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:

  • Conditions:
    Atherosclerosis
  • Age: Between 40 - 80 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Subjects able to provide informed consent
    2. Subjects who are > 45 years or >40 years with known atherosclerotic events (example MI, Stroke)
    3. Female subjects who must be either post-menopausal for one year, surgically sterile, or using effective contraception. Oral contraceptives are disallowed.
    4. Subjects with type II diabetes with HbA1c =9.0 on stable anti-glycemic regimen that may include oral and/or injectable therapy
    5. 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
    6. 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:

    1. Subjects with Uncontrolled hypertension
    2. Subjects with laboratory test results as per the protocol
    3. Subjects with contradictions to MRI
    4. Subjects with acute coronary syndrome, Transient ischemic attack, CVA or critical limb ischemia during the last 6 months or coronary/peripheral revascularization
    5. Subjects with evidence of a secondary form of hypertension.
    6. Subjects who has initiation of new therapy with statins, ACEI/ARB, antioxidants, CCBs, diuretics, ß blockers.
    7. Subjects with known contraindication, including history of allergy to Spironolactone
    8. Subjects with Type I diabetes mellitus
    9. Subjects with any surgical or medical condition which might alter pharmacokinetics of drug a/li>
    10. Subjects with concurrent potentially life threatening arrhythmia or symptomatic arrhythmia.
    11. Subjects with significant hyponatremia defined as Na <130 meq/L.
    12. Subjects with history of prior malignancy including leukemia and lymphoma
    13. Subjects with history of any severe, life-threatening disease.
    14. 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
    15. Subjects with history of drug abuse within the last 2 years, noncompliance and unwillingness/inability to consent.
    16. Subjects who are pregnant and nursing mothers
    17. Subjects who have Class III or IV Congestive Heart Failure
    18. Subjects with Primary Hyperaldosteronism



If you are registered as a volunteer, please login to the dashboard to send referrals.

Contact the research team to learn more about this study.

By clicking "Contact Research Team", your contact information will be sent securely to the research staff associated with the study. You will also receive a copy of this email in your inbox, as well as other notifications to determine your participation status in the study.