Corticosteroids for Heart Failure

(CORTISHOCK-P Trial)

Overseen By Ameesh M Isath, MBBS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Brigham and Women's Hospital

Disqualifiers: Acute myocardial infarction, Sepsis, Kidney injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 30

Duration: 7 days

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Are You a Good Fit for This Trial?

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

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

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

How Is the Trial Designed?

Group I: Methylprednisolone plus Standard of Care Experimental Treatment 1 Intervention

Participants randomized to this intervention arm will receive standard of care (SoC) along with a short course of intravenous methylprednisolone. The methylprednisolone will be administered at a dose of 80 mg IV once daily for 3 days, followed by a taper of 0.5 mg/kg/day for 4 additional days, for a total of 7 days of therapy

Group II: Standard of Care (Control) Active Control 1 Intervention

Participants randomized to this control arm will receive current best practices and standard of care (SoC) alone for the management of SCAI Stage B or C cardiogenic shock. They will not receive the investigational methylprednisolone therapy

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+