Cardiovascular Analysis of PEM

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Brief Title

Cardiovascular Analysis of PEM

Official Title

Cardiovascular Analysis of Post-exertional Malaise

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.
    



Study Type

Interventional


Primary Outcome

CPET testing


Condition

Myalgic Encephalomyelitis

Intervention

Saline Infusion

Study Arms / Comparison Groups

 Saline Infusion
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

80

Start Date

May 1, 2021

Completion Date

May 1, 2025

Primary Completion Date

May 1, 2025

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
      

Gender

All

Ages

25 Years - 60 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, , 



Administrative Informations


NCT ID

NCT04740736

Organization ID

GCO 19-1952


Responsible Party

Principal Investigator

Study Sponsor

Icahn School of Medicine at Mount Sinai


Study Sponsor

, , 


Verification Date

February 2021