NCT05247060

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Longer than P75 for all trials

Geographic Reach
1 country

33 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 16, 2018

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 18, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2024

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

4.7 years

First QC Date

February 9, 2022

Last Update Submit

February 27, 2024

Conditions

Keywords

orthostatic hypotensionInternal Medicine

Outcome Measures

Primary Outcomes (1)

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

    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

    4 months

Secondary Outcomes (8)

  • Prevalence of orthostatic hypotension

    4 months

  • Gender differences in prevalence and conditions associated with orthostatic hypotension

    4 months

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

    4 months

  • Relationship between orthostatic hypotension and a Fragility Index

    4 months

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

    4 months

  • +3 more secondary outcomes

Study Arms (1)

Hypertensive Patients Hospitalized in Internal Medicine

Clinical data will be collected from all consecutive patients diagnosed with arterial hypertension hospitalized in Internal Medicine and able to assume the erect station

Other: no experimental intervention

Interventions

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

Hypertensive Patients Hospitalized in Internal Medicine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Consecutive patients diagnosed with arterial hypertension hospitalized in Internal Medicine and able to assume the erect station

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (33)

Ospedale Civile

Legnano, (MI), Italy

Location

Ospedale "S. Maria"

Borgo Val di Taro, (PR), Italy

Location

Ospedale Luini Confalonieri

Luino, (VA), Italy

Location

P.O. di Rete Bassano

Bassano del Grappa, (VI), Italy

Location

P.O. "SS. Filippo e Nicola"

Avezzano, AQ, Italy

Location

Ospedale Civ. "S. Maria Incoronata dell'Olmo"

Cava de' Tirreni, SA, Italy

Location

Ospedale Maggiore

Chieri, TO, Italy

Location

Ospedale di Sant'Agata dei Goti

Benevento, Italy

Location

Ospedali Civili di Brescia

Brescia, Italy

Location

AO Sant'Anna e San Sebastiano

Caserta, Italy

Location

Ospedale ARNAS Garibaldi

Catania, Italy

Location

Ospedale Sant'Anna

Como, Italy

Location

Ospedale di Ceva

Cuneo, Italy

Location

AOU Careggi

Florence, Italy

Location

Ospedale di Galliera

Genova, Italy

Location

Ospedale San Salvatore

L’Aquila, Italy

Location

Ospedale Niguarda

Milan, Italy

Location

Ospedale San Luca

Milan, Italy

Location

Ospedale Buon Consiglio Fatebenefratelli

Napoli, Italy

Location

Ospedale Cardarelli

Napoli, Italy

Location

Ospedale di Piove di Sacco

Padua, Italy

Location

Ospedale San Jacopo

Pistoia, Italy

Location

P.O. "S. Maria delle Grazie"

Pozzuoli, Italy

Location

Ospedale Fatebenefratelli

Roma, Italy

Location

Ospedale Santa Maria della Misericordia

Rovigo, Italy

Location

AOU San Giovanni di Dio e Ruggi d'Aragona

Salerno, Italy

Location

Ospedale Abbadia San Salvatore

Siena, Italy

Location

PO "Umberto I"

Syracuse, Italy

Location

Ospedale "Città della Salute"

Torino, Italy

Location

Ospedale Cà Foncello

Treviso, Italy

Location

Ospedale di Circolo

Varese, Italy

Location

AOUI - Borgo Trento

Verona, Italy

Location

Ospedale Versilia

Viareggio, Italy

Location

MeSH Terms

Conditions

Hypotension, Orthostatic

Condition Hierarchy (Ancestors)

Orthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesHypotensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Andrea Fontanella, MD

    FADOI FOUNDATION

    STUDY DIRECTOR

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

February 18, 2022

Study Start

October 16, 2018

Primary Completion

June 30, 2023

Study Completion

February 20, 2024

Last Updated

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations