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Mineralocorticoid Receptor Antagonist

Spironolactone for Atherosclerosis

Phase 4
Waitlist Available
Led By Sanjay Rajagopalan
Research Sponsored by University Hospitals Cleveland Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 56 weeks
Awards & highlights

Study Summary

This trial is testing whether spironolactone can help slow the worsening of atherosclerotic disease in people with diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~56 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 56 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent Change in Atheroma Volume (PAV) in the Thoracic Aorta of Spironolactone vs. Placebo
Secondary outcome measures
Change in 24-hour Ambulatory Systolic Blood Pressure of Spironolactone vs. Placebo
Left Ventricular Mass Index of Spironolactone vs. Placebo.
Measures of Insulin Resistance (HOMA-IR) of Spironolactone vs. Placebo
+1 more

Side effects data

From 2022 Phase 4 trial • 79 Patients • NCT02169089
8%
Hypotension
5%
Diabetes related
5%
Hyperkalemia
5%
Infection
3%
Chest pain/discomfort
3%
Breast tenderness/Gynecomastia
3%
Surgical
100%
80%
60%
40%
20%
0%
Study treatment Arm
Spironolactone
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SpironolactoneExperimental Treatment1 Intervention
Spironolactone
Group II: PlaceboPlacebo Group1 Intervention
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spironolactone
2005
Completed Phase 4
~7340

Find a Location

Who is running the clinical trial?

University Hospitals Cleveland Medical CenterLead Sponsor
317 Previous Clinical Trials
340,178 Total Patients Enrolled
2 Trials studying Atherosclerosis
128 Patients Enrolled for Atherosclerosis
University of MarylandOTHER
160 Previous Clinical Trials
302,204 Total Patients Enrolled
University of TorontoOTHER
690 Previous Clinical Trials
1,019,564 Total Patients Enrolled
1 Trials studying Atherosclerosis
41 Patients Enrolled for Atherosclerosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Mineralocorticoid Receptor Antagonism Clinical Evaluation in Atherosclerosis Trial
Sanjay Rajagopalan 2016. "Mineralocorticoid Receptor Antagonism Clinical Evaluation in Atherosclerosis Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02169089.
~9 spots leftby Apr 2025
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