Cardiovascular Analysis of PEM

NCT04740736 | Completed DMC

• 2 other identifiers: GCO 19-1952R01NS117638
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Fatigue Syndrome; Myalgic Encephalomyelitis

Outcome Measures

Primary Outcomes (3)

• CPET testing

  To assess VO2VT and peak VO2

  2 days

• Total Blood Volume

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

  2 days

• Hypovolemia

  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

  1 day

Study Arms (2)

Saline Infusion

EXPERIMENTAL

Procedure: Saline Infusion

Sham Infusion

SHAM COMPARATOR

Procedure: Saline Infusion

Interventions

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.

Saline Infusion; Sham Infusion

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Ages 25 to 60
• Meet the 2015 IOM case definition for ME/CFS

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Benjamin Natelson, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Neurology

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 5, 2021
• Study Start: August 31, 2021
• Primary Completion: July 11, 2025
• Study Completion: July 11, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

US (1)