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NCT07461961 · ClinicalTrials.gov registry record · Phase 2
CORTISHOCK-P: Trial of Corticosteroids in Inflammation-Enriched Heart Failure Cardiogenic Shock
A Phase 2 study, sponsored by Brigham and Women's Hospital.
- Not yet
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT07461961: Clinical Trial Phase 2 study, sponsored by Brigham and Women's Hospital.
NCT07461961 is a Phase 2 study that has not yet begun recruiting, run by Brigham and Women's Hospital. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07461961, a Phase 2 study, has not yet begun recruiting, sponsored by Brigham and Women's Hospital.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
This pilot study investigates whether giving a short course of intravenous corticosteroids (methylprednisolone) alongside standard medical care can help patients recovering from heart failure-related cardiogenic shock. Heart failure-related cardiogenic shock happens when chronic heart dysfunction causes poor blood circulation and congestion throughout the body. Often, this condition triggers severe inflammation, making it harder for the heart and other organs to recover, even when temporary mechanical heart pumps are used to support blood flow. The study aims to see if reducing this inflammation with corticosteroids is safe and can help patients get better faster. Researchers will enroll 30 adult patients hospitalized with early-stage (SCAI Stage B or C) cardiogenic shock related to heart failure. To participate, patients must also show high levels of inflammation in their blood, specifically a high-sensitivity C-reactive protein (hsCRP) level of 20 mg/L or higher Participants will be randomly assigned by chance to one of two groups. One group will receive the standard of care alone. The other group will receive the standard of care plus a 7-day course of intravenous methylprednisolone. The main goal of the study is to measure the change in inflammation levels (hsCRP) over 7 days. Researchers will also monitor how well the patients' organs recover, track their need for blood pressure medications or mechanical heart pumps, and monitor for any side effects to ensure the treatment is safe
Primary Outcome
The primary outcome is the change in hsCRP concentration, which serves as a biomarker-based measure of systemic inflammation to evaluate corticosteroid-mediated inflammatory modulation. To account for the pharmacokinetics of methylprednisolone, a 12-hour blanking period will be imposed; clinical outcomes occurring within the first 12 hours after treatment initiation will not be considered in the analysis
Interventions
- OTHER Standard of Care (SOC)
- DRUG Methylprednisone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2026-07-01 |
| Est. Completion | 2029-02-01 |
| Phase | Phase 2 |
What is known before NCT07461961 opens enrollment
NCT07461961 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard of Care (SOC) is the first listed.
NCT07461961 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07461961 about?
NCT07461961 is a clinical study titled "CORTISHOCK-P: Trial of Corticosteroids in Inflammation-Enriched Heart Failure Cardiogenic Shock". This pilot study investigates whether giving a short course of intravenous corticosteroids (methylprednisolone) alongside standard medical care can help patients recovering from heart failure-related cardiogenic shock. Heart failure-related cardiogenic shock happens when chronic heart dysfunction ca...
What is the current status of trial NCT07461961?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2026-07-01. Estimated completion is 2029-02-01.
What interventions are being tested in trial NCT07461961?
The interventions under investigation include: Standard of Care (SOC) (OTHER), Methylprednisone (DRUG).
Who is sponsoring clinical trial NCT07461961?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07461961's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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