Cardiovascular Analysis of PEM

Chronic Fatigue Syndrome Clinical Trial

Official title:

Cardiovascular Analysis of Post-exertional Malaise

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04740736
• Other study ID #: GCO 19-1952
• Secondary ID: R01NS117638
• Status: Recruiting
• Phase: N/A
• Start date: August 31, 2021
• Est. completion date: February 28, 2025

Study information

• Verified date: February 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Tiffany So
• Phone: 212-241-1438
• Email: tiffany.soto[@]mssm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 47
• Est. completion date: February 28, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Fatigue Syndrome
• Encephalomyelitis
• Fatigue Syndrome, Chronic
• Myalgic Encephalomyelitis

Intervention

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.

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CPET testing	To assess VO2VT and peak VO2	2 days
Primary	Total Blood Volume	To measure Total Blood Volume (TBV) before each exercise test	2 days
Primary	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	1 day