Cardiovascular Analysis of PEM

ID#: NCT04740736

Age: 25 - 60 years

Gender: All

Healthy Subjects: Accepts Healthy Volunteers

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: August 31, 2021

End Date: May 01, 2025

Contact Information:
Tiffany So
212-241-1438
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.
Eligibility:

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