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Study probes heart and lung function in ME/CFS to unravel Post-Exertion crash

NCT ID NCT04740736

Knowledge-focused Sponsor: Icahn School of Medicine at Mount Sinai 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at heart and lung function in 106 people with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) to better understand post-exertional malaise—the severe worsening of symptoms after physical activity. Participants did two maximal exercise tests on consecutive days. Those with low blood volume on the first day received either a saline infusion or a sham infusion before the second test. The goal was to see how blood volume and exercise capacity relate to post-exertional malaise.

What this could mean

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

Active substance
Saline infusion
What this could lead to
If successful, this could help explain why ME/CFS patients feel worse after exertion and point toward better management strategies.
What could go wrong
This is a small, completed observational study, not a treatment trial. Results may not lead to new therapies or apply to all patients.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

106 people

The number who actually took part.

Started

Aug 2021

Finished

Jul 2025

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

25 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Ages 25 to 60 * Meet the 2015 IOM case definition for ME/CFS Exclusion Criteria: * Patients with a medical cause for their fatigue * Patients taking medications that would dampen cardiac response to exercise * Patients with psychotic illness, bipolar disorder, or current major depressive disorder * Patients with a history of anorexia or bulimia within 5 years of intake * Patients with a history of alcohol or drug abuse within 2 years of intake

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Conditions

The condition(s) this trial relates to.

myalgic encephalomeyelitis/chronic fatigue syndrome

As listed by the trial registrant

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

Chronic fatigue syndrome Myalgic encephalomyelitis

Contacts and locations

Locations

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

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