Cardiovascular Analysis of PEM

• Sponsor: Icahn School of Medicine at Mount Sinai (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04740736
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 44
• Patients Per Site Per Month: 1.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Myalgic Encephalomyelitis; Chronic Fatigue Syndrome	Procedure: Saline Infusion	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Cardiovascular Analysis of Post-exertional Malaise
• Actual Study Start Date: Aug 31, 2021
• Anticipated Primary Completion Date: May 1, 2025
• Anticipated Study Completion Date: May 1, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. CPET testing [2 days]

   To assess VO2VT and peak VO2

2. Total Blood Volume [2 days]

   To measure Total Blood Volume (TBV) before each exercise test

3. Hypovolemia [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 60 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029

Sponsors and Collaborators

• Icahn School of Medicine at Mount Sinai

Investigators

• Principal Investigator: Benjamin Natelson, MD, Icahn School of Medicine at Mount Sinai

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Feb 5, 2021
• Last Update Posted: Oct 25, 2021
• Last Verified: Oct 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Fatigue Syndrome, Chronic; Encephalomyelitis

Study Results

No Results Posted as of Oct 25, 2021