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Mineralocorticoid Receptor Antagonism Clinical Evaluation in Atherosclerosis Trial

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ClinicalTrials.gov Identifier: NCT02169089
Recruitment Status : Recruiting
First Posted : June 20, 2014
Last Update Posted : March 7, 2018
Sponsor:
Collaborators:
University of Maryland, College Park
University of Toronto
Winthrop University
Information provided by (Responsible Party):
Sanjay Rajagopalan, University Hospitals Cleveland Medical Center

Tracking Information
First Submitted Date  ICMJE June 18, 2014
First Posted Date  ICMJE June 20, 2014
Last Update Posted Date March 7, 2018
Study Start Date  ICMJE January 2016
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 19, 2017)
Percent change in atheroma volume (PAV) in the thoracic aorta of Spironolactone vs. placebo [ Time Frame: 56 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 18, 2014)
Percent change in atheroma volume (PAV) in the thoracic aorta of Eplerenone vs. placebo [ Time Frame: 56 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2017)
  • Central aortic blood pressure of Spironolactone vs. placebo. [ Time Frame: 56 weeks ]
  • 24-hour mean systolic blood pressure of Spironolactone vs. placebo [ Time Frame: 56 weeks ]
  • Pulse wave velocity (PWV) of Spironolactone vs. placebo [ Time Frame: 56 weeks ]
  • Measures of insulin resistance (HOMA-IR) of Spironolactone vs. placebo [ Time Frame: 56 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2014)
  • Central aortic blood pressure of Eplerenone vs. placebo. [ Time Frame: 56 weeks ]
  • 24-hour mean systolic blood pressure of Eplerenone vs. placebo [ Time Frame: 56 weeks ]
  • Pulse wave velocity (PWV) of Eplerenone vs. placebo [ Time Frame: 56 weeks ]
  • Measures of insulin resistance (HOMA-IR) of Eplerenone vs. placebo [ Time Frame: 56 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mineralocorticoid Receptor Antagonism Clinical Evaluation in Atherosclerosis Trial
Official Title  ICMJE Mineralocorticoid Receptor Antagonism Clinical Evaluation in Atherosclerosis Trial
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Atherosclerosis
Intervention  ICMJE
  • Drug: Spironolactone
    Patients will be given Spironolactone 12.5 mg on week 0 (visit 2). Patients will be escalated to 25 mg daily Spironolactone or maximal tolerated dose over a 4-week period. Patients will continue treatment for an additional 48 weeks.
    Other Name: Aldactone
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: Spironolactone
    Spironolactone
    Intervention: Drug: Spironolactone
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 21, 2016)
130
Original Estimated Enrollment  ICMJE
 (submitted: June 18, 2014)
150
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 41 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Heather Conger 216-866-6550 Heather.Conger2@uhhospitals.org
Contact: Steven Sawicki 216-844-7188 steven.sawicki@uhhospitals.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02169089
Other Study ID Numbers  ICMJE 57047
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanjay Rajagopalan, University Hospitals Cleveland Medical Center
Study Sponsor  ICMJE University Hospitals Cleveland Medical Center
Collaborators  ICMJE
  • University of Maryland, College Park
  • University of Toronto
  • Winthrop University
Investigators  ICMJE
Principal Investigator: Sanjay Rajagopalan Chief, Cardiovascular Medicine
PRS Account University Hospitals Cleveland Medical Center
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP