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Heart drug fails to prove benefit for lung failure patients in early-stop trial

NCT ID NCT05847517

Disease control Sponsor: Consorcio Centro de Investigación Biomédica en Red (CIBER) 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether giving the heart medication metoprolol through a vein could help people with severe lung failure (ARDS) in the ICU. The goal was to see if it helped them breathe without a machine for more days. However, the trial was stopped early and only 14 people took part, so no clear conclusions can be drawn.

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

14 people

The number who actually took part.

Started

Jul 2024

Finished

Oct 2025

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

18 to 80 years

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: * Patients (≥18 years and \<80 years) with a clinical diagnosis of ARDS of any aetiology (pneumonia, including SARS-CoV-2, sepsis, pancreatitis, bronchospasm and trauma) admitted to the ICU. * Orotracheal intubation (OTI) and mechanical ventilation within 72 hours prior to randomisation. * Moderate-severe ARDS (PaO2/FiO2: ≤200 mmHg under standardised conditions (PEEP≥5 cm H2O). * Heart rate ≥ 60 bpm. * Invasive systolic blood pressure ≥ 110 mmHg. Exclusion Criteria: * Prolonged hospital admission prior to randomisation (i.e. ≥7 days at the time of randomisation). * Reduced left ventricular ejection fraction (LVEF \<50%). * Life expectancy due to other processes (cancer, degenerative diseases, etc.) of less than 6 months. * Right ventricular (RV) systolic dysfunction. * Concomitant acute heart failure (cardiac index ≤2.5 L/m2 or pulmonary capillary pressure ≥15 mmHg or clinical suspicion). * Second-degree atrioventricular (AV) block, 2:1 AV block, high-grade/advanced AV block and third-degree AV block. Also significant sinus bradycardia, which would be implied by having a heart rate \>60 bpm as an inclusion criterion. * Pregnant or breastfeeding women. * Cardiogenic shock. * Persistent invasive blood pressure \<110 mmHg despite vasopressor agents. * Use of noradrenaline at concentrations greater than 0.2 µg/kg/min at the time of the randomisation. * Use of dobutamine within 48 hours before randomisation. * Concomitant pulmonary embolism. * Known severe peripheral arterial disease. * Known asthma before admission (with active bronchodilator therapy). * Active beta-blocker treatment prior to admission (i.e. within 3 months prior to admission).

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Conditions

The condition(s) this trial relates to.

acute respiratory distress syndrome adult acute respiratory distress syndrome Drug-Related Side Effects and Adverse Reactions pancreatitis Pathologic Processes pneumonia Respiration Disorders Sepsis

As listed by the trial registrant

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

Acute respiratory distress syndrome (ARDS)

Contacts and locations

Locations

  • Complejo Hospitalario Universitario de Toledo

    Toledo, Castille-La Mancha, 45007, Spain

  • Consorci Corporació Sanitària Parc Taulí

    Barcelona, Catalonia, 08208, Spain

  • Hospital Clínic de Barcelona

    Barcelona, Catalonia, 08036, Spain

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011, Spain

  • Hospital Universitario Clínico San Carlos

    Madrid, 28040, Spain

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040, Spain

  • Hospital Universitario General de Villalba

    Madrid, 28400, Spain

  • Hospital Universitario Jerez de la Frontera

    Jerez de la Frontera, Cádiz, 11407, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Rey Juan Carlos

    Madrid, 28933, Spain

  • Hospital Universitario de Getafe

    Madrid, 28905, Spain

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