Cardiovascular Analysis of PEM

Cardiovascular Analysis of Post-exertional Malaise

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.

Study Overview

• Status: Completed
• Conditions: Chronic Fatigue Syndrome; Myalgic Encephalomyelitis
• Intervention / Treatment: Procedure: Saline Infusion

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • ICAHN School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Saline Infusion	Procedure: Saline Infusion; Patient with hypovolemia on day 1 will be randomized to a saline or sham infusion prior to the Day 2 exercise test.
Sham Comparator: Sham Infusion	Procedure: Saline Infusion; Patient with hypovolemia on day 1 will be randomized to a saline or sham infusion prior to the Day 2 exercise test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
• Investigators: Principal Investigator: Benjamin Natelson, MD, ICAHN School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2021
• Primary Completion (Actual): July 11, 2025
• Study Completion (Actual): July 11, 2025

Study Registration Dates

• First Submitted: February 2, 2021
• First Submitted That Met QC Criteria: February 2, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Estimated): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neuroinflammatory Diseases; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Pathologic Processes; Encephalomyelitis; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathological Conditions, Signs and Symptoms; Fatigue Syndrome, Chronic
• Other Study ID Numbers: GCO 19-1952; R01NS117638 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No