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NCT03597035: MAGMAAddOn
Mineralocorticoid Receptor Antagonism Clinical Evaluation in Atherosclerosis Add-On
Phase 4 trial testing Spironolactone in Type2 Diabetes in 8 participants. Terminated before completion.
23 July 2020
Quick facts
| Lead sponsor | University Hospitals Cleveland Medical Center |
|---|---|
| Phase | Phase 4 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 8 |
| Start date | 17 July 2018 |
| Primary completion | 23 July 2020 |
| Estimated completion | 31 July 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Spironolactone (spironolactone) — full drug profile →
Conditions studied
- Type2 Diabetes — all drugs for Type2 Diabetes →
- Hyperkalemia — all drugs for Hyperkalemia →
Sponsor
University Hospitals Cleveland Medical Center
Who can join
45 and older, any sex, with Type2 Diabetes or Hyperkalemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Patiromer add-on to a mineralocorticoid receptor antagonist (MRA) in patients with Type 2 diabetes mellitus and chronic kidney disease (CKD) will reduce blood pressure and left ventricular (LV) mass to a greater extent compared to patients with MRA alone and favorably affect key secondary hemodynamic and inflammatory variables including atherosclerosis progression. Atherosclerosis is the leading cause of morbidity and mortality in Type II diabetes. A cell type called the monocyte/macrophage is critical to development and complications of atherosclerosis. This project will evaluate the effectiveness of a medication called Spironolactone in addition to Patiromer in preventing atherosclerosis in Type II diabetes through its effects on cells such as the monocyte. Spironolactone has been demonstrated to be effective for the treatment of patients after a heart attack and stroke. The investigators will evaluate the impact of Spironolactone in combination with Patiromer in reducing atherosclerosis plaque and additionally evaluate its potential in changing inflammation. The investigators envision that a strategy of simultaneously probing effect of a drug combined with analysis of mechanisms of action and predictive response will likely provide key information with which to design hard event (heart attack, stroke etc.) based trials.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03597035
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03597035 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospitals Cleveland Medical Center
- Last refreshed: 16 May 2022
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