NCT04740736

Cardiovascular Analysis of PEM

Cardiovascular Analysis of Post-exertional Malaise

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 25 Years – 60 Years
• Healthy volunteers: Accepted

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

• Myalgic Encephalomyelitis
• Chronic Fatigue Syndrome

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-08-31
• Primary completion: 2025-07-11
• Completion: 2025-07-11
• First posted: 2021-02-05
• Last updated: 2025-12-18

Locations

1 site across 1 country: United States