TerminatedPhase 3

Metoprolol in Acute Respiratory Distress Syndrome (MAIDEN)

Stopped: Persistently low recruitment of subjects

Spain14 participantsStarted 2024-07-10

Plain-language summary

Randomised, double-blind, placebo-controlled clinical trial to evaluate the efficacy of intravenous metoprolol in patients with Acute Respiratory Respiratory Distress Syndrome (ARDS).

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 p…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial was terminated before completing — do you know why it was stopped early, and does that affect whether the results can tell us anything useful about using metoprolol for ARDS?
2Since this was a Phase 3 trial testing metoprolol in ARDS patients on mechanical ventilation, what does the existing evidence suggest about whether a beta-blocker like metoprolol could help or potentially harm someone in my situation?
3The trial measured 'days alive and free of mechanical ventilation' over 28 days — based on what was collected before the trial ended, is there any signal about whether metoprolol made a difference in how quickly patients came off the ventilator?
4Because this trial is no longer recruiting, are there other active trials or standard-of-care approaches for ARDS that you think would be a better path for me right now?
5Given that the trial was terminated, does that change how you'd think about metoprolol as part of my treatment plan, or is it something that might still be considered off-label in certain circumstances?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

days alive and free of invasive mechanical ventilation during the first 28 days.

Timeframe: 28 days

Trial details

NCT IDNCT05847517

SponsorConsorcio Centro de Investigación Biomédica en Red (CIBER)

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2025-10-06

View on ClinicalTrials.gov More Acute Respiratory Distress Syndrome (ARDS) trials

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.