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NCT Number: NCT05247060

Orthostatic Hypotension in Hypertensive Patient Hospitalized in Internal Medicine

The two scientific societies FADOI and SIIA have decided to start a collaborative study protocol that, through the application of a simple and homogeneous method to diagnose orthostatic hypotension, aims to estimate prevalence, conditions associates and outcomes in a cohort of patients admitted to Internal Medicine Departments and with known or newly diagnosed arterial hypertension.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale Civile, Legnano, (MI), Italy

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About this study

The IP-OP study, is an observational, multicenter, prospective, national study that provides for the involvement of 34 Operating Units of Internal Medicine, and the recording of data relating to 1000 hospitalized adults.

The clinical data of all consecutive patients diagnosed with arterial hypertension hospitalized in Internal Medicine and able to take the erect station will be collected.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years
  • Presence of arterial hypertension (known or discovered at hospitalization)
  • Signature of Informed Consent

Exclusion criteria

  • Patients unable to take the standing station for a few minutes

Treatment and study plan

no experimental intervention

Other

There will not be any experimental intervention. The study will be conducted according with normal clinical practice

Primary outcomes

  1. clinical conditions ( physiological parameters, copatologies) associated with the presence of orthostatic hypotension

    Time frame: 4 months

    Identification, through a multivariate analysis, of the clinical conditions associated with the presence of orthostatic hypotension in the population of hypertensive patients admitted to Internal Medicine

Secondary outcomes

  1. Prevalence of orthostatic hypotension

    Time frame: 4 months

    Prevalence of orthostatic hypotension among hypertensive patients admitted to Internal Medicine

  2. Gender differences in prevalence and conditions associated with orthostatic hypotension

    Time frame: 4 months

    Assessment of possible gender differences in prevalence and conditions associated with orthostatic hypotension

  3. Level of cognitive impairment of the subjects studied, and relationship with orthostatic hypotension

    Time frame: 4 months

    Evaluation in the initial visit of the level of cognitive impairment of the subjects studied, and relationship with orthostatic hypotension

  4. Relationship between orthostatic hypotension and a Fragility Index

    Time frame: 4 months

    Evaluation of the relationship between orthostatic hypotension and a Fragility Index

  5. Relationship between orthostatic hypotension and comorbidity by calculating the index of Charlson comorbidity

    Time frame: 4 months

    Evaluation of the relationship between orthostatic hypotension and comorbidity by calculating the index of Charlson comorbidity

  6. Prescription drugs on the presence and severity of hypotension Orthostatic

    Time frame: 4 months

    Analysis of the impact of prescription drugs on the presence and severity of hypotension Orthostatic

  7. Presence of orthostatic hypertension

    Time frame: 4 months

    Evaluation of the presence of orthostatic hypertension

  8. After 6-12-24-36 months from the index hospitalization, of the state of health of all the subjects evaluated

    Time frame: 6-12-24-36 months from hospitalization

    Evaluation, after 6-12-24-36 months from the index hospitalization, of the state of health of all the subjects evaluated, reporting the possible onset of falls, major cardiovascular events (stroke, TIA, myocardial infarction, arrhythmias) or death.

Sponsors and collaborators

Lead sponsor

Fadoi Foundation, Italy

Other

Registry information

Official study title

Orthostatic Hypotension in Hypertensive Patient Hospitalized in Internal Medicine - Prevalence, Concomitant Conditions and Outcomes

Acronym: IP-OP

Important dates

Study start
2018
Primary completion
2023
Study completion
2024
First posted
Feb 18, 2022
Registry last updated
Feb 28, 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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