Orthostatic Hypotension in Hypertensive Patient Hospitalized in Internal Medicine

Hospitalization Clinical Trial

— IP-OP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05247060
• Other study ID #: FADOI.02.2018
• Status: Completed
• Start date: October 16, 2018
• Est. completion date: February 20, 2024

Study information

• Verified date: February 2024
• Source: Fadoi Foundation, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: February 20, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hospitalization
• Hypotension
• Hypotension, Orthostatic

Intervention

Other:
• no experimental intervention
There will not be any experimental intervention. The study will be conducted according with normal clinical practice

Locations

Country	Name	City	State
Italy	P.O. "SS. Filippo e Nicola"	Avezzano	AQ
Italy	P.O. di Rete Bassano	Bassano Del Grappa	(vi)
Italy	Ospedale di Sant'Agata dei Goti	Benevento
Italy	Ospedale "S. Maria"	Borgo Val di Taro	(pr)
Italy	Ospedali Civili di Brescia	Brescia
Italy	AO Sant'Anna e San Sebastiano	Caserta
Italy	Ospedale ARNAS Garibaldi	Catania
Italy	Ospedale Civ. "S. Maria Incoronata dell'Olmo"	Cava Dè Tirreni	SA
Italy	Ospedale Maggiore	Chieri	TO
Italy	Ospedale Sant'Anna	Como
Italy	Ospedale di Ceva	Cuneo
Italy	AOU Careggi	Firenze
Italy	Ospedale di Galliera	Genova
Italy	Ospedale San Salvatore	L'Aquila
Italy	Ospedale Civile	Legnano	(mi)
Italy	Ospedale Luini Confalonieri	Luino	(va)
Italy	Ospedale Niguarda	Milano
Italy	Ospedale San Luca	Milano
Italy	Ospedale Buon Consiglio Fatebenefratelli	Napoli
Italy	Ospedale Cardarelli	Napoli
Italy	Ospedale di Piove di Sacco	Padova
Italy	Ospedale San Jacopo	Pistoia
Italy	P.O. "S. Maria delle Grazie"	Pozzuoli
Italy	Ospedale Fatebenefratelli	Roma
Italy	Ospedale Santa Maria della Misericordia	Rovigo
Italy	AOU San Giovanni di Dio e Ruggi d'Aragona	Salerno
Italy	Ospedale Abbadia San Salvatore	Siena
Italy	PO "Umberto I"	Siracusa
Italy	Ospedale "Città della Salute"	Torino
Italy	Ospedale Cà Foncello	Treviso
Italy	Ospedale di Circolo	Varese
Italy	AOUI - Borgo Trento	Verona
Italy	Ospedale Versilia	Viareggio

Sponsors (1)

Lead Sponsor	Collaborator
Fadoi Foundation, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Prevalence of orthostatic hypotension	Prevalence of orthostatic hypotension among hypertensive patients admitted to Internal Medicine	4 months
Secondary	Gender differences in prevalence and conditions associated with orthostatic hypotension	Assessment of possible gender differences in prevalence and conditions associated with orthostatic hypotension	4 months
Secondary	Level of cognitive impairment of the subjects studied, and relationship with orthostatic hypotension	Evaluation in the initial visit of the level of cognitive impairment of the subjects studied, and relationship with orthostatic hypotension	4 months
Secondary	Relationship between orthostatic hypotension and a Fragility Index	Evaluation of the relationship between orthostatic hypotension and a Fragility Index	4 months
Secondary	Relationship between orthostatic hypotension and comorbidity by calculating the index of Charlson comorbidity	Evaluation of the relationship between orthostatic hypotension and comorbidity by calculating the index of Charlson comorbidity	4 months
Secondary	Prescription drugs on the presence and severity of hypotension Orthostatic	Analysis of the impact of prescription drugs on the presence and severity of hypotension Orthostatic	4 months
Secondary	Presence of orthostatic hypertension	Evaluation of the presence of orthostatic hypertension	4 months
Secondary	After 6-12-24-36 months from the index hospitalization, of the state of health of all the subjects evaluated	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.	6-12-24-36 months from hospitalization