Mineralocorticoid Receptor Antagonism Clinical Evaluation in Atherosclerosis Trial
| Status: | Recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 41 - Any |
| Updated: | 4/17/2018 |
| Start Date: | January 2016 |
| End Date: | December 2021 |
| Contact: | Heather Conger |
| Email: | Heather.Conger2@uhhospitals.org |
| Phone: | 216-866-6550 |
Atherosclerotic disease, or hardening of the arteries, is characterized by the thickening of
the arterial walls due to fatty deposits in wall and inflammation in the wall of arteries.
High cholesterol, high blood pressure, diabetes, obesity and genetics play an important role
in developing clinical symptoms of atherosclerosis disease. The complications of advanced
atherosclerosis are chronic, slowly progressive and cumulative, resulting in heart attack,
stroke and/or death and blockage of arteries.
This study is being done to assess the effectiveness of Spironolactone therapy to slow down
the worsening of atherosclerotic disease (hardening of the arteries) in aorta (this is a
large vessel coming out of your heart) compared to placebo (look alike sugar pill). This will
be checked by comparing before and after therapy magnetic resonance imaging (MRI) pictures of
your aortic wall.
Spironolactone is an FDA approved drug used to treat heart failure and in the management of
hypertension (high blood pressure), but in this study it is used for another unapproved
reason. In this study, we would like to evaluate the effects of Spironolactone in people with
diabetes and atherosclerotic disease.
the arterial walls due to fatty deposits in wall and inflammation in the wall of arteries.
High cholesterol, high blood pressure, diabetes, obesity and genetics play an important role
in developing clinical symptoms of atherosclerosis disease. The complications of advanced
atherosclerosis are chronic, slowly progressive and cumulative, resulting in heart attack,
stroke and/or death and blockage of arteries.
This study is being done to assess the effectiveness of Spironolactone therapy to slow down
the worsening of atherosclerotic disease (hardening of the arteries) in aorta (this is a
large vessel coming out of your heart) compared to placebo (look alike sugar pill). This will
be checked by comparing before and after therapy magnetic resonance imaging (MRI) pictures of
your aortic wall.
Spironolactone is an FDA approved drug used to treat heart failure and in the management of
hypertension (high blood pressure), but in this study it is used for another unapproved
reason. In this study, we would like to evaluate the effects of Spironolactone in people with
diabetes and atherosclerotic disease.
Inclusion Criteria:
1. Male or female patients >45 or >40 years with known atherosclerotic events (examples
include MI, Stroke) and able to provide informed consent (females must be either
post-menopausal for one year, surgically sterile, or using effective contraception.
Oral contraceptives are disallowed.
2. Patients with Type II Diabetes with HbA1c ≤ 9.0 on stable anti-glycemic regimen that
may include oral and/or injectable therapy (GLP-1/Insulin etc.). Changes in dose of
glycemic regimen is allowed during the course of the trial if felt to be clinically
appropriate.
3. 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.
4. Patients must be on ACE and/or ARB therapy with no planned dose adjustments.
Exclusion Criteria:
1. Uncontrolled hypertension (SBP>160 and/or DBP>95 mmHg at visit 0 (screening) and SBP
>145 mm Hg at visit 2).
2. GFR (MDRD) of <15 at Visit 0 (screening).
3. Hyperkalemia defined as serum K+≥ 5.1 meq/L at visit 0 (screening).
4. LDL cholesterol >150 mg/dl.
5. Plasma triglycerides >400 mg/dl.
6. Contraindications to MRI (metallic implants, severe claustrophobia).
7. Acute coronary syndrome, Transient ischemic attack, CVA or critical limb ischemia
during the last 6 months or coronary/peripheral revascularization within the last 3
months.
8. Evidence of a secondary form of hypertension.
9. Initiation of new therapy with statins, ACEI/ARB, anti-oxidants, CCBs, diuretics, β
blockers.
10. Type I diabetes mellitus
11. Known contraindication, including history of allergy to Spironolactone.
12. . Any surgical or medical condition which might alter pharmacokinetics of drug (e.g.
renal transplant, liver failure, liver transplant).
13. Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia.
14. Significant hyponatremia defined as Na <130 meq/L.
15. History of prior malignancy including leukemia and lymphoma (but not basal cell skin
cancer, cured squamous cell cancer and localized Prostate cancer).
16. History of any severe, life-threatening disease.
17. Any surgical or medical conditions which places the patient at higher risk derived
from his/her participation into the study, or likely to prevent patient from complying
with requirements.
18. History of drug abuse within the last 2 years, noncompliance and
unwillingness/inability to consent.
19. Pregnant women and nursing mothers.
20. Class III or IV Congestive Heart Failure.
21. Primary Hyperaldosteronism.
We found this trial at
1
site
Cleveland, Ohio 44012
Principal Investigator: Sanjay Rajagopalan, MD
Phone: 216-866-6550
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