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Should Low-Risk fainting patients stay overnight? new trial aims to find out

NCT ID NCT06472375

Knowledge-focused Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 looks at whether keeping low- and intermediate-risk fainting patients in the hospital for 24 hours with a heart monitor is better than sending them home right away. About 640 adults will be randomly assigned to either stay or go home. The goal is to see if the longer monitoring catches more heart rhythm problems that could be dangerous.

What this could mean

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

Active substance
24-hour heart monitor (Holter)
What this could lead to
If it works, this could show that 24-hour observation helps detect hidden heart rhythm problems in low-risk fainting patients, potentially improving care.
What could go wrong
This is an early-stage trial with 640 participants, so results may not apply to everyone. The benefit of extra monitoring might be small and not worth the hospital stay.

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.

Participants

About 640 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

Aug 2026

An estimate. End dates often move.

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.

Who is studied

Patients attending the Cardiac Emergency Room with low- and intermediate risk syncope.

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: All patients that are assessed as low- and intermediate risk syncope, are eligible for inclusion in this trial. The initial syncope evaluation includes: 1. Complete and thorough history taking of the syncope event and past medical history 2. Physical examination including supine and standing BP measurement and 3. 12 lead ECG. Exclusion Criteria: A potential patient who meets any of the following criteria will be excluded from participation in this study: 1. Those aged \<18 years 2. Those in whom syncope / transient loss of consciousness co-exist with trauma or other serious condition identified in the CER (massive bleeding, pulmonary embolus) or any high-risk features upon assessment with guideline based SA 3. Those with any other conditions then syncope / transient loss of consciousness for which admission is required (including social indication for admission, etc.) 4. Contraindication for early discharge as the discretion of the responsible physician 5. Those with a learning disability 6. Those presenting with pre-syncope 7. Those who are unwilling to provide informed consent (those will be asked to be enrolled for the SYNCOPE R.I.S.C-registry)

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Conditions

The condition(s) this trial relates to.

Syncope syncope, familial vasovagal

As listed by the trial registrant

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

Syncope

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Amsterdam UMC

    RECRUITING

    Amsterdam, 1105 AZ, Netherlands

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