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OpenTrials
Completed

NCT Number: NCT05304806

Effective Volemia in Older Adults With Orthostatic Hypotension

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.

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Key information

Conditions

Orthostatic Hypotension Autonomic Nervous System Diseases Cardiovascular Diseases Hypotension Hypotension, Orthostatic Nervous System Diseases Orthostatic Intolerance Primary Dysautonomias Vascular Diseases

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Geriatric medecine department, Ambroise Paré hospital, APHP

Boulogne-Billancourt, 92100, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 70 years and older
  • Orthostatic hypotension or venous insufficiency
  • Affiliated to a social security or beneficiary

Exclusion criteria

  • Refusal to participation to the study
  • Cognitive disorder
  • Unable to keep sitting posture for up to 30 minutes
  • Foreign patients under french AME scheme

Treatment and study plan

Primary outcomes

  1. Duration of recording during positional echography

    Time frame: 3 months

    Feasibility of positional echography assessed by

    • Duration of recording (minutes)

  2. 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)

Secondary outcomes

  1. Cardiac ultra sound parameters: left ventricle diastolic diameter

    Time frame: 3 months

    • Left ventricle diastolic diameter mm/m2

  2. Cardiac ultra sound parameters: left ventricle ejection fraction

    Time frame: 3 months

    • Left ventricle ejection fraction (%)

  3. Cardiac ultra sound parameters: E and A waves velocity

    Time frame: 3 months

    • E and A waves velocity (cm/sec) (mitral Doppler)

  4. Cardiac ultra sound parameters: Inferior vena cava size and compliance

    Time frame: 3 months

    • Inferior vena cava size (mm) and compliance (%)

  5. Cardiac ultra sound parameters: left atrial size

    Time frame: 3 months

    • Left atrial size (cm2)

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Effective Volemia in Older Adults With Orthostatic Hypotension, Feasibility Study

Acronym: EVO

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 31, 2022
Registry last updated
Feb 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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