Cardiovascular Analysis of PEM

Launched by ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · Feb 2, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at how heart and lung function affects patients with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), particularly focusing on a common symptom called Post-exertional malaise (PEM), which is a worsening of symptoms after physical or mental activity. In this study, participants will complete two exercise tests on consecutive days to see how their bodies respond. Before the second test, patients who show low blood volume (hypovolemia) on the first day will receive either a saline solution or a placebo (sham infusion) to compare the effects.

To join the trial, participants need to be between 25 and 60 years old and meet specific criteria for ME/CFS. However, people with certain medical conditions, mental health issues, or those taking specific medications that could affect heart function during exercise won't be eligible. The study is currently recruiting a total of 80 participants, and it offers a chance to contribute to understanding this complex condition while receiving assessments of heart and lung health.

Gender

ALL

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