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NCT03597035 · ClinicalTrials.gov registry record · Phase 4
Mineralocorticoid Receptor Antagonism Clinical Evaluation in Atherosclerosis Add-On
A Phase 4 study, sponsored by University Hospitals Cleveland Medical Center.
- Terminated
- Registry status
- Phase 4
- Development phase
- 8
- Enrollment target
NCT03597035 is a Phase 4 study that was terminated before completion, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 8 participants.
The verdict
NCT03597035, a Phase 4 study, was terminated before completion, sponsored by University Hospitals Cleveland Medical Center.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 8 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Spironolactone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2018-07-17 |
| Est. Completion | 2020-07-31 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03597035
The ClinicalTrials.gov registry entry for NCT03597035 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University Hospitals Cleveland Medical Center, which has 230 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Spironolactone is the first listed.
NCT03597035 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03597035 about?
NCT03597035 is a clinical study titled "Mineralocorticoid Receptor Antagonism Clinical Evaluation in Atherosclerosis Add-On". 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 hemodynami...
What is the current status of trial NCT03597035?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 8 participants. The study started on 2018-07-17. Estimated completion is 2020-07-31.
What interventions are being tested in trial NCT03597035?
The interventions under investigation include: Spironolactone (DRUG).
Who is sponsoring clinical trial NCT03597035?
This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.
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