Corticosteroids for Heart Failure

(CORTISHOCK-P Trial)

AM
Overseen ByAmeesh M Isath, MBBS
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Brigham and Women's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding a short course of intravenous corticosteroids (a type of anti-inflammatory medicine) to the standard treatment for patients recovering from heart failure-related cardiogenic shock can reduce inflammation and speed up recovery. Cardiogenic shock occurs when the heart can't pump enough blood, leading to poor circulation and inflammation, which can hinder recovery. The study compares two groups: one receiving only standard care and another receiving standard care plus the corticosteroid treatment, specifically methylprednisolone. It seeks patients hospitalized with this condition who have high inflammation levels in their blood. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people, offering a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that methylprednisolone is likely to be safe for humans?

Research has shown that methylprednisolone, a type of steroid, is generally safe in medical settings. Studies have found that high doses over 100 mg can improve survival rates in hospital patients. Additionally, steroids are considered safe for people recovering from heart attacks, with no significant increase in short-term death risks.

However, some studies noted higher death rates over 90 days in certain groups using steroids, suggesting the need to carefully consider individual patient factors. Importantly, some trials reported no major side effects, even with higher doses.

Overall, methylprednisolone appears well-tolerated, but like any medication, it carries risks, so monitoring remains important.12345

Why do researchers think this study treatment might be promising?

Most treatments for heart failure typically involve medications like ACE inhibitors, beta-blockers, and diuretics, which help manage symptoms and improve heart function over time. Unlike these standard treatments, methylprednisolone is a corticosteroid that works by reducing inflammation quickly. Researchers are excited about methylprednisolone because it can potentially show significant effects in just a few days, offering rapid relief in addition to standard care. This fast-acting nature could be especially beneficial in acute situations like cardiogenic shock, where time is critical.

What evidence suggests that methylprednisolone might be an effective treatment for heart failure-related cardiogenic shock?

Research has shown that methylprednisolone, a type of steroid, might help people with heart failure by reducing inflammation. Studies have found that high doses of this steroid can lead to better survival rates and improved heart function. Specifically, one study discovered that methylprednisolone helps the heart use oxygen more efficiently, aiding recovery. It has also been linked to more effective heart pumping. However, some research has indicated that using steroids can increase the risk of death, so caution is necessary. In this trial, participants in one arm will receive methylprednisolone alongside standard care, while those in the control arm will receive standard care alone. Overall, while potential benefits exist, results have been mixed, and more research is needed.12678

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 in the ICU with early-stage heart failure-related cardiogenic shock, high inflammation (hsCRP ≥20 mg/L), and poor blood flow. People can't join if they have other causes of shock, severe organ failure, recent heart transplant or LVAD plans, are pregnant/breastfeeding, or have certain serious infections.

Inclusion Criteria

Hypotension defined by SBP <90 mmHg for >30 min, MAP <60 mmHg for >30 min, or requirement of vasopressors to maintain SBP ≥90 mmHg or MAP ≥60 mm Hg
For SCAI Stage B, hypotension SBP <90 mmHg or MAP <60 mmHg or >30 mmHg drop from baseline, or tachycardia heart rate ≥100 bpm
For SCAI Stage C, NONE of the following criteria of deterioration from admission until randomization
See 14 more

Exclusion Criteria

Cardiac transplant patient or on the transplant list
Patient planned for implantation of a durable LVAD
Moribund patients (SAPS2 >90) or predicated mortality >90% within 30 days
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 days

Treatment

Participants receive either standard of care alone or standard of care plus a 7-day course of intravenous methylprednisolone

7 days
Daily in-person visits for clinical and laboratory assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment, including remote follow-up at 30 days post-discharge

30 days
Remote follow-up at 30 days post-discharge

What Are the Treatments Tested in This Trial?

Interventions

  • Methylprednisolone

Trial Overview

The study compares standard care alone versus standard care plus a short course (7 days) of intravenous methylprednisolone (a corticosteroid) to see if lowering inflammation helps recovery in patients with heart failure-related cardiogenic shock. Patients are randomly assigned to each group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Methylprednisolone plus Standard of CareExperimental Treatment1 Intervention
Group II: Standard of Care (Control)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials
1,694
Recruited
14,790,000+

Citations

Corticosteroids in Cardiogenic Shock: A Retrospective ... - PMC

Corticosteroid use was associated with increased 90-day mortality in multivariate analysis (hazard ratio, 1.60; 95% CI, 1.25–2.05) and fewer VFDs (2.8 d fewer; ...

Efficacy and safety of corticosteroid therapy in patients with ...

High-dose corticosteroid treatment (above 100 mg methylprednisolone) is associated with better overall survival rate at hospital discharge and ROSC outcomes.

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39888591/

Corticosteroids in Cardiogenic Shock: A Retrospective ...

Corticosteroid use was associated with increased 90-day mortality in multivariate analysis (hazard ratio, 1.60; 95% CI, 1.25-2.05) and fewer ...

Effects of methylprednisolone administration in acute ...

Methylprednisolone was thought to improve the critical oxygen balance of the infarcted heart by two mechanisms: (1) by diminishing heart rate, afterload and ...

Steroids Used In Cardiogenic Shock

lated to their use. Although pacing produced an av¬ erage increase of 30% in cardiac in¬ dexes, the actual results varied from negligible to ...

Use of Methylprednisolone in Patients following Acute ...

Following the administration of methylprednisolone, significant increases in cardiac output and consequent decreases in systemic vascular resistance were ...

Efficacy and safety of corticosteroids in cardiac arrest - PMC

Corticosteroids probably increase return of spontaneous circulation (ROSC) (RR 1.32, 95% CI 1.18–1.47, moderate certainty) and may increase the likelihood of ...

The effect of methylprednisolone treatment ... - Oxford Academic

The results indicate that a single low-dose of methylprednisolone (10mg/kg) reduces the inflammatory reaction during and after CPB.