The Exercise Response to Pharmacologic Cholinergic Stimulation in Myalgic Encephalomyelitis / Chronic Fatigue Syndrome
Last updated on July 2021Recruitment
- Recruitment Status
- Enrolling by invitation
- Estimated Enrollment
- 25
Summary
- Conditions
- Chronic Fatigue Syndrome
- Dysautonomia
- Exercise Intolerance
- Fibromyalgia
- Low Ventricular Filling Pressures (Preload Failure)
- Myalgic Encephalomyelitis
- Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
- Orthostatic Hypotension
- Postural Orthostatic Tachycardia Syndrome
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Subjects will be assigned ramsomly to receive either pyridostigmine or placebo, both study participants and investigators will be blinded.Masking: Triple (Participant, Care Provider, Investigator)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
Description
The hypothesis of our study is that hemodynamic, ventilatory and oxygen exchange variables such biventricular filling pressures and systemic oxygen extraction can be improved by cholinergic stimulation in patients with ME/CFS. The objective of this study is to examine the exercise response to pharma...
The hypothesis of our study is that hemodynamic, ventilatory and oxygen exchange variables such biventricular filling pressures and systemic oxygen extraction can be improved by cholinergic stimulation in patients with ME/CFS. The objective of this study is to examine the exercise response to pharmacologic cholinergic stimulation in ME/CFS patients already undergoing a clinically indicated level 3 cardiopulmonary exercise test (CPET). This will be achieved by inhibiting acetylcholinesterase with pyridostigmine, thus increasing acetylcholine levels, downstream levels of norepinephrine, and enhancing vascular regulation. To test our hypothesis, we propose the following specific aims: Define the response of peak oxygen uptake (VO2) to pyridostigmine. Define the gas exchange responses, such as end-tidal CO2 and ventilatory efficiency to pyridostigmine. Define the hemodynamic responses, such as right atrial pressures, pulmonary artery pressure, pulmonary capillary wedge pressures, cardiac output, heart rate, stroke volume, pulmonary vascular resistance and systemic vascular resistance to pyridostigmine. Evaluate the response of skeletal muscle oxygen extraction and lactate to pyridostigmine. These determinations will occur during a clinically indicated level 3 CPET, which includes exercising on a stationary cycle with a right heart catheter (RHC) and a radial arterial line in place. To stimulate the cholinergic response, a single dose of an oral acetylcholinesterase inhibitor, pyridostigmine, versus placebo will be given after the level 3 CPET. Recovery cycling will be performed after a rest period of 50 minutes. This will be administered in a randomized, double-blind, placebo-controlled trial.
Tracking Information
- NCT #
- NCT03674541
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: David Systrom, MD Brigham and Women's Hospital
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