Effective Volemia in Older Adults With Orthostatic Hypotension
EVO
2 other identifiers
observational
20
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2022
CompletedFirst Posted
Study publicly available on registry
March 31, 2022
CompletedStudy Start
First participant enrolled
April 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 21, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 21, 2022
CompletedFebruary 1, 2024
January 1, 2024
6 months
February 9, 2022
January 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Duration of recording during positional echography
Feasibility of positional echography assessed by \- Duration of recording (minutes)
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)
3 months
Secondary Outcomes (5)
Cardiac ultra sound parameters: left ventricle diastolic diameter
3 months
Cardiac ultra sound parameters: left ventricle ejection fraction
3 months
Cardiac ultra sound parameters: E and A waves velocity
3 months
Cardiac ultra sound parameters: Inferior vena cava size and compliance
3 months
Cardiac ultra sound parameters: left atrial size
3 months
Eligibility Criteria
Patients older than 70 years, orthostatic hypotension
You may qualify if:
- years and older
- Orthostatic hypotension or venous insufficiency
- Affiliated to a social security or beneficiary
You may not qualify if:
- Refusal to participation to the study
- Cognitive disorder
- Unable to keep sitting posture for up to 30 minutes
- Foreign patients under french AME scheme
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Geriatric medecine department, Ambroise Paré hospital, APHP
Boulogne-Billancourt, 92100, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marion Pepin, MD, PhD
Geriatric medecine department, Ambroise Paré hospital, APHP
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2022
First Posted
March 31, 2022
Study Start
April 20, 2022
Primary Completion
October 21, 2022
Study Completion
October 21, 2022
Last Updated
February 1, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share