Cardiovascular Analysis of PEM

Not Applicable

Recruiting

• Conditions: Chronic Fatigue Syndrome; Myalgic Encephalomyelitis
• Interventions: Procedure: Saline Infusion

• Registration Number: NCT04740736
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-02
• Study First Submitted QC: 2021-02-02
• Study First Posted: 2021-02-05
• Study Start: 2021-08-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-28
• Last Update Posted: 2025-03-04
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 47

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Infusion	Saline Infusion	-
Saline Infusion	Saline Infusion	-

Primary Outcome Measures

Name	Time	Method
CPET testing	2 days	To assess VO2VT and peak VO2
Total Blood Volume	2 days	To measure Total Blood Volume (TBV) before each exercise test
Hypovolemia	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

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States