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Cardiovascular Analysis of PEM

Primary Purpose

Myalgic Encephalomyelitis, Chronic Fatigue Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Saline Infusion
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myalgic Encephalomyelitis

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesAccepts 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

Sites / Locations

  • Icahn School of Medicine at Mount SinaiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Saline Infusion

Sham Infusion

Arm Description

Outcomes

Primary Outcome Measures

CPET testing
To assess VO2VT and peak VO2
Total Blood Volume
To measure Total Blood Volume (TBV) before each exercise test
Hypovolemia
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

Secondary Outcome Measures

Full Information

First Posted
February 2, 2021
Last Updated
February 23, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT04740736
Brief Title
Cardiovascular Analysis of PEM
Official Title
Cardiovascular Analysis of Post-exertional Malaise
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 31, 2021 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myalgic Encephalomyelitis, Chronic Fatigue Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Saline Infusion
Arm Type
Experimental
Arm Title
Sham Infusion
Arm Type
Sham Comparator
Intervention Type
Procedure
Intervention Name(s)
Saline Infusion
Intervention Description
Patient with hypovolemia on day 1 will be randomized to a saline or sham infusion prior to the Day 2 exercise test.
Primary Outcome Measure Information:
Title
CPET testing
Description
To assess VO2VT and peak VO2
Time Frame
2 days
Title
Total Blood Volume
Description
To measure Total Blood Volume (TBV) before each exercise test
Time Frame
2 days
Title
Hypovolemia
Description
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
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tiffany So
Phone
212-241-1438
Email
tiffany.soto@mssm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Natelson, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin Natelson, MD

12. IPD Sharing Statement

Learn more about this trial

Cardiovascular Analysis of PEM

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