Orthostatic IntoleranceNCT04842058
Pathophysiologic Hemodynamics After Primary Unilateral Total Hip Arthroplasty in Patients Receiving ACEIs and ARBs
An observational study of Orthostatic Intolerance and Orthostatic Hypotension, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
Incidence and pathophysiologic hemodynamics of postoperative orthostatic intolerance and orthostatic hypotension in patients receiving antihypertensives Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthostatic Intolerance, Orthostatic Hypotension
- What is being tested?
- Mobilisation procedure
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Dec 2020to 1 Dec 2023
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Patients receiving antuhypertensives (ACEIs, ARBs) and undergoing primary unilateral total hip arthroplasty in spinal anesthesia in standardized fast-track setting
Who may be able to join
- Patients undergoing primary unilateral total hip arthroplasty (THA) in spinal anaesthesia in standardized fast-track setting
- Habitual use of angiontensin-Converting Enzyme Inhibitors (ACEIs) and/or angiotensin 2 receptor blockers (ARBs) on any indication
- Patients > 18
- Patients that understand and speak Danish
- Patients that have provided written informed consent
Who cannot join
- Alcohol abuse
- Any type of substance abuse
- Chronic pain treated by habitual use of opioids
- Habitual use of anxiolytic, antidepressant and/or antipsychotic drugs
- History of cerebral apoplexy or transitory cerebral ischemia
- History of previous orthostatic intolerance or hypotension
Show all 11Show fewer
- History of diabetes mellitus
- History of following diseases of the autonomic nervous system: Parkinson disease, multiple sclerosis, multiple system atrophy, autonomic neuropathies
- Cognitive dysfunction
- Dementia
- American Society of Anesthesiologists (ASA) > 3
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Hvidovre University Hospital
Copenhagen, 2960
Ana-Marija Hristovska, 38621508, anamarijahristovska@gmail.com
Nicolai Foss
About this study
Official title: Pathophysiologic Hemodynamics After Primary Unilateral Total Hip Arthroplasty in Patients Receiving Angiotensin-Converting Enzyme Inhibitors (ACEIs) and Angiotensin II Receptor Blockers (ARBs)
Incidence and pathophysiologic hemodynamics of postoperative orthostatic intolerance and orthostatic hypotension in patients receiving antihypertensives
Read the detailed description
Early postoperative mobilization is essential for rapid functional recovery after surgery and it is considered a cornerstone in the so-called fast track multimodal perioperative approach, which includes early ambulation, oral nutrition, multimodal opioid-sparing analgesia and optimized fluid therapy. This strategy has improved patient outcome after surgery and reduced hospital length of stay. Immobilization after surgery is associated with increased risk of complications including venous thromboembolism (deep venous thrombosis, pulmonary embolism), muscle wasting, pneumonia and atelectasis, thereby impending convalescence.
However, early postoperative mobilization can be delayed due to failed orthostatic cardiovascular regulation, resulting in postoperative orthostatic hypotension (OH), defined as a decrease in systolic blood pressure > 20 mmHg or diastolic blood pressure > 10 mmHg or postoperative orthostatic intolerance (OI), characterized by dizziness, nausea, vomiting, visual disturbances or syncope.
Previous studies investigating the incidence and pathophysiology of postoperative OI and OH included mixed patient populations. Hitherto no studies have been performed looking into the incidence and pathophysiologic hemodynamics of postoperative OI and OH specifically in patients receiving angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin II receptor blockers (ARBs), antihypertensive agents with potential effects on cardiovascular compensatory functions.
The current study aims therefore to estimate the incidence and gain knowledge on pathophysiological hemodynamics of postoperative OI and OH in patients receiving ACEIs and ARBs.
- Conditions
- Orthostatic Intolerance, Orthostatic Hypotension
- Being tested
- Mobilisation procedure
- Keywords
- Orthostatic Hypotension, Orthostatic Intolerance, Postoperative period, Antihypertensives, Autonomic dysfunction
- Medical subject headings
- Orthostatic Intolerance, Hypotension, Orthostatic, Primary Dysautonomias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobilisation procedureOther
A standardized mobilization procedure was performed preoperatively ~ 1h before surgery and was repeated 6h and 24h after surgery. The mobilization procedure included patient supine rest (5 minutes), followed by 45° passive leg raise (PLR) (3 minutes), supine rest (5 minutes), sitting on the edge of the bed with feet resting on the floor (3 minutes) followed by standing using a walker while the patient was encouraged verbally to stand on toes and shift body weight from one leg to the other (3 minutes) and finally rest in supine position (5 minutes). The procedure was terminated prematurely in any position if patients experienced unbearable symptoms of OI or upon a decrease of systolic arterial pressure (SAP) > 30 mmHg.
| Study group | Role | What they receive |
|---|---|---|
| Orthostatic tolerant patients (OT) | Patients that experience symptoms of orthostatic intolerance (dizziness, nausea, vomiting, blurry vision or syncope) or orthostatic hypotension (fall in systolic pressure > 20 mmHg and/or diastolic pressure > 10 mmHg) during mobilisation Receives: Other: Mobilisation procedure | |
| Orthostatic intolerant patients (OI) | Patients that do not experience symptoms of orthostatic intolerance (dizziness, nausea, vomiting, blurry vision or syncope) or orthostatic hypotension (fall in systolic pressure > 20 mmHg and/or diastolic pressure > 10 mmHg) during mobilisation Receives: Other: Mobilisation procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of orthostatic intolerance
Symptoms of orthostatic intolerance: dizziness, nausea, vomiting, blurry vision or syncope during mobilization
Measured: 6 hours postoperatively
Incidence of orthostatic hypotension
Orthostatic hypotension is defined as a fall in systolic pressure > 20 mmHg and/or diastolic pressure > 10 mmHg during mobilization
Measured: 6 hours postoperatively
Secondary outcomes (31)
Changes in systolic arterial pressure (SAP) during mobilization
Measured in mmHg by non-invasive Lithium Dilution Cardiac Output (LiDCO) measurement
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in diastolic arterial pressure (DAP) during mobilization
Measured in mmHg by non-invasive LiDCO
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in mean arterial pressure (MAP) during mobilization
Measured in mmHg by non-invasive LiDCO
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in systemic vascular resistance (SVR) during mobilization
Measured in dynes s cm-5 by non-invasive LiDCO
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in cardiac output (CO) during mobilization
Measured in L/min by non-invasive LiDCO
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in stroke volume (SV) during mobilization
Measured in mL by non-invasive LiDCO
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in heart rate (HR) during mobilization
Measured in beats min-1 by non-invasive LiDCO
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in pulse pressure (PP) during mobilization
Measured in mmHg
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in cerebral perfusion (ScO2) during mobilization
Measured in % by Root Masimo
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in muscular perfusion (SmO2) during mobilization
Measured in % by Root Masimo
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in peripheral perfusion index (PPI) during mobilization
Measured in % by Root Masimo
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in total blood volume (TBV)
Measured in mL by Carbon Monoxide - rebreathing technique
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in red blood cell volume (RBCV)
Measured in mL by Carbon Monoxide - rebreathing technique
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in plasma volume (PV)
Measured in mL by Carbon Monoxide - rebreathing technique
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in hematocrit
Measured in %
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in total mass of hemoglobin
Measured in grams
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in hemoglobin concentration
Measured in gr/L
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in C-Reactive Protein
Measured in mg/L
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in heart rate variability (HRV) during Valsalva manoeuvre
Measured in ms
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in baroreflex sensitivity - vagal (BRSv) during Valsalva manoeuvre
Measured in ms
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in Valsalva ratio (VR) during Valsalva manoeuvre
Measured as index
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in Systolic Sympathetic Index 1 (SSI1) during Valsalva manoeuvre
Measured as index
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in Systolic Sympathetic Index 2 (SSI2) during Valsalva manoeuvre
Measured as index
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in Systolic Sympathetic Index 3 (SSI3) during Valsalva manoeuvre
Measured as index
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in Diastolic Sympathetic Index 1 (DSI1) during Valsalva manoeuvre
Measured as index
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in Diastolic Sympathetic Index 2 (DSI2) during Valsalva manoeuvre
Measured as index
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in Diastolic Sympathetic Index 3 (DSI3) during Valsalva manoeuvre
Measured as index
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in Pressure Recovery Time (PRT) during Valsalva manoeuvre
Measured in seconds
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in Baroreceptor Reflex Sensitivity-adrenergic (BRS-a) during Valsalva manoeuvre
Measured in seconds
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in systolic latency during Valsalva manoeuvre
Measured in seconds
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in diastolic latency during Valsalva manoeuvre
Measured in seconds
Measured: Preoperatively, 6 and 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start1 Dec 2020
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Orthostatic IntoleranceStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kehlet, Henrik, M.D., Ph.D.
- Responsible party
- Principal investigator, Ana-Marija Hristovska, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04842058
- Sponsor's protocol ID
- H-20017723
- Status last verified
- Apr 2021
- First submitted
- 8 Apr 2021
- Last updated
- 12 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jans O, Bundgaard-Nielsen M, Solgaard S, Johansson PI, Kehlet H. Orthostatic intolerance during early mobilization after fast-track hip arthroplasty. Br J Anaesth. 2012 Mar;108(3):436-43. doi: 10.1093/bja/aer403. Epub 2011 Dec 15.
PubMed 22174345Jans O, Kehlet H. Postoperative orthostatic intolerance: a common perioperative problem with few available solutions. Can J Anaesth. 2017 Jan;64(1):10-15. doi: 10.1007/s12630-016-0734-7. Epub 2016 Sep 14. No abstract available.
PubMed 27638295
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathophysiologic Hemodynamics After Primary Unilateral Total Hip Arthroplasty in Patients Receiving Angiotensin-Converting Enzyme Inhibitors (ACEIs) and Angiotensin II Receptor Blockers (ARBs)
- ClinicalTrials.gov ID
- NCT04842058
- Acronym / sponsor ID
- H-20017723
- Conditions
- Orthostatic Intolerance, Orthostatic Hypotension
- Keywords
- Orthostatic Hypotension, Orthostatic Intolerance, Postoperative period, Antihypertensives, Autonomic dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Kehlet, Henrik, M.D., Ph.D.
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 12 Apr 2021 (actual)
- 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.
Incidence and pathophysiologic hemodynamics of postoperative orthostatic intolerance and orthostatic hypotension in patients receiving antihypertensives
Detailed description
Early postoperative mobilization is essential for rapid functional recovery after surgery and it is considered a cornerstone in the so-called fast track multimodal perioperative approach, which includes early ambulation, oral nutrition, multimodal opioid-sparing analgesia and optimized fluid therapy. This strategy has improved patient outcome after surgery and reduced hospital length of stay. Immobilization after surgery is associated with increased risk of complications including venous thromboembolism (deep venous thrombosis, pulmonary embolism), muscle wasting, pneumonia and atelectasis, thereby impending convalescence.
However, early postoperative mobilization can be delayed due to failed orthostatic cardiovascular regulation, resulting in postoperative orthostatic hypotension (OH), defined as a decrease in systolic blood pressure > 20 mmHg or diastolic blood pressure > 10 mmHg or postoperative orthostatic intolerance (OI), characterized by dizziness, nausea, vomiting, visual disturbances or syncope.
Previous studies investigating the incidence and pathophysiology of postoperative OI and OH included mixed patient populations. Hitherto no studies have been performed looking into the incidence and pathophysiologic hemodynamics of postoperative OI and OH specifically in patients receiving angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin II receptor blockers (ARBs), antihypertensive agents with potential effects on cardiovascular compensatory functions.
The current study aims therefore to estimate the incidence and gain knowledge on pathophysiological hemodynamics of postoperative OI and OH in patients receiving ACEIs and ARBs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orthostatic tolerant patients (OT) | – | Other: Mobilisation procedurePatients that experience symptoms of orthostatic intolerance (dizziness, nausea, vomiting, blurry vision or syncope) or orthostatic hypotension (fall in systolic pressure > 20 mmHg and/or diastolic pressure > 10 mmHg) during mobilisation |
| Orthostatic intolerant patients (OI) | – | Other: Mobilisation procedurePatients that do not experience symptoms of orthostatic intolerance (dizziness, nausea, vomiting, blurry vision or syncope) or orthostatic hypotension (fall in systolic pressure > 20 mmHg and/or diastolic pressure > 10 mmHg) during mobilisation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients receiving antuhypertensives (ACEIs, ARBs) and undergoing primary unilateral total hip arthroplasty in spinal anesthesia in standardized fast-track setting
Key inclusion criteria (5 listed)
- Patients undergoing primary unilateral total hip arthroplasty (THA) in spinal anaesthesia in standardized fast-track setting
- Habitual use of angiontensin-Converting Enzyme Inhibitors (ACEIs) and/or angiotensin 2 receptor blockers (ARBs) on any indication
- Patients > 18
- Patients that understand and speak Danish
- Patients that have provided written informed consent
Key exclusion criteria (11 listed)
- Alcohol abuse
- Any type of substance abuse
- Chronic pain treated by habitual use of opioids
- Habitual use of anxiolytic, antidepressant and/or antipsychotic drugs
- History of cerebral apoplexy or transitory cerebral ischemia
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 |
|---|---|---|
| Mobilisation procedureA standardized mobilization procedure was performed preoperatively ~ 1h before surgery and was repeated 6h and 24h after surgery. The mobilization procedure included patient supine rest (5 minutes), followed by 45° passive leg raise (PLR) (3 minutes), supine rest (5 minutes), sitting on the edge of the bed with feet resting on the floor (3 minutes) followed by standing using a walker while the patient was encouraged verbally to stand on toes and shift body weight from one leg to the other (3 minutes) and finally rest in supine position (5 minutes). The procedure was terminated prematurely in any position if patients experienced unbearable symptoms of OI or upon a decrease of systolic arterial pressure (SAP) > 30 mmHg. | Other | Orthostatic intolerant patients (OI), Orthostatic tolerant patients (OT) |
Primary outcome
Incidence of orthostatic intolerance
Time frame: 6 hours postoperatively
Symptoms of orthostatic intolerance: dizziness, nausea, vomiting, blurry vision or syncope during mobilization
Incidence of orthostatic hypotension
Time frame: 6 hours postoperatively
Orthostatic hypotension is defined as a fall in systolic pressure > 20 mmHg and/or diastolic pressure > 10 mmHg during mobilization
31 secondary outcomes
Changes in systolic arterial pressure (SAP) during mobilization
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in diastolic arterial pressure (DAP) during mobilization
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in mean arterial pressure (MAP) during mobilization
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in systemic vascular resistance (SVR) during mobilization
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in cardiac output (CO) during mobilization
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in stroke volume (SV) during mobilization
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in heart rate (HR) during mobilization
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in pulse pressure (PP) during mobilization
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in cerebral perfusion (ScO2) during mobilization
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in muscular perfusion (SmO2) during mobilization
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in peripheral perfusion index (PPI) during mobilization
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in total blood volume (TBV)
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in red blood cell volume (RBCV)
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in plasma volume (PV)
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in hematocrit
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in total mass of hemoglobin
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in hemoglobin concentration
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in C-Reactive Protein
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in heart rate variability (HRV) during Valsalva manoeuvre
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in baroreflex sensitivity - vagal (BRSv) during Valsalva manoeuvre
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in Valsalva ratio (VR) during Valsalva manoeuvre
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in Systolic Sympathetic Index 1 (SSI1) during Valsalva manoeuvre
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in Systolic Sympathetic Index 2 (SSI2) during Valsalva manoeuvre
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in Systolic Sympathetic Index 3 (SSI3) during Valsalva manoeuvre
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in Diastolic Sympathetic Index 1 (DSI1) during Valsalva manoeuvre
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in Diastolic Sympathetic Index 2 (DSI2) during Valsalva manoeuvre
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in Diastolic Sympathetic Index 3 (DSI3) during Valsalva manoeuvre
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in Pressure Recovery Time (PRT) during Valsalva manoeuvre
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in Baroreceptor Reflex Sensitivity-adrenergic (BRS-a) during Valsalva manoeuvre
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in systolic latency during Valsalva manoeuvre
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in diastolic latency during Valsalva manoeuvre
Time frame: Preoperatively, 6 and 24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2021.
- Background: PubMed 22174345Jans O, Bundgaard-Nielsen M, Solgaard S, Johansson PI, Kehlet H. Orthostatic intolerance during early mobilization after fast-track hip arthroplasty. Br J Anaesth. 2012 Mar;108(3):436-43. doi: 10.1093/bja/aer403. Epub 2011 Dec 15.
- Background: PubMed 27638295Jans O, Kehlet H. Postoperative orthostatic intolerance: a common perioperative problem with few available solutions. Can J Anaesth. 2017 Jan;64(1):10-15. doi: 10.1007/s12630-016-0734-7. Epub 2016 Sep 14. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Orthostatic Intolerance
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Active, not recruitingObservational study
Adverse Events During Physical Therapy in Neurocritical ICU Patients
Critical Illness, Brain Injury
Recruiting
Ultrasound Guided Stellate Ganglion Block in Postural Tachycardia Syndrome
Postural Tachycardia Syndrome
Enrolling by invitationObservational study
Presentation of Young Adults With and Without Joint Hypermobility
Hypermobile Ehlers-Danlos Syndrome, Postural Orthostatic Tachycardia Syndrome (POTS)
Active, not recruitingObservational study
POTS NET mRNA Functional Correlation With NET Activity
Postural Tachycardia Syndrome
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthostatic Intolerance and Orthostatic Hypotension, run by Hvidovre University Hospital at 1 site in Denmark.
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 5 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 12 Apr 2021. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of orthostatic intolerance (time frame: 6 hours postoperatively). The study lists 2 primary outcomes in all. 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 NCT04842058, which also lists 2 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 12 Apr 2021.