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Completed

NCT Number: NCT04740736

Cardiovascular Analysis of PEM

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.

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Key information

Conditions

Myalgic Encephalomyelitis Chronic Disease Chronic Fatigue Syndrome Disease Attributes Encephalomyelitis Fatigue Syndrome, Chronic Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saline Infusion

Procedure

Patient with hypovolemia on day 1 will be randomized to a saline or sham infusion prior to the Day 2 exercise test.

Primary outcomes

  1. CPET testing

    Time frame: 2 days

    To assess VO2VT and peak VO2

  2. Total Blood Volume

    Time frame: 2 days

    To measure Total Blood Volume (TBV) before each exercise test

  3. Hypovolemia

    Time frame: 1 day

    Patients with reduced Total Blood Volume on day #1 CPET will be randomized in a 1:1 fashion to either a one hour infusion of a liter of isotonic saline prior to day #2 CPET or a sham infusion

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

Cardiovascular Analysis of Post-exertional Malaise

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Feb 5, 2021
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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