Cardiovascular Analysis of PEM

Mount Sinai Health System

Status: Completed

Conditions: Myalgic Encephalomyelitis; Chronic Fatigue Syndrome

Treatments: Procedure: Saline Infusion

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04740736

GCO 19-1952

R01NS117638 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 106 patients

Sex: All

Ages: 25 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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106 participants in 2 patient groups

Saline Infusion

Experimental group

Treatment:

Procedure: Saline Infusion

Sham Infusion

Sham Comparator group

Treatment:

Procedure: Saline Infusion