Cardiovascular Analysis of PEM

Description

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

Study Overview

Study Details

Study overview

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.

Cardiovascular Analysis of Post-exertional Malaise

Cardiovascular Analysis of PEM

Condition
Myalgic Encephalomyelitis
Intervention / Treatment

-

Contacts and Locations

New York

Icahn School of Medicine at Mount Sinai, New York, New York, United States, 10029

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Ages 25 to 60
  • * Meet the 2015 IOM case definition for ME/CFS
  • * 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

Ages Eligible for Study

25 Years to 60 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Icahn School of Medicine at Mount Sinai,

Benjamin Natelson, MD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

2025-02-28