Myalgic Encephalomyelitis/Chronic Fatigue SyndromePhase 2NCT03674541
The Exercise Response to Pharmacologic Cholinergic Stimulation in Myalgic Encephalomyelitis / Chronic Fatigue Syndrome
A Phase 2 study testing Pyridostigmine Bromide in people with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome and Chronic Fatigue Syndrome, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Myalgic encephalomyelitis/Chronic fatigue syndrome (ME/CFS), otherwise known as Chronic fatigue syndrome (CFS) or myalgic encephalomyelitis (ME), is an under-recognized disorder whose cause is not yet understood. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, Chronic Fatigue Syndrome, Myalgic Encephalomyelitis
- What is being tested?
- Pyridostigmine Bromide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2020to 20 Dec 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets the Institute of Medicine (IOM) criteria for ME/CFS
- Completing the clinically indicated invasive cardiopulmonary exercise test (iCPET)
Who cannot join
- Obesity (BMI > 30 kg/m2)
- Non-controlled asthma
- Anemia (Hb < 10 g/dl)
- Active or treated cancer
- History of interstitial lung disease (ILD)
- Chronic obstructive pulmonary disease (COPD)
Show all 21Show fewer
- Pulmonary hypertension (PH)
- Congestive heart failure (CHF)
- Active arrhythmias
- Valvular heart disease
- Coronary artery disease (CAD)
- Other conditions that could predict a limitation or not completion of the study.
- Pregnancy
- Submaximal testing in clinically indicated iCPET
- Pulmonary mechanical limitation to exercise in clinically indicated iCPET.
- Pulmonary arterial hypertension in clinically indicated iCPET.
- Pulmonary venous hypertension in clinically indicated iCPET.
- Exercise induced pulmonary arterial hypertension in clinically indicated iCPET.
- Exercise induced pulmonary venous hypertension in clinically indicated iCPET.
- Persistent hypotension during or after the clinically indicated iCPET.
- Refractory arrhythmia during or after the clinically indicated level 3 CPET.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02215
About this study
Myalgic encephalomyelitis/Chronic fatigue syndrome (ME/CFS), otherwise known as Chronic fatigue syndrome (CFS) or myalgic encephalomyelitis (ME), is an under-recognized disorder whose cause is not yet understood. Suggested theories behind the pathophysiology of this condition include autoimmune causes, an inciting viral illness, and a dysfunctional autonomic nervous system caused by a small fiber polyneuropathy. Symptoms include fatigue, cognitive impairments, gastrointestinal changes, exertional dyspnea, and post-exertional malaise. The latter two symptoms are caused in part by abnormal cardiopulmonary hemodynamics during exercise thought to be due to a small fiber polyneuropathy. This manifests as low biventricular filling pressures throughout exercise seen in patients undergoing an invasive cardiopulmonary exercise test (iCPET) along with small nerve fiber atrophy seen on skin biopsy.
After diagnosis, patients are often treated with pyridostigmine (off-label use of this medication) to enhance cholinergic stimulation of norepinephrine release at the post-ganglionic synapse. This is thought to improve venoconstriction at the site of exercising muscles, leading to improved return of blood to the heart and increasing filling of the heart to more appropriate levels during peak exercise. Retrospective studies have shown that noninvasive measurements of exercise capacity, such as oxygen uptake, end-tidal carbon dioxide, and ventilatory efficiency, improve after treatment with pyridostigmine. To date, there are no studies that assess invasive hemodynamics after pyridostigmine administration.
It is estimated that four million people suffer from ME/CFS worldwide, a number that is thought to be a gross underestimate of disease prevalence. However, despite its potential for debilitating symptoms, loss of productivity, and worldwide burden, the pathophysiology behind ME/CFS remains unknown and its treatment unclear. By evaluating the exercise response to cholinergic stimulation, this study will shed further light on the link between the autonomic nervous system and cardiopulmonary hemodynamics, potentially leading to new therapeutic targets.
Read the detailed 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 pharmacologic cholinergic stimulation in ME/CFS patients already undergoing a clinically indicated invasive cardiopulmonary exercise test (iCPET). 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 carbon dioxide(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 iCPET, 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 iCPET. Recovery cycling will be performed after a rest period of 50 minutes. This will be administered in a randomized, double-blind, placebo-controlled trial.
- Conditions
- Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, Chronic Fatigue Syndrome, Myalgic Encephalomyelitis, Exercise Intolerance, Dysautonomia, Low Ventricular Filling Pressures (Preload Failure)
- Being tested
- Pyridostigmine Bromide, Placebo
- Keywords
- Myalgic encephalomyelitis/Chronic fatigue syndrome, Myalgic encephalomyelitis, Chronic fatigue syndrome, Pyridostigmine, Exercise Intolerance, Invasive Cardiopulmonary Exercise Test
- Medical subject headings
- Fatigue Syndrome, Chronic, Autonomic Nervous System Diseases, Postural Orthostatic Tachycardia Syndrome, Hypotension, Orthostatic, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pyridostigmine BromideDrug
Also called Mestinon
Pyridostigmine Bromide 60 mg capsule by mouth as a one time dose
PlaceboDrug
Also called Cellulose microcrystalline
Placebo (Cellulose microcrystalline) capsule by mouth as a one time dose
| Study group | Role | What they receive |
|---|---|---|
| Study Drug - Pyridostigmine | Active comparator | Pyridostigmine 60 mg by mouth as a one time dose Receives: Drug: Pyridostigmine Bromide |
| Placebo | Placebo comparator | Placebo by mouth as a one time dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Peak Oxygen Uptake (Peak VO2) Between the First and Second iCPET
Define the response of oxygen uptake to pyridostigmine expressed both as mL/min and mL/min/kg. The difference in peak oxygen uptake from first iCPET to second iCPET. Research has shown that ME/CFS patients have inability to reproduce results on two consecutive cardiopulmonary exercise tests(CPET). Traditionally this is demonstrated with a two-day CPET protocol, but in this study we investigate the acute effects of pyridostigmine administration on the early stages of post exertional malaise(PEM).
Measured: First iCPET up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes.
Secondary outcomes (11)
Peak-Rest Oxygen Uptake (VO2)
Peak versus rest changes in oxygen uptake between first and second CPETs expressed as mL/min.
Measured: First iCPET up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes.
Peak Cardiac Output (Qc)
Arterial and mixed-venous blood gases and pH are measured at peak exercise and Qc is calculated using the direct Fick principle Qc=VO2/(Ca-Cv). Change in peak Qc between first and second iCPETs is measured in L/min.
Measured: First iCPET up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes.
Peak-Rest Cardiac Output (Qc)
Peak versus rest change in cardiac output expressed in L/min between first and second iCPETs. Cardiac output is determined using the direct Fick principle.
Measured: First iCPET up to 30 min, 50 minutes rest, second iCPET up to 30 minutes
Peak Right Atrial Pressure (RAP)
Difference in peak RAP between first and second iCPETs measured in mmHg.
Measured: First iCPEt up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes.
Peak-Rest Right Atrial Pressure (RAP)
Peak versus rest changes in RAP between first and second iCPETs measured in mmHg
Measured: First iCPEt up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes.
Peak Pulmonary Arterial Wedge Pressure (PAWP)
Difference in peak PAWP between first and second iCPETs measured in mmHg
Measured: First iCPET up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes.
Peak Stroke Volume (SV)
Difference in peak SV between first and second iCPETs measured in mL
Measured: First iCPEt up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes.
Peak (Ca-vO2)/[Hgb]
Difference in peak arterial-venous oxygen content difference normalized to hemoglobin (Ca-vO2)/[Hgb] between first and second iCPETs
Measured: First iCPET up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes.
Ventilatory Efficiency (VE/VCO2)
Difference in ventilatory efficiency between first and second iCPETs
Measured: First iCPET up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes.
Borg Fatigue Scale
Difference in perception of fatigue at peak exercise between first and second iCPETs. Used Borg Scale 0 (minimal) to 10 (maximal).
Measured: First iCPET up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes.
Borg Dyspnea Scale
Difference in perceived dyspnea at peak exercise between first and second iCPETs. Used Borg Scale 0 (minimal) to 10 (maximal).
Measured: First iCPET up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start14 Jan 2020
- Primary completion5 Dec 2021
- Study completion20 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myalgic Encephalomyelitis/Chronic Fatigue SyndromeStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be assigned randomly to receive either pyridostigmine or placebo, both study participants and investigators will be blinded.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Systrom, Brigham and Women's Hospital
- Investigators
- David Systrom, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03674541
- Sponsor's protocol ID
- 2018P001871
- Status last verified
- Oct 2022
- First submitted
- 11 Sep 2018
- Last updated
- 8 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after de-identification(text, tables, figures, and appendices) will be available for researchers who provide a methodologically sound proposal to achieve aims in the approved proposal.
Publications
Joseph P, Pari R, Miller S, Warren A, Stovall MC, Squires J, Chang CJ, Xiao W, Waxman AB, Systrom DM. Neurovascular Dysregulation and Acute Exercise Intolerance in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: A Randomized, Placebo-Controlled Trial of Pyridostigmine. Chest. 2022 Nov;162(5):1116-1126. doi: 10.1016/j.chest.2022.04.146. Epub 2022 May 6.
PubMed 35526605
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Exercise Response to Pharmacologic Cholinergic Stimulation in Myalgic Encephalomyelitis / Chronic Fatigue Syndrome
- ClinicalTrials.gov ID
- NCT03674541
- Acronym / sponsor ID
- 2018P001871
- Conditions
- Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, Chronic Fatigue Syndrome, Myalgic Encephalomyelitis, Exercise Intolerance, Dysautonomia, Low Ventricular Filling Pressures (Preload Failure)
- Keywords
- Myalgic encephalomyelitis/Chronic fatigue syndrome, Myalgic encephalomyelitis, Chronic fatigue syndrome, Pyridostigmine, Exercise Intolerance, Invasive Cardiopulmonary Exercise Test
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 5 Dec 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 17 Sep 2018 (actual)
- Results
- Posted 4 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Myalgic encephalomyelitis/Chronic fatigue syndrome (ME/CFS), otherwise known as Chronic fatigue syndrome (CFS) or myalgic encephalomyelitis (ME), is an under-recognized disorder whose cause is not yet understood. Suggested theories behind the pathophysiology of this condition include autoimmune causes, an inciting viral illness, and a dysfunctional autonomic nervous system caused by a small fiber polyneuropathy. Symptoms include fatigue, cognitive impairments, gastrointestinal changes, exertional dyspnea, and post-exertional malaise. The latter two symptoms are caused in part by abnormal cardiopulmonary hemodynamics during exercise thought to be due to a small fiber polyneuropathy. This manifests as low biventricular filling pressures throughout exercise seen in patients undergoing an invasive cardiopulmonary exercise test (iCPET) along with small nerve fiber atrophy seen on skin biopsy.
After diagnosis, patients are often treated with pyridostigmine (off-label use of this medication) to enhance cholinergic stimulation of norepinephrine release at the post-ganglionic synapse. This is thought to improve venoconstriction at the site of exercising muscles, leading to improved return of blood to the heart and increasing filling of the heart to more appropriate levels during peak exercise. Retrospective studies have shown that noninvasive measurements of exercise capacity, such as oxygen uptake, end-tidal carbon dioxide, and ventilatory efficiency, improve after treatment with pyridostigmine. To date, there are no studies that assess invasive hemodynamics after pyridostigmine administration.
It is estimated that four million people suffer from ME/CFS worldwide, a number that is thought to be a gross underestimate of disease prevalence. However, despite its potential for debilitating symptoms, loss of productivity, and worldwide burden, the pathophysiology behind ME/CFS remains unknown and its treatment unclear. By evaluating the exercise response to cholinergic stimulation, this study will shed further light on the link between the autonomic nervous system and cardiopulmonary hemodynamics, potentially leading to new therapeutic targets.
Detailed 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 pharmacologic cholinergic stimulation in ME/CFS patients already undergoing a clinically indicated invasive cardiopulmonary exercise test (iCPET). 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 carbon dioxide(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 iCPET, 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 iCPET. Recovery cycling will be performed after a rest period of 50 minutes. This will be administered in a randomized, double-blind, placebo-controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Subjects will be assigned randomly to receive either pyridostigmine or placebo, both study participants and investigators will be blinded.
| Arm | Type | Receives |
|---|---|---|
| Study Drug - Pyridostigmine | Active comparator | Drug: Pyridostigmine BromidePyridostigmine 60 mg by mouth as a one time dose |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo by mouth as a one time dose |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Meets the Institute of Medicine (IOM) criteria for ME/CFS
- Completing the clinically indicated invasive cardiopulmonary exercise test (iCPET)
Key exclusion criteria (21 listed)
- Obesity (BMI > 30 kg/m2)
- Non-controlled asthma
- Anemia (Hb < 10 g/dl)
- Active or treated cancer
- History of interstitial lung disease (ILD)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pyridostigmine BromideAlso: MestinonPyridostigmine Bromide 60 mg capsule by mouth as a one time dose | Drug | Study Drug - Pyridostigmine |
| PlaceboAlso: Cellulose microcrystallinePlacebo (Cellulose microcrystalline) capsule by mouth as a one time dose | Drug | Placebo |
Primary outcome
Change in Peak Oxygen Uptake (Peak VO2) Between the First and Second iCPET
Time frame: First iCPET up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes.
Define the response of oxygen uptake to pyridostigmine expressed both as mL/min and mL/min/kg. The difference in peak oxygen uptake from first iCPET to second iCPET. Research has shown that ME/CFS patients have inability to reproduce results on two consecutive cardiopulmonary exercise tests(CPET). Traditionally this is demonstrated with a two-day CPET protocol, but in this study we investigate the acute effects of pyridostigmine administration on the early stages of post exertional malaise(PEM).
11 secondary outcomes
Peak-Rest Oxygen Uptake (VO2)
Time frame: First iCPET up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes.
Peak Cardiac Output (Qc)
Time frame: First iCPET up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes.
Peak-Rest Cardiac Output (Qc)
Time frame: First iCPET up to 30 min, 50 minutes rest, second iCPET up to 30 minutes
Peak Right Atrial Pressure (RAP)
Time frame: First iCPEt up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes.
Peak-Rest Right Atrial Pressure (RAP)
Time frame: First iCPEt up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes.
Peak Pulmonary Arterial Wedge Pressure (PAWP)
Time frame: First iCPET up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes.
Peak Stroke Volume (SV)
Time frame: First iCPEt up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes.
Peak (Ca-vO2)/[Hgb]
Time frame: First iCPET up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes.
Ventilatory Efficiency (VE/VCO2)
Time frame: First iCPET up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes.
Borg Fatigue Scale
Time frame: First iCPET up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes.
Borg Dyspnea Scale
Time frame: First iCPET up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35526605Joseph P, Pari R, Miller S, Warren A, Stovall MC, Squires J, Chang CJ, Xiao W, Waxman AB, Systrom DM. Neurovascular Dysregulation and Acute Exercise Intolerance in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: A Randomized, Placebo-Controlled Trial of Pyridostigmine. Chest. 2022 Nov;162(5):1116-1126. doi: 10.1016/j.chest.2022.04.146. Epub 2022 May 6.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after de-identification(text, tables, figures, and appendices) will be available for researchers who provide a methodologically sound proposal to achieve aims in the approved proposal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Systrom, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pyridostigmine Bromide in people with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome and Chronic Fatigue Syndrome, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Peak Oxygen Uptake (Peak VO2) Between the First and Second iCPET (time frame: First iCPET up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03674541, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.