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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: Clinical Trial Phase 4 study, sponsored by University Hospitals Cleveland Medical Center.
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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change in left ventricular mass from baseline to 12 months.
Interventions
- DRUG Spironolactone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2018-07-17 |
| Est. Completion | 2020-07-31 |
| Phase | Phase 4 |
Why NCT03597035 stopped before completion
NCT03597035 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Spironolactone is the first listed.
NCT03597035 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03597035's enrollment target sits among peer trials
8 1972nd of 2000 higher than 20 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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