CompletedNot Applicable

Cardiovascular Analysis of PEM

United States106 participantsStarted 2021-08-31

Plain-language summary

The purpose of this study is to examine cardiopulmonary function in Chronic Fatigue Syndrome (CFS) patients and determine how it relates to the common symptom of Post-exertional malaise (PEM). Subjects will complete a maximal exercise test on 2 subsequent days. Total blood volume will be measured prior to each exercise test, and patient with hypovolemia on day 1, will be randomized to either a saline or sham infusion prior to the 2nd exercise test. A total of 80 CFS patients will be enrolled.

Who can participate

Age range25 Years – 60 Years

SexALL

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

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

What they're measuring

CPET testing

Timeframe: 2 days

Total Blood Volume

Timeframe: 2 days

Hypovolemia

Timeframe: 1 day

Trial details

NCT IDNCT04740736

SponsorIcahn School of Medicine at Mount Sinai

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-11

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