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Standard of Care (SOC) / Methylprednisone / Heart Failure · Phase 2 Trial
ClinicalTrials.gov · August 13, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a planned Phase 2 pilot randomized trial evaluating intravenous methylprednisolone plus standard care versus standard care alone in 30 hospitalized patients with inflammation-enriched cardiogenic shock secondary to heart failure. The trial has not yet begun recruitment and no results are reported; it aims to measure safety and changes in the inflammatory biomarker hsCRP over 7 days.
Phase 2, Interventional, Randomized, Parallel, Open label, Treatment purpose. Cardiogenic Shock, Heart Failure, Inflammation; age from 18 Years; to 80 Years. Intervention: Methylprednisolone plus Standard of Care. Compared with: Standard of Care (Control) — Active Comparator. n = 30. 1 site: United States.
This is a planned Phase 2 pilot randomized trial evaluating intravenous methylprednisolone plus standard care versus standard care alone in 30 hospitalized patients with inflammation-enriched cardiogenic shock secondary to heart failure. The trial has not yet begun recruitment and no results are reported; it aims to measure safety and changes in the inflammatory biomarker hsCRP over 7 days.
Primary endpoint is a biomarker (hsCRP), not a hard clinical outcome (mortality, organ function recovery, or mechanical support duration). Sample size (n=30) is insufficient to detect clinical benefit; pilot phase designed for feasibility and safety only.
Clinicians should monitor this pilot for safety and biomarker signals; results, when available, will inform whether a larger trial on clinical outcomes in inflammation-enriched cardiogenic shock is warranted.
This is a Phase 2 pilot study not yet recruiting with a planned sample of 30 patients and a surrogate primary endpoint (hsCRP); no results are posted in this registry record.
As stated by the source record.
Quoted from the source exactly as published.
Clinicians should monitor this pilot for safety and biomarker signals; results, when available, will inform whether a larger trial on clinical outcomes in inflammation-enriched cardiogenic shock is warranted.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07461961). This is a study registration, not published results. Lead sponsor: Brigham and Women's Hospital. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 30 participants (ESTIMATED). Conditions: Cardiogenic Shock, Heart Failure, Inflammation. Interventions: DRUG: Methylprednisone; OTHER: Standard of Care (SOC). Primary outcome measures: Change in High-Sensitivity C-Reactive Protein (hsCRP) Concentration , Baseline, 24, 48, 72, and 96 hours, and at day 7 or ICU discharge. Brief 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
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