NCT04740736Completed
Cardiovascular Analysis of PEM
Cardiovascular Analysis of Post-exertional Malaise
Source: ClinicalTrials.gov · Last updated 18 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 106 (actual)
- First submitted
- 2 Feb 2021
- Start date
- 31 Aug 2021
- Primary completion date
- 11 Jul 2025
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT04740736
What you commit to
- Study type: Interventional
- Participants enrolled: 106
- From 31 Aug 2021 to the primary completion date, 11 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Patients with a medical cause for their fatigue
Who the study is looking for
- Ages 25 to 60
- Meet the 2015 IOM case definition for ME/CFS
Age in the registry: 25 years to 60 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.