Examining heart function in Chronic Fatigue Syndrome patients
Cardiovascular Analysis of Post-exertional Malaise
This study is testing how heart function is affected in people with Chronic Fatigue Syndrome and whether treating low blood volume can help them feel better during exercise.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 47 (estimated) |
| Ages | 25 Years to 60 Years |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT04740736 on ClinicalTrials.gov |
What this trial studies
This study investigates cardiopulmonary function in patients with Chronic Fatigue Syndrome (CFS) and its relationship to Post-exertional malaise (PEM). Participants will undergo maximal exercise tests on two consecutive days, with blood volume measured before each test. Patients identified with hypovolemia on the first day will be randomly assigned to receive either a saline or sham infusion before the second test. The study aims to enroll a total of 80 CFS patients to better understand the cardiovascular aspects of their condition.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 25 to 60 who meet the 2015 IOM case definition for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome.
Not a fit: Patients with fatigue due to other medical causes or those with certain psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of cardiovascular issues in CFS patients, potentially enhancing their quality of life.
How similar studies have performed: While there is ongoing research in this area, this specific approach to examining cardiovascular function in CFS patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Benjamin Natelson, MD — Icahn School of Medicine at Mount Sinai
- Study coordinator: Tiffany So
- Email: tiffany.soto@mssm.edu
- Phone: 212-241-1438
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.