Working… Menu

Cardiovascular Analysis of PEM

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04740736
Recruitment Status : Not yet recruiting
First Posted : February 5, 2021
Last Update Posted : February 5, 2021
Information provided by (Responsible Party):
Benjamin Natelson, Icahn School of Medicine at Mount Sinai

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.

Condition or disease Intervention/treatment Phase
Myalgic Encephalomyelitis Chronic Fatigue Syndrome Procedure: Saline Infusion Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Cardiovascular Analysis of Post-exertional Malaise
Estimated Study Start Date : May 1, 2021
Estimated Primary Completion Date : May 1, 2025
Estimated Study Completion Date : May 1, 2025

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Saline Infusion Procedure: Saline Infusion
Patient with hypovolemia on day 1 will be randomized to a saline or sham infusion prior to the Day 2 exercise test.

Sham Comparator: Sham Infusion Procedure: Saline Infusion
Patient with hypovolemia on day 1 will be randomized to a saline or sham infusion prior to the Day 2 exercise test.

Primary Outcome Measures :
  1. CPET testing [ Time Frame: 2 days ]
    To assess VO2VT and peak VO2

  2. Total Blood Volume [ Time Frame: 2 days ]
    To measure Total Blood Volume (TBV) before each exercise test

  3. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Layout table for additonal information
Responsible Party: Benjamin Natelson, Professor, Neurology, Icahn School of Medicine at Mount Sinai Identifier: NCT04740736    
Other Study ID Numbers: GCO 19-1952
First Posted: February 5, 2021    Key Record Dates
Last Update Posted: February 5, 2021
Last Verified: February 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Fatigue Syndrome, Chronic
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases
Central Nervous System Infections