Cardiogenic ShockPhase 2CORTISHOCK-PNCT07461961
CORTISHOCK-P: Trial of Corticosteroids in Inflammation-Enriched Heart Failure Cardiogenic Shock
A Phase 2 study testing Methylprednisone in people with Cardiogenic Shock and Heart Failure, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiogenic Shock, Heart Failure, Inflammation
- What is being tested?
- Methylprednisone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 1 Feb 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and ≤ 80 years.
- Hospitalized in the Intensive Care Unit (ICU).
- Cardiogenic shock defined by clinical and hemodynamic 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.
- Hypoperfusion defined by altered mental state, cold extremities, livedo reticularis, urine output <30 mL/h, or lactate ≥2 mmol/L.
- If invasive hemodynamic monitoring is available, CI <2.2 L/min/m2.
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- SCAI stage B or stage C at the time of screening.
- For SCAI Stage B (Beginning Shock), clinical evidence of hemodynamic instability (including relative hypotension, a decline in SBP of ≥20-30 mmHg, or MAP <20% from baseline, or tachycardia) without hypoperfusion (normal lactate).
- 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, requiring only one vasoactive/inotrope and/or IABP from admission with CS until randomization, AND Vasoactive-inotropic score (VIS) <40.
- For SCAI Stage C, NONE of the following criteria of deterioration from admission until randomization: failure to respond to initial single vasopressor/inotrope drug and addition of a second drug, or failure to respond to IABP and need for new MCS device.
- For SCAI Stage C, use of vasoactive agents at the time of randomization must not show: low starting dose with escalation, intermediate starting dose without escalation or de-escalation, or high starting dose with de-escalation.
- For SCAI Stage C, worst lactate 2 - 5 mmol/L and increase ≥ 100% from baseline lactate ≥ 2mmol/L or worst lactate ≥5mmol/L.
- Documented history of chronic heart failure with reduced ejection fraction (LVEF <40%).
- Etiology of cardiogenic shock must be congestive heart failure decompensation (HF-CS).
- hsCRP ≥20 mg/L, reflecting a pro-inflammatory state.
- Less than 48 hours since admission
Who cannot join
- Cardiogenic shock caused by acute myocardial infarction (AMI-CS).
- Other special conditions causing cardiogenic shock, including post-cardiotomy CS, peripartum, adrenergic, valvular, restrictive, post-embolic, conduction or rhythm disorders, or related to cardiotropic drug intoxication.
- Circulatory shock of another cause, such as septic, hemorrhagic, or anaphylactic shock.
- Shock post-cardiac arrest.
- Onset of cardiogenic shock >48 hours.
- SCAI stage A, D, or E at the time of enrollment.
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- Severe hyperglycemia at baseline, defined as blood glucose ≥300 mg/dL despite insulin therapy.
- Ongoing uncontrollable infection, suspected concomitant sepsis, or mixed septic-cardiogenic shock.
- Ischemic hepatitis or ALT >500 IU/L due to causes other than suspected hypoperfusion.
- Severe refractory acute kidney injury (AKI) at baseline, defined as new persistent anuria (urine output <50 mL/day) or refractory AKI requiring new emergent renal replacement therapy.
- Known allergy to methylprednisolone or other steroid analogues.
- 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.
- Signs of extremis, including lactate >5 mmol/L, pH <7.2, or refractory shock requiring escalation to >3 vasopressors at screening.
- Pregnant woman, parturient, or breastfeeding mother.
- Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Brigham and women's hospital
Boston, Massachusetts, 02446
Ameesh M Isath, MBBS, 617-525-7053, aisath@bwh.harvard.edu
About this study
Official title: CORTISHOCK-P: A Randomized Pilot Trial of Corticosteroids as a Pharmacologic Adjunct to Temporary Mechanical Circulatory Support 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 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
Read more
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
Read the detailed description
Heart failure-related cardiogenic shock (HF-CS) is currently the most common form of shock in contemporary cardiac intensive care units. While temporary mechanical circulatory support (tMCS) devices effectively restore cardiac output and stabilize central hemodynamics, patient outcomes remain poor, with mortality approaching 40-50%. A major barrier to recovery in these patients is systemic inflammation and immune dysregulation. This creates a state of "hemodynamic dissonance," where central hemodynamics are restored but peripheral circulatory failure and end-organ dysfunction persist. This condition is further exacerbated by critical illness-related corticosteroid insufficiency (CIRCI), present in up to 50% of cardiogenic shock patients, as well as the inflammatory response triggered by the extracorporeal circuits themselves.
The CORTISHOCK-P trial is a prospective, randomized, open-label pilot study designed to test whether a short course of intravenous corticosteroids can effectively attenuate this systemic inflammatory storm. By specifically targeting patients with an inflammation-enriched phenotype (high-sensitivity C-reactive protein [hsCRP] ≥ 20 mg/L), this study introduces a biologically targeted pharmacological adjunct to complement tMCS and standard of care (SoC).
The study will enroll 30 adult patients admitted to the intensive care units at Brigham and Women's Hospital and Massachusetts General Hospital. Eligible patients will have SCAI Stage B or C HF-CS and a left ventricular ejection fraction of <40%. Following informed consent, participants will be randomized in a 1:1 ratio within 24 hours of admission to receive either standard of care alone or standard of care plus intravenous methylprednisolone. The pharmacological intervention consists of methylprednisolone administered at 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 duration of 7 days. Methylprednisolone was selected for its potent anti-inflammatory properties and lower mineralocorticoid activity, minimizing fluid retention while maximizing inflammatory suppression.
The primary objective is to evaluate the anti-inflammatory effects of the intervention, measured by the change in hsCRP concentrations from baseline to Day 7.
Secondary objectives focus on clinical trajectories and resource utilization, including:
Characterizing the impact of corticosteroids on circulatory support requirements, including vasoactive inotropic score (VIS) trends, as well as the escalation and weaning of tMCS devices.
Determining the effects on organ dysfunction, specifically evaluating renal and hepatic dysfunction, as well as hemolysis indices.
Assessing the overall feasibility, protocol adherence, and safety of administering corticosteroid therapy in this critically ill population.
Safety will be continuously monitored, with specific attention given to adverse events such as hyperglycemia with ketoacidosis, new severe infections, gastrointestinal bleeding, and thromboembolic events. Clinical and laboratory assessments will be conducted daily from randomization through Day 7 or ICU discharge, with remote follow-up at 30 days post-discharge. Given the small sample size, statistical analyses will primarily focus on estimating effect sizes and precision to establish proof-of-concept and lay the groundwork for a definitive multicenter trial.
- Conditions
- Cardiogenic Shock, Heart Failure, Inflammation
- Being tested
- Methylprednisone, Standard of Care (SOC)
- Keywords
- cardiogenic shock, heart failure cardiogenic shock, inflammation, corticosteroids
- Medical subject headings
- Shock, Cardiogenic, Heart Failure, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylprednisoneDrug
Intravenous methylprednisolone administered as an adjunctive therapy to target systemic inflammation. The dosing regimen is 80 mg IV once daily for 3 days, followed by a taper of 0.5 mg/kg/day for 4 additional days (total of 7 days). This regimen aims to provide potent early anti-inflammatory effects while minimizing fluid retention and adverse events
Standard of Care (SOC)Other
Routine medical care and management for heart failure-related cardiogenic shock, which may include vasoactive medications and temporary mechanical circulatory support (tMCS) per institutional protocols.
| Study group | Role | What they receive |
|---|---|---|
| Methylprednisolone plus Standard of Care | Experimental | 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 Receives: Drug: Methylprednisone |
| Standard of Care (Control) | Active comparator | 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 Receives: Other: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in High-Sensitivity C-Reactive Protein (hsCRP) Concentration
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
Measured: Baseline, 24, 48, 72, and 96 hours, and at day 7 or ICU discharge
Secondary outcomes (7)
Change in Interleukin-6 (IL-6) Concentration
Serial measurements of key inflammatory biomarkers, including IL-6, will be performed to assess the mechanistic impact of corticosteroid therapy on inflammation.
Measured: Baseline, 24, 48, 72, and 96 hours, and at day 7 or ICU discharge
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) and High-sensitivity troponin T (hs-TnT)Concentration
Serial measurements of NT-proBNP and hs-TnT will be performed to assess cardiac biomarker trajectories
Measured: Baseline, 24, 48, 72, and 96 hours, and at day 7 or ICU discharge
Temporal Trends in Vasoactive Inotropic Score (VIS)
The VIS will be analyzed to assess hemodynamic recovery and the requirement for vasoactive support. The peak VIS, duration of high-dose vasoactive support, and sustained high-dose vasoactive requirement (VIS ≥40 or an increase of ≥10 points from baseline sustained for ≥6 hours) will be recorded
Measured: Baseline, 24, 48, 72, and 96 hours, and at day 7 or ICU discharge
Escalation of Device Therapy
Escalation of device therapy is defined as progression from an intra-aortic balloon pump (IABP) to a microaxial flow pump or venoarterial extracorporeal membrane oxygenation (VA-ECMO). The type of device, timing of escalation, and duration of support will be recorded
Measured: Through study completion, an average of 30 days
Successful Device Weaning
Successful device weaning is defined as the removal of temporary mechanical circulatory support (tMCS) without the recurrence of hemodynamic instability within 48 hours.
Measured: Through study completion, an average of 30 days
Lactate Clearance
Lactate clearance is defined as the relative reduction in serum lactate levels compared to baseline. Persistent hyperlactatemia (lactate ≥3.0 mmol/L) or failure to achieve >50% lactate clearance at 24 hours will be analyzed as markers of impaired metabolic recovery and tissue hypoperfusion
Measured: 6, 12, 24, and 48 hours
Incidence of Adverse Events and Safety Outcomes
The safety of adjunctive methylprednisolone therapy will be monitored to identify adverse events associated with corticosteroid use and complications in critically ill patients. This includes monitoring for hyperglycemia resulting in ketoacidosis, serious infections, gastrointestinal complications, and thromboembolic events
Measured: through study completion, an average of 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Thirty adult patients with SCAI Stage B or C HF-CS and LVEF \<40% will be randomized in a 1:1 ratio within 24 hours of admission to receive either standard of care (SoC) or SoC plus a short course of intravenous methylprednisolone. The randomization uses an adaptive restricted procedure ("biased coin design") to balance group assignments
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ameesh Isath, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07461961
- Sponsor's protocol ID
- 2025P002774
- Acronym
- CORTISHOCK-P
- Status last verified
- Aug 2026
- First submitted
- 23 Feb 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: There are no immediate plans to share or transfer study data or biospecimens to external collaborators. All information obtained for this protocol will remain within Mass General Brigham (MGB) for storage, analysis, and publication of aggregate findings.
Publications
Isath A, Desai AS, Mehra MR. Beyond the Pump: Reframing Cardiogenic Shock in Heart Failure Through a Multisystem Mechanistic Lens. JACC Heart Fail. 2026 Jan;14(1):102711. doi: 10.1016/j.jchf.2025.102711. Epub 2025 Oct 16.
PubMed 41099686
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CORTISHOCK-P: A Randomized Pilot Trial of Corticosteroids as a Pharmacologic Adjunct to Temporary Mechanical Circulatory Support in Inflammation-Enriched Heart Failure Cardiogenic Shock
- ClinicalTrials.gov ID
- NCT07461961
- Acronym / sponsor ID
- CORTISHOCK-P / 2025P002774
- Conditions
- Cardiogenic Shock, Heart Failure, Inflammation
- Keywords
- cardiogenic shock, heart failure cardiogenic shock, inflammation, corticosteroids
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Heart failure-related cardiogenic shock (HF-CS) is currently the most common form of shock in contemporary cardiac intensive care units. While temporary mechanical circulatory support (tMCS) devices effectively restore cardiac output and stabilize central hemodynamics, patient outcomes remain poor, with mortality approaching 40-50%. A major barrier to recovery in these patients is systemic inflammation and immune dysregulation. This creates a state of "hemodynamic dissonance," where central hemodynamics are restored but peripheral circulatory failure and end-organ dysfunction persist. This condition is further exacerbated by critical illness-related corticosteroid insufficiency (CIRCI), present in up to 50% of cardiogenic shock patients, as well as the inflammatory response triggered by the extracorporeal circuits themselves.
The CORTISHOCK-P trial is a prospective, randomized, open-label pilot study designed to test whether a short course of intravenous corticosteroids can effectively attenuate this systemic inflammatory storm. By specifically targeting patients with an inflammation-enriched phenotype (high-sensitivity C-reactive protein [hsCRP] ≥ 20 mg/L), this study introduces a biologically targeted pharmacological adjunct to complement tMCS and standard of care (SoC).
The study will enroll 30 adult patients admitted to the intensive care units at Brigham and Women's Hospital and Massachusetts General Hospital. Eligible patients will have SCAI Stage B or C HF-CS and a left ventricular ejection fraction of <40%. Following informed consent, participants will be randomized in a 1:1 ratio within 24 hours of admission to receive either standard of care alone or standard of care plus intravenous methylprednisolone. The pharmacological intervention consists of methylprednisolone administered at 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 duration of 7 days. Methylprednisolone was selected for its potent anti-inflammatory properties and lower mineralocorticoid activity, minimizing fluid retention while maximizing inflammatory suppression.
The primary objective is to evaluate the anti-inflammatory effects of the intervention, measured by the change in hsCRP concentrations from baseline to Day 7.
Secondary objectives focus on clinical trajectories and resource utilization, including:
Characterizing the impact of corticosteroids on circulatory support requirements, including vasoactive inotropic score (VIS) trends, as well as the escalation and weaning of tMCS devices.
Determining the effects on organ dysfunction, specifically evaluating renal and hepatic dysfunction, as well as hemolysis indices.
Assessing the overall feasibility, protocol adherence, and safety of administering corticosteroid therapy in this critically ill population.
Safety will be continuously monitored, with specific attention given to adverse events such as hyperglycemia with ketoacidosis, new severe infections, gastrointestinal bleeding, and thromboembolic events. Clinical and laboratory assessments will be conducted daily from randomization through Day 7 or ICU discharge, with remote follow-up at 30 days post-discharge. Given the small sample size, statistical analyses will primarily focus on estimating effect sizes and precision to establish proof-of-concept and lay the groundwork for a definitive multicenter trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Thirty adult patients with SCAI Stage B or C HF-CS and LVEF <40% will be randomized in a 1:1 ratio within 24 hours of admission to receive either standard of care (SoC) or SoC plus a short course of intravenous methylprednisolone. The randomization uses an adaptive restricted procedure ("biased coin design") to balance group assignments
| Arm | Type | Receives |
|---|---|---|
| Methylprednisolone plus Standard of Care | Experimental | Drug: MethylprednisoneParticipants 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 |
| Standard of Care (Control) | Active comparator | Other: Standard of Care (SOC)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 may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age ≥ 18 and ≤ 80 years.
- Hospitalized in the Intensive Care Unit (ICU).
- Cardiogenic shock defined by clinical and hemodynamic 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.
- Hypoperfusion defined by altered mental state, cold extremities, livedo reticularis, urine output <30 mL/h, or lactate ≥2 mmol/L.
Key exclusion criteria (17 listed)
- Cardiogenic shock caused by acute myocardial infarction (AMI-CS).
- Other special conditions causing cardiogenic shock, including post-cardiotomy CS, peripartum, adrenergic, valvular, restrictive, post-embolic, conduction or rhythm disorders, or related to cardiotropic drug intoxication.
- Circulatory shock of another cause, such as septic, hemorrhagic, or anaphylactic shock.
- Shock post-cardiac arrest.
- Onset of cardiogenic shock >48 hours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethylprednisoneIntravenous methylprednisolone administered as an adjunctive therapy to target systemic inflammation. The dosing regimen is 80 mg IV once daily for 3 days, followed by a taper of 0.5 mg/kg/day for 4 additional days (total of 7 days). This regimen aims to provide potent early anti-inflammatory effects while minimizing fluid retention and adverse events | Drug | Methylprednisolone plus Standard of Care |
| Standard of Care (SOC)Routine medical care and management for heart failure-related cardiogenic shock, which may include vasoactive medications and temporary mechanical circulatory support (tMCS) per institutional protocols. | Other | Standard of Care (Control) |
Primary outcome
Change in High-Sensitivity C-Reactive Protein (hsCRP) Concentration
Time frame: Baseline, 24, 48, 72, and 96 hours, and at day 7 or ICU discharge
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
7 secondary outcomes
Change in Interleukin-6 (IL-6) Concentration
Time frame: Baseline, 24, 48, 72, and 96 hours, and at day 7 or ICU discharge
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) and High-sensitivity troponin T (hs-TnT)Concentration
Time frame: Baseline, 24, 48, 72, and 96 hours, and at day 7 or ICU discharge
Temporal Trends in Vasoactive Inotropic Score (VIS)
Time frame: Baseline, 24, 48, 72, and 96 hours, and at day 7 or ICU discharge
Escalation of Device Therapy
Time frame: Through study completion, an average of 30 days
Successful Device Weaning
Time frame: Through study completion, an average of 30 days
Lactate Clearance
Time frame: 6, 12, 24, and 48 hours
Incidence of Adverse Events and Safety Outcomes
Time frame: through study completion, an average of 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Background: PubMed 41099686Isath A, Desai AS, Mehra MR. Beyond the Pump: Reframing Cardiogenic Shock in Heart Failure Through a Multisystem Mechanistic Lens. JACC Heart Fail. 2026 Jan;14(1):102711. doi: 10.1016/j.jchf.2025.102711. Epub 2025 Oct 16.
- Individual participant dataSharing planned: Undecided. There are no immediate plans to share or transfer study data or biospecimens to external collaborators. All information obtained for this protocol will remain within Mass General Brigham (MGB) for storage, analysis, and publication of aggregate findings.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Methylprednisone in people with Cardiogenic Shock and Heart Failure, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ameesh M Isath, MBBS (617-525-7053, aisath@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in High-Sensitivity C-Reactive Protein (hsCRP) Concentration (time frame: Baseline, 24, 48, 72, and 96 hours, and at day 7 or ICU discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07461961, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.