Orthostatic HypotensionEVONCT05304806
Effective Volemia in Older Adults With Orthostatic Hypotension
An observational study of Orthostatic Hypotension, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Clinical and biological assessments of volemia are challenging in older patients as they are more likely to present non-typical signs. Point of care ultrasonography (POCUS) using heart and lung exploration is a relevant tool to assess volemia in adults with little data in older adults. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Orthostatic Hypotension
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 20 Apr 2022to 21 Oct 2022
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients older than 70 years, orthostatic hypotension
Who may be able to join
- 70 years and older
- Orthostatic hypotension or venous insufficiency
- Affiliated to a social security or beneficiary
Who cannot join
- Refusal to participation to the study
- Cognitive disorder
- Unable to keep sitting posture for up to 30 minutes
- Foreign patients under french AME scheme
Trial locations and contacts
1 site in 1 country.
France1 site
Geriatric medecine department, Ambroise Paré hospital, APHP
Boulogne-Billancourt, 92100
About this study
Official title: Effective Volemia in Older Adults With Orthostatic Hypotension, Feasibility Study
Clinical and biological assessments of volemia are challenging in older patients as they are more likely to present non-typical signs. Point of care ultrasonography (POCUS) using heart and lung exploration is a relevant tool to assess volemia in adults with little data in older adults.
The primary objective of the study is to evaluate feasibility of positional POCUS in aging patients.
The secondary objectives are to assess the variability of measurements between decubitus and sitting position.
Read the detailed description
This is a monocentric study. Twenty patients will be enrolled, aged of 70 years and older. POCUS parameters, duration of procedure and measurements will be recorded for each patients.
- Conditions
- Orthostatic Hypotension
- Keywords
- older, orthostatic hypotension, volemia, clinical sonography
- Medical subject headings
- Hypotension, Orthostatic
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of recording during positional echography
Feasibility of positional echography assessed by
- Duration of recording (minutes)
Measured: 3 months
Feasibility of positional echography
Feasibility of positional echography assessed by
- Number of good quality imaging (out of 5 pre specified views : parasternal long axis view, parasternal short axis view, apical views 4 and 5 chamber, subxiphoid view, inferior vena cava view)
Measured: 3 months
Secondary outcomes (5)
Cardiac ultra sound parameters: left ventricle diastolic diameter
- Left ventricle diastolic diameter mm/m2
Measured: 3 months
Cardiac ultra sound parameters: left ventricle ejection fraction
- Left ventricle ejection fraction (%)
Measured: 3 months
Cardiac ultra sound parameters: E and A waves velocity
- E and A waves velocity (cm/sec) (mitral Doppler)
Measured: 3 months
Cardiac ultra sound parameters: Inferior vena cava size and compliance
- Inferior vena cava size (mm) and compliance (%)
Measured: 3 months
Cardiac ultra sound parameters: left atrial size
- Left atrial size (cm2)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start20 Apr 2022
- Primary completion21 Oct 2022
- Study completion21 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthostatic HypotensionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marion Pepin, MD, PhD, Principal investigator, Geriatric medecine department, Ambroise Paré hospital, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05304806
- Sponsor's protocol ID
- APHP220078
- Other IDs
- 2021-A03112-39
- Acronym
- EVO
- Status last verified
- Jan 2024
- First submitted
- 9 Feb 2022
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective Volemia in Older Adults With Orthostatic Hypotension, Feasibility Study
- ClinicalTrials.gov ID
- NCT05304806
- Acronym / sponsor ID
- EVO / APHP220078
- Conditions
- Orthostatic Hypotension
- Keywords
- older, orthostatic hypotension, volemia, clinical sonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 21 Oct 2022 (actual)
- Study completion
- 21 Oct 2022 (actual)
- First posted
- 31 Mar 2022 (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.
Clinical and biological assessments of volemia are challenging in older patients as they are more likely to present non-typical signs. Point of care ultrasonography (POCUS) using heart and lung exploration is a relevant tool to assess volemia in adults with little data in older adults.
The primary objective of the study is to evaluate feasibility of positional POCUS in aging patients.
The secondary objectives are to assess the variability of measurements between decubitus and sitting position.
Detailed description
This is a monocentric study. Twenty patients will be enrolled, aged of 70 years and older. POCUS parameters, duration of procedure and measurements will be recorded for each patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients older than 70 years, orthostatic hypotension
Key inclusion criteria (3 listed)
- 70 years and older
- Orthostatic hypotension or venous insufficiency
- Affiliated to a social security or beneficiary
Key exclusion criteria (4 listed)
- Refusal to participation to the study
- Cognitive disorder
- Unable to keep sitting posture for up to 30 minutes
- Foreign patients under french AME scheme
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Duration of recording during positional echography
Time frame: 3 months
Feasibility of positional echography assessed by - Duration of recording (minutes)
Feasibility of positional echography
Time frame: 3 months
Feasibility of positional echography assessed by - Number of good quality imaging (out of 5 pre specified views : parasternal long axis view, parasternal short axis view, apical views 4 and 5 chamber, subxiphoid view, inferior vena cava view)
5 secondary outcomes
Cardiac ultra sound parameters: left ventricle diastolic diameter
Time frame: 3 months
Cardiac ultra sound parameters: left ventricle ejection fraction
Time frame: 3 months
Cardiac ultra sound parameters: E and A waves velocity
Time frame: 3 months
Cardiac ultra sound parameters: Inferior vena cava size and compliance
Time frame: 3 months
Cardiac ultra sound parameters: left atrial size
Time frame: 3 months
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 1 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Orthostatic Hypotension
Active, not recruitingPhase 2
A Study in Subjects With Neurogenic Orthostatic Hypotension
Neurogenic Orthostatic Hypotension
Active, not recruiting
Water and the Gastropressor Response - Tachyphylaxis
Orthostatic Hypotension
Active, not recruiting
Water and the Gastropressor Response - Diurnal Variability
Orthostatic Hypotension
Not yet recruiting
Spinal Cord Stimulation for Neurogenic Orthostatic Hypotension
Neurogenic Orthostatic Hypotension
RecruitingObservational study
Fainting Detection And Early Warning In Syncope Evaluation Study (ARISE)
Orthostatic Hypotension, Reflex Syncope
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.
Marion Pepin, MD, PhD principal investigator
Geriatric medecine department, Ambroise Paré hospital, APHP
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 Hypotension, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 3 inclusion and 4 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 1 Feb 2024. 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 France. 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?
Duration of recording during positional echography (time frame: 3 months). 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?
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 1 Feb 2024.