Clinical trial NCT05247060: Orthostatic Hypotension in Hypertensive Patient Hospitalized in Internal Medicine
Official title: Orthostatic Hypotension in Hypertensive Patient Hospitalized in Internal Medicine - Prevalence, Concomitant Conditions and Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hospitalization
Keywords: orthostatic hypotension
Internal Medicine
Lead sponsor: Fadoi Foundation, Italy
Sponsor class: OTHER
First posted: 2022-02-18
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients diagnosed with arterial hypertension hospitalized in Internal Medicine and able to assume the erect station

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: clinical conditions ( physiological parameters, copatologies) associated with the presence of orthostatic hypotension
timeFrame: 4 months
Secondary outcomes:
measure: Prevalence of orthostatic hypotension
timeFrame: 4 months
measure: Gender differences in prevalence and conditions associated with orthostatic hypotension
timeFrame: 4 months
measure: Level of cognitive impairment of the subjects studied, and relationship with orthostatic hypotension
timeFrame: 4 months
measure: Relationship between orthostatic hypotension and a Fragility Index
timeFrame: 4 months
measure: Relationship between orthostatic hypotension and comorbidity by calculating the index of Charlson comorbidity
timeFrame: 4 months
measure: Prescription drugs on the presence and severity of hypotension Orthostatic
timeFrame: 4 months
measure: Presence of orthostatic hypertension
timeFrame: 4 months
measure: After 6-12-24-36 months from the index hospitalization, of the state of health of all the subjects evaluated
timeFrame: 6-12-24-36 months from hospitalization
Other outcomes:
Locations:
city: Legnano
country: Italy
facility: Ospedale Civile
state: (mi)
city: Borgo Val di Taro
country: Italy
facility: Ospedale "S. Maria"
state: (pr)
city: Luino
country: Italy
facility: Ospedale Luini Confalonieri
state: (va)
city: Bassano Del Grappa
country: Italy
facility: P.O. di Rete Bassano
state: (vi)
city: Avezzano
country: Italy
facility: P.O. "SS. Filippo e Nicola"
state: AQ
city: Cava Dè Tirreni
country: Italy
facility: Ospedale Civ. "S. Maria Incoronata dell'Olmo"
state: SA
city: Chieri
country: Italy
facility: Ospedale Maggiore
state: TO
city: Benevento
country: Italy
facility: Ospedale di Sant'Agata dei Goti
city: Brescia
country: Italy
facility: Ospedali Civili di Brescia
city: Caserta
country: Italy
facility: AO Sant'Anna e San Sebastiano
city: Catania
country: Italy
facility: Ospedale ARNAS Garibaldi
city: Como
country: Italy
facility: Ospedale Sant'Anna
city: Cuneo
country: Italy
facility: Ospedale di Ceva
city: Firenze
country: Italy
facility: AOU Careggi
city: Genova
country: Italy
facility: Ospedale di Galliera
city: L'Aquila
country: Italy
facility: Ospedale San Salvatore
city: Milano
country: Italy
facility: Ospedale Niguarda
city: Milano
country: Italy
facility: Ospedale San Luca
city: Napoli
country: Italy
facility: Ospedale Buon Consiglio Fatebenefratelli
city: Napoli
country: Italy
facility: Ospedale Cardarelli
city: Padova
country: Italy
facility: Ospedale di Piove di Sacco
city: Pistoia
country: Italy
facility: Ospedale San Jacopo
city: Pozzuoli
country: Italy
facility: P.O. "S. Maria delle Grazie"
city: Roma
country: Italy
facility: Ospedale Fatebenefratelli
city: Rovigo
country: Italy
facility: Ospedale Santa Maria della Misericordia
city: Salerno
country: Italy
facility: AOU San Giovanni di Dio e Ruggi d'Aragona
city: Siena
country: Italy
facility: Ospedale Abbadia San Salvatore
city: Siracusa
country: Italy
facility: PO "Umberto I"
city: Torino
country: Italy
facility: Ospedale "Città della Salute"
city: Treviso
country: Italy
facility: Ospedale Cà Foncello
city: Varese
country: Italy
facility: Ospedale di Circolo
city: Verona
country: Italy
facility: AOUI - Borgo Trento
city: Viareggio
country: Italy
facility: Ospedale Versilia
Study officials:
affiliation: FADOI FOUNDATION
name: Andrea Fontanella, MD
role: STUDY_DIRECTOR
References: