Cardiovascular Analysis of Post-exertional Malaise
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Myalgic Encephalomyelitis
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Enrollment
- 106
- Locations
- 1
- Primary Endpoint
- CPET testing
- Status
- Completed
- Last Updated
- 4 months ago
Overview
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.
Investigators
Benjamin Natelson
Professor, Neurology
Icahn School of Medicine at Mount Sinai
Eligibility Criteria
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
Outcomes
Primary Outcomes
CPET testing
Time Frame: 2 days
To assess VO2VT and peak VO2
Total Blood Volume
Time Frame: 2 days
To measure Total Blood Volume (TBV) before each exercise test
Hypovolemia
Time Frame: 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