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Could cheap steroids help hearts in shock?

NCT ID NCT03773822

Disease control Sponsor: CMC Ambroise Paré Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether giving low doses of two steroids (hydrocortisone and fludrocortisone) helps adults with cardiogenic shock, a life-threatening condition where the heart can't pump enough blood. 380 participants received either the steroids or a placebo. The main goal was to see if the steroids increased the number of days patients could go without blood pressure support medications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
hydrocortisone and fludrocortisone (low-dose steroids)
What this could lead to
If it works, this could offer a simple, low-cost way to help people in cardiogenic shock recover faster and need less intensive support.
What could go wrong
This is a completed phase 3 trial, but results may not apply to all patients. Steroids can have side effects, and the benefit may be modest or absent.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

380 people

The number who actually took part.

Started

Apr 2019

Finished

Apr 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Aged ≥18 years 2. Cardiogenic shock state, according to the consensual definition: 1. Systemic arterial hypertension (systolic blood pressure \<90 mmHg or mean arterial pressure ≤ 65 mmHg) or signs of peripheral hypoperfusion, requiring treatment with catecholamines to maintain systolic blood pressure ≥ 90 mmHg and regression of signs of hypoperfusion; 2. Presence of at least one sign of systemic hypoperfusion among the following: marbling, oliguria ≤ 25 ml / h, impairment of consciousness, arterial hyperlactatemia\> 2 mmol / L; 3. Presence of at least one sign of hypocontractility or low flow among the following: cardiac index ≤ 2.2 L / min / m2, left ventricular ejection fraction (LVEF) ≤ 40% or full time velocity (ITV) under aortic ≤ 18 cm, or need for catecholamines to maintain an index 4. Clinical signs of left and / or right cardiac congestion (clinical sign of acute cardiogenic pulmonary edema or jugular turgor or edema of the lower limbs), radiological (bilateral alveolar opacities compatible with acute cardiogenic pulmonary edema), echocardiography (elevation of filling pressures of the left ventricle measured with Doppler: E / A\> 2 if LVEF ≤40% or E / Ea\> 13 if LVEF\> 40%; or estimated PAPS\> 35mmHg) or with right cardiac catheterization (pulmonary artery occlusion pressures\> 15mmHg or PAPm\> 25mmHg) 3. Having received informed information about the study and having signed a consent to participate in the study 4. Benefiting from a social security Exclusion Criteria: 1. Cardiogenic shock state with catecholamine infusion for more than 24 hours; 2. Presence Presence of septic shock at inclusion; 3. Cardiopulmonary arrest recovered in the 7 days preceding inclusion with at least one early sign of poor prognosis among the following: no control, non-shockable rhythm, CAHP score (Cardiac Arrest Hospital Prognosis)\> 150; 4. Patients already on circulatory support (ECMO) before inclusion (patients who are assisted after inclusion will not be excluded); 5. Cardiogenic shock on viral myocarditis; 6. Prior corticosteroid therapy (≥ 30 mg prednisone or equivalent ≥ 1 month); 7. Receiving one of the following treatments: ketoconazole, rifampicin, phenytoin, phenobarbital, cyclosporine and clarithromycin; 8. Known history of hypersensitivity to fludrocortisone or hydrocortisone; 9. Known pregnancy or breastfeeding;

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Conditions

The condition(s) this trial relates to.

adrenocortical insufficiency cardiogenic shock Shock, Cardiogenic

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiogenic shock

Contacts and locations

Locations

  • CH Intercommunal de Villeneuve Saint Georges

    Villeneuve-Saint-Georges, Villeneuve Saint Georges, 94190, France

  • CH Pontoise

    Pontoise, 95300, France

  • CH de Marne la Vallée - Site Jossigny

    Jossigny, Jossigny, 77600, France

  • CHRU Hôpitaux de Tours

    Tours, 37000, France

  • CHU Lille - Institut Cœur Poumon

    Lille, 59000, France

  • CHU de Nîmes

    Nîmes, 30029, France

  • CHU de Strasbourg

    Strasbourg, Strasbourg, 67000, France

  • CMC Ambroise Paré

    Neuilly-sur-Seine, 92200, France

  • Centre Hospitalier Saint Joseph Saint Luc

    Lyon, 69007, France

  • Centre cardiologique du nord saint denis

    Saint-Denis, 93200, France

  • Groupe Hospitalier Paris Saint Joseph

    Paris, 75014, France

  • Hopital Rangueil

    Toulouse, 31400, France

  • Hôpital Ambroise Paré

    Boulogne-Billancourt, Boulogne-Billancourt, 92100, France

  • Hôpital Arnaud-de-Villeneuve

    Montpellier, 34090, France

  • Hôpital Bichat

    Paris, 75018, France

  • Hôpital Cochin

    Paris, 75014, France

  • Hôpital Henri Mondor

    Paris, Île-de-France Region, France

  • Hôpital Parly II

    Le Chesnay, Le Chasnay, 78150, France

  • Hôpital Privé Jacques Cartier

    Massy, Massy, 91300, France

  • Hôpital européen Georges-Pompidou

    Paris, 75015, France

  • Hôpitaux Universitaires Pitié Salpêtrière

    Paris, 75013, France

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