Chronic Fatigue SyndromeNCT03029377
Noradrenergic and Stress-Related Etiologies of Chronic Fatigue Syndrome
A study testing Posture Study, Autonomic Function Tests, and a Stress Test in people with Chronic Fatigue Syndrome, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The objective of this study is to measure sympathetic nervous system function and stress responses in patients with clinically documented and self-reported chronic fatigue that is worsened by stress, compared to healthy controls. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Fatigue Syndrome
- What is being tested?
- Posture Study, Autonomic Function Tests, and a Stress Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to 23 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Confirmed chronic fatigue with severity >50 on a scale of 1 to 100 that is not improving over time
- Meet The Centers for Disease Control and Prevention (CDC) diagnostic criteria of CFS (self-reported persistent or relapsing fatigue lasting 6 or more consecutive months)
Who cannot join
- Male and female subjects <18 or >60 years
- Obesity, defined as a BMI of 30 or more
- Presence of other medical or psychiatric conditions known to cause fatigue (alcohol/drug abuse, anorexia nervosa, bipolar disorder, bulimia nervosa, dementia, major depression, psychotic/delusional disorders, schizophrenia)
- Presence of sleep disorder/disruption known to cause fatigue (sleep apnea, narcolepsy)
- Cardiovascular, pulmonary, hepatic, or hematological disease by history or prior testing defined as significant by investigator (including but not limited to chronic hepatitis, chronic kidney disease, cirrhosis, emphysema, heart failure, HIV, lupus, multiple sclerosis, myasthenia gravis, rheumatoid arthritis)
- History of hypertension defined as supine resting BP>145/95 mmHg off medications or needing antihypertensive medication
Show all 25Show fewer
- Patients taking medications that can affect autonomic function or plasma catecholamines (vasoactive drugs), stimulants, and/or are sedatives
- Other factors which in the opinion of the investigator could potentially impact the study outcomes (e.g., underlying disease, medications, history)* or prevent the participant from completing the protocol (poor compliance or unpredictable schedule)
- Inability to stand unassisted for 10 minutes
- Patients who are bedridden or chair-ridden
- Patients who are colorblind
- Inability or refusal to give informed consent for any reason including a diagnosis of dementia or cognitive impairment
- Patients who are pregnant or breastfeeding
- Healthy Control Participants:
- Participant with no significant reported conditions or medications.
- Male and female subjects <18 or >60 years
- Obesity, defined as a BMI of 30 or more
- Presence of any serious or chronic disease, or prescription medication as deemed by investigator including hypertension as defined by supine resting BP >145/95 mmHg off medications or needing antihypertensive medication
- Other factors which in the investigator's opinion would prevent the participant from completing the protocol, including poor compliance during previous studies or an unpredictable schedule
- Inability to stand unassisted for 10 minutes
- Patients who are bedridden or chair-ridden
- Patients who are colorblind
- Inability or refusal to give informed consent for any reason including a diagnosis of dementia or cognitive impairment
- Patients who are pregnant or breastfeeding
- Stress Overload Score above 66
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
About this study
The objective of this study is to measure sympathetic nervous system function and stress responses in patients with clinically documented and self-reported chronic fatigue that is worsened by stress, compared to healthy controls. Baseline norepinephrine (NE) levels and stress-induced NE levels in patients who fulfill criteria for Chronic Fatigue Syndrome (CFS) and who self-identify with stress induced worsening fatigue, will be compared to data from normal individuals pre and post-stress.
Read the detailed description
Symptoms of Chronic Fatigue Syndrome (CFS) are critically important to study as patients report that these symptoms are often profoundly debilitating and an impediment to effective daily functioning as well as effective vocational and social functioning, while also contributing to a significantly increased risk of psychiatric illness and diminished quality of life. Previous Phenome-Wide Association (PheWAS) studies revealed a link between a norepinephrine transporter (NET) genetic variant and CFS. Based on the potential function of the variant and published literature, elevated norepinephrine (NE) levels may underlie at least some cluster of fatigue symptoms. Some patients may experience chronic fatigue that is due to an excess of circulating NE, and fatigue symptoms are reported by our patient population to be commonly exacerbated by stress. This study will test the hypothesis that in a subset of people with severely debilitating fatigue of long duration (>6 months) that is worsened by stress identified through the Vanderbilt electronic health record phenotyping study, have chronic over-release of the hormone NE into the bloodstream/periphery over time that results in an overload of NE. This overload of NE causes a compensatory but deleterious effect on the brain and nervous system, including sympathetic effects and dysregulated physiologic response to stress. Thus, while numerous currently approved therapies that target NET inhibit the transporter, a drug with the opposite mechanism of action, a NET activator that would decrease circulating NE, may have efficacy in treating underlying pathophysiology of chronic fatigue.
Baseline NE levels and stress-induced NE levels in patients who fulfill criteria for CFS and who self-identify with stress induced worsening fatigue, will be compared to data from normal individuals pre and post-stress. After all inclusion criteria has been confirmed, an IV will be placed for blood collection, a continuous electrocardiographic trace and blood pressure cuff will be placed on the subject's arm and finger. Subjects will undergo a posture study, autonomic reflex testing, and Stroop stress testing each followed by blood specimen collection. An optional blood draw for DNA analysis will occur after patients have been provided lunch. Questionnaires will be completed after study procedures and patients have been provided lunch. Study blood collection will total up to 28 milliliters (mL): 5 mL for cytokines, 20 mL for catecholamines, and optional 3 mL for DNA.
- Conditions
- Chronic Fatigue Syndrome
- Being tested
- Posture Study, Autonomic Function Tests, and a Stress Test
- Keywords
- CFS, Stress, Norepinephrine Transporter (NET), Norepinephrine (NE), Healthy Controls, Fatigue
- Medical subject headings
- Fatigue Syndrome, Chronic, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posture Study, Autonomic Function Tests, and a Stress TestOther
Participants will undergo a Posture Study, Autonomic Function Tests, and a Stress Test. Participants' blood will be drawn to measure markers of sympathetic nervous system function at baseline, in three postural positions, after autonomic tests, and after a stress test.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Fatigue Patients | Experimental | Patients between 18-60 years of age with fatigue symptoms who meet preliminary chronic fatigue phenotype criteria and complete preliminary screening surveys. Participants will undergo a Posture Study, Autonomic Function Tests, and a Stress Test. Participants' blood will be drawn to measure markers of sympathetic nervous system function. Receives: Other: Posture Study, Autonomic Function Tests, and a Stress Test |
| Healthy Controls | Active comparator | Patients between 18-60 years of age with no known conditions or prescription medications who meet preliminary screening criteria. Participants will undergo a Posture Study, Autonomic Function Tests, and a Stress Test. Participants' blood will be drawn to measure markers of sympathetic nervous system function. Receives: Other: Posture Study, Autonomic Function Tests, and a Stress Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
dihydroxyphenylglycol (DHPG)/norepinephrine (NE) Ratio (post stress)
Change in DHPG/NE Ratio from Baseline to post stress compared across arms
Measured: Change from Baseline to post stress test (approximately 100 minutes post-baseline blood collection)
Secondary outcomes (12)
DHPG/NE Ratio (post Autonomic Function test)
Change in DHPG/NE Ratio from Baseline to post Autonomic Function test compared across arms
Measured: Change from Baseline to post Autonomic Function test (approximately 30 minutes post-baseline blood collection)
DHPG/NE Ratio (post Standing position)
Change in DHPG/NE Ratio from Baseline to post Standing position compared across arms
Measured: Change from Baseline to post Standing position (approximately 40 minutes post-baseline blood collection)
DHPG/NE Ratio (post Sitting position)
Change in DHPG/NE Ratio from Baseline to post Sitting position compared across arms
Measured: Change from Baseline to post Sitting position (approximately 70 minutes post-baseline blood collection)
Absolute DHPG and NE Levels (post stress)
Change in absolute DHPG and NE Levels from Baseline to post stress compared across arms
Measured: Change from Baseline to post stress test (approximately 100 minutes post-baseline blood collection)
Absolute DHPG and NE Levels (post Autonomic Function test)
Change in DHPG and NE levels from Baseline to post Autonomic Function test compared
Measured: Change from Baseline to post Autonomic Function test (approximately 30 minutes post-baseline blood collection)
Absolute DHPG and NE Levels (post Standing position)
Change in absolute DHPG and NE Levels from Baseline to post Standing position compared across arms
Measured: Change from Baseline to post Standing position (approximately 40 minutes post-baseline blood collection)
Absolute DHPG and NE Levels (post Sitting position)
Change in DHPG and NE levels from Baseline to post Sitting position compared across arms
Measured: Change from Baseline to post Sitting position (approximately 70 minutes post-baseline blood collection)
Fatigue as assessed by Multidimensional Assessment of Fatigue Scale (MAF)
Mean values +/- standard deviation (SD) compared across arms
Measured: End of Study Visit (approximately 140 minutes post-baseline blood collection)
Mood as assessed by Hospital Anxiety and Depression Scale (HADS)
Mean values +/- SD compared across arms
Measured: End of Study Visit (approximately 140 minutes post-baseline blood collection)
Quality of Life as assessed by 36-Item Short Form Survey Instrument (SF-36)
Mean values +/- SD compared across arms
Measured: End of Study Visit (approximately 140 minutes post-baseline blood collection)
Stress as assessed by Stress Overload Scale
Mean values +/- SD compared across arms
Measured: Beginning of Study Visit (Approximately 15 minutes pre-baseline blood collection)
Cytokines
Compared across arms
Measured: At baseline (approximately 30 minutes after supine position start)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2017 (estimated)
- Study startJan 2017
- Primary completion23 Feb 2018
- Study completion23 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Fatigue SyndromeStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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 N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gordon Bernard, Vanderbilt University Medical Center
- Investigators
- Gordon Bernard, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03029377
- Sponsor's protocol ID
- 161423
- Status last verified
- Apr 2018
- First submitted
- 9 Jan 2017
- Last updated
- 26 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Okamoto LE, Raj SR, Peltier A, Gamboa A, Shibao C, Diedrich A, Black BK, Robertson D, Biaggioni I. Neurohumoral and haemodynamic profile in postural tachycardia and chronic fatigue syndromes. Clin Sci (Lond). 2012 Feb;122(4):183-92. doi: 10.1042/CS20110200.
PubMed 21906029Shirey-Rice JK, Klar R, Fentress HM, Redmon SN, Sabb TR, Krueger JJ, Wallace NM, Appalsamy M, Finney C, Lonce S, Diedrich A, Hahn MK. Norepinephrine transporter variant A457P knock-in mice display key features of human postural orthostatic tachycardia syndrome. Dis Model Mech. 2013 Jul;6(4):1001-11. doi: 10.1242/dmm.012203. Epub 2013 Apr 4.
PubMed 23580201Danciu I, Cowan JD, Basford M, Wang X, Saip A, Osgood S, Shirey-Rice J, Kirby J, Harris PA. Secondary use of clinical data: the Vanderbilt approach. J Biomed Inform. 2014 Dec;52:28-35. doi: 10.1016/j.jbi.2014.02.003. Epub 2014 Feb 14.
PubMed 24534443
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noradrenergic and Stress-Related Etiologies of Chronic Fatigue Syndrome
- ClinicalTrials.gov ID
- NCT03029377
- Acronym / sponsor ID
- 161423
- Conditions
- Chronic Fatigue Syndrome
- Keywords
- CFS, Stress, Norepinephrine Transporter (NET), Norepinephrine (NE), Healthy Controls, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- 23 Feb 2018 (actual)
- Study completion
- 23 Feb 2018 (actual)
- First posted
- 24 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to measure sympathetic nervous system function and stress responses in patients with clinically documented and self-reported chronic fatigue that is worsened by stress, compared to healthy controls. Baseline norepinephrine (NE) levels and stress-induced NE levels in patients who fulfill criteria for Chronic Fatigue Syndrome (CFS) and who self-identify with stress induced worsening fatigue, will be compared to data from normal individuals pre and post-stress.
Detailed description
Symptoms of Chronic Fatigue Syndrome (CFS) are critically important to study as patients report that these symptoms are often profoundly debilitating and an impediment to effective daily functioning as well as effective vocational and social functioning, while also contributing to a significantly increased risk of psychiatric illness and diminished quality of life. Previous Phenome-Wide Association (PheWAS) studies revealed a link between a norepinephrine transporter (NET) genetic variant and CFS. Based on the potential function of the variant and published literature, elevated norepinephrine (NE) levels may underlie at least some cluster of fatigue symptoms. Some patients may experience chronic fatigue that is due to an excess of circulating NE, and fatigue symptoms are reported by our patient population to be commonly exacerbated by stress. This study will test the hypothesis that in a subset of people with severely debilitating fatigue of long duration (>6 months) that is worsened by stress identified through the Vanderbilt electronic health record phenotyping study, have chronic over-release of the hormone NE into the bloodstream/periphery over time that results in an overload of NE. This overload of NE causes a compensatory but deleterious effect on the brain and nervous system, including sympathetic effects and dysregulated physiologic response to stress. Thus, while numerous currently approved therapies that target NET inhibit the transporter, a drug with the opposite mechanism of action, a NET activator that would decrease circulating NE, may have efficacy in treating underlying pathophysiology of chronic fatigue.
Baseline NE levels and stress-induced NE levels in patients who fulfill criteria for CFS and who self-identify with stress induced worsening fatigue, will be compared to data from normal individuals pre and post-stress. After all inclusion criteria has been confirmed, an IV will be placed for blood collection, a continuous electrocardiographic trace and blood pressure cuff will be placed on the subject's arm and finger. Subjects will undergo a posture study, autonomic reflex testing, and Stroop stress testing each followed by blood specimen collection. An optional blood draw for DNA analysis will occur after patients have been provided lunch. Questionnaires will be completed after study procedures and patients have been provided lunch. Study blood collection will total up to 28 milliliters (mL): 5 mL for cytokines, 20 mL for catecholamines, and optional 3 mL for DNA.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Fatigue Patients | Experimental | Other: Posture Study, Autonomic Function Tests, and a Stress TestPatients between 18-60 years of age with fatigue symptoms who meet preliminary chronic fatigue phenotype criteria and complete preliminary screening surveys. Participants will undergo a Posture Study, Autonomic Function Tests, and a Stress Test. Participants' blood will be drawn to measure markers of sympathetic nervous system function. |
| Healthy Controls | Active comparator | Other: Posture Study, Autonomic Function Tests, and a Stress TestPatients between 18-60 years of age with no known conditions or prescription medications who meet preliminary screening criteria. Participants will undergo a Posture Study, Autonomic Function Tests, and a Stress Test. Participants' blood will be drawn to measure markers of sympathetic nervous system function. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Confirmed chronic fatigue with severity >50 on a scale of 1 to 100 that is not improving over time
- Meet The Centers for Disease Control and Prevention (CDC) diagnostic criteria of CFS (self-reported persistent or relapsing fatigue lasting 6 or more consecutive months)
Key exclusion criteria (25 listed)
- Male and female subjects <18 or >60 years
- Obesity, defined as a BMI of 30 or more
- Presence of other medical or psychiatric conditions known to cause fatigue (alcohol/drug abuse, anorexia nervosa, bipolar disorder, bulimia nervosa, dementia, major depression, psychotic/delusional disorders, schizophrenia)
- Presence of sleep disorder/disruption known to cause fatigue (sleep apnea, narcolepsy)
- Cardiovascular, pulmonary, hepatic, or hematological disease by history or prior testing defined as significant by investigator (including but not limited to chronic hepatitis, chronic kidney disease, cirrhosis, emphysema, heart failure, HIV, lupus, multiple sclerosis, myasthenia gravis, rheumatoid arthritis)
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 |
|---|---|---|
| Posture Study, Autonomic Function Tests, and a Stress TestParticipants will undergo a Posture Study, Autonomic Function Tests, and a Stress Test. Participants' blood will be drawn to measure markers of sympathetic nervous system function at baseline, in three postural positions, after autonomic tests, and after a stress test. | Other | Chronic Fatigue Patients, Healthy Controls |
Primary outcome
dihydroxyphenylglycol (DHPG)/norepinephrine (NE) Ratio (post stress)
Time frame: Change from Baseline to post stress test (approximately 100 minutes post-baseline blood collection)
Change in DHPG/NE Ratio from Baseline to post stress compared across arms
12 secondary outcomes
DHPG/NE Ratio (post Autonomic Function test)
Time frame: Change from Baseline to post Autonomic Function test (approximately 30 minutes post-baseline blood collection)
DHPG/NE Ratio (post Standing position)
Time frame: Change from Baseline to post Standing position (approximately 40 minutes post-baseline blood collection)
DHPG/NE Ratio (post Sitting position)
Time frame: Change from Baseline to post Sitting position (approximately 70 minutes post-baseline blood collection)
Absolute DHPG and NE Levels (post stress)
Time frame: Change from Baseline to post stress test (approximately 100 minutes post-baseline blood collection)
Absolute DHPG and NE Levels (post Autonomic Function test)
Time frame: Change from Baseline to post Autonomic Function test (approximately 30 minutes post-baseline blood collection)
Absolute DHPG and NE Levels (post Standing position)
Time frame: Change from Baseline to post Standing position (approximately 40 minutes post-baseline blood collection)
Absolute DHPG and NE Levels (post Sitting position)
Time frame: Change from Baseline to post Sitting position (approximately 70 minutes post-baseline blood collection)
Fatigue as assessed by Multidimensional Assessment of Fatigue Scale (MAF)
Time frame: End of Study Visit (approximately 140 minutes post-baseline blood collection)
Mood as assessed by Hospital Anxiety and Depression Scale (HADS)
Time frame: End of Study Visit (approximately 140 minutes post-baseline blood collection)
Quality of Life as assessed by 36-Item Short Form Survey Instrument (SF-36)
Time frame: End of Study Visit (approximately 140 minutes post-baseline blood collection)
Stress as assessed by Stress Overload Scale
Time frame: Beginning of Study Visit (Approximately 15 minutes pre-baseline blood collection)
Cytokines
Time frame: At baseline (approximately 30 minutes after supine position start)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2018.
- Background: PubMed 21906029Okamoto LE, Raj SR, Peltier A, Gamboa A, Shibao C, Diedrich A, Black BK, Robertson D, Biaggioni I. Neurohumoral and haemodynamic profile in postural tachycardia and chronic fatigue syndromes. Clin Sci (Lond). 2012 Feb;122(4):183-92. doi: 10.1042/CS20110200.
- Background: PubMed 23580201Shirey-Rice JK, Klar R, Fentress HM, Redmon SN, Sabb TR, Krueger JJ, Wallace NM, Appalsamy M, Finney C, Lonce S, Diedrich A, Hahn MK. Norepinephrine transporter variant A457P knock-in mice display key features of human postural orthostatic tachycardia syndrome. Dis Model Mech. 2013 Jul;6(4):1001-11. doi: 10.1242/dmm.012203. Epub 2013 Apr 4.
- Background: PubMed 24534443Danciu I, Cowan JD, Basford M, Wang X, Saip A, Osgood S, Shirey-Rice J, Kirby J, Harris PA. Secondary use of clinical data: the Vanderbilt approach. J Biomed Inform. 2014 Dec;52:28-35. doi: 10.1016/j.jbi.2014.02.003. Epub 2014 Feb 14.
- Individual participant dataSharing planned: No
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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.
Gordon Bernard, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Posture Study, Autonomic Function Tests, and a Stress Test in people with Chronic Fatigue Syndrome, run by Vanderbilt University Medical Center 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 25 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 26 Apr 2018. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
dihydroxyphenylglycol (DHPG)/norepinephrine (NE) Ratio (post stress) (time frame: Change from Baseline to post stress test (approximately 100 minutes post-baseline blood collection)). 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 NCT03029377, which also lists 3 linked publications.
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 26 Apr 2018.