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Cardiovascular Analysis of PEM

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ClinicalTrials.gov Identifier: NCT04740736
Recruitment Status : Not yet recruiting
First Posted : February 5, 2021
Last Update Posted : February 5, 2021
Sponsor:
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

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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

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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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Responsible Party: Benjamin Natelson, Professor, Neurology, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov 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

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