Orthostatic Hypotension in Hypertensive Patient Hospitalized in Internal Medicine (IP-OP)

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

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.

Study Overview

• Status: Completed
• Conditions: Hospitalization
• Intervention / Treatment: Other: no experimental intervention

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.

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

• Study Contact: Name: Antonella Valerio, PhD; Phone Number: +393456645907; Email: antonella.valerio@fadoi.org
• Study Contact Backup: Name: Claudio Ferri, Prof.; Phone Number: +393336006398; Email: claudio.ferri@univaq.it

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; There will not be any experimental intervention. The study will be conducted according with normal clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of orthostatic hypotension	Prevalence of orthostatic hypotension among hypertensive patients admitted to Internal Medicine	4 months
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
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
Relationship between orthostatic hypotension and a Fragility Index	Evaluation of the relationship between orthostatic hypotension and a Fragility Index	4 months
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
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
Presence of orthostatic hypertension	Evaluation of the presence of orthostatic hypertension	4 months
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

Collaborators and Investigators

• Sponsor: Fadoi Foundation, Italy
• Investigators: Study Director: Andrea Fontanella, MD, FADOI FOUNDATION

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2018
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): February 20, 2024

Study Registration Dates

• First Submitted: February 9, 2022
• First Submitted That Met QC Criteria: February 9, 2022
• First Posted (Actual): February 18, 2022

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: orthostatic hypotension; Internal Medicine
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Autonomic Nervous System Diseases; Primary Dysautonomias; Orthostatic Intolerance; Hypotension; Hypotension, Orthostatic
• Other Study ID Numbers: FADOI.02.2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No