ischemic attack, CVA or critical limb ischemia during the last 6 months or coronary/peripheral revascularization
- Subjects with evidence of a secondary form of hypertension.
- Subjects who has initiation of new therapy with statins, ACEI/ARB, antioxidants, CCBs, diuretics, ß blockers.
- Subjects with known contraindication, including history of allergy to Spironolactone
- Subjects with Type I diabetes mellitus
- Subjects with any surgical or medical condition which might alter pharmacokinetics of drug a/li>
- Subjects with concurrent potentially life threatening arrhythmia or symptomatic arrhythmia.
- Subjects with significant hyponatremia defined as Na <130 meq/L.
- Subjects with history of prior malignancy including leukemia and lymphoma
- Subjects with history of any severe, life-threatening disease.
- Subjects with any surgical or medical conditions which place the patient at higher risk derived from his/her participation into the study, or likely to prevent patient from complying with requirements
- Subjects with history of drug abuse within the last 2 years, noncompliance and unwillingness/inability to consent.
- Subjects who are pregnant and nursing mothers
- Subjects who have Class III or IV Congestive Heart Failure
- Subjects with Primary Hyperaldosteronism
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.