HospitalizationIP-OPNCT05247060
Orthostatic Hypotension in Hypertensive Patient Hospitalized in Internal Medicine
An observational study of Hospitalization, run by Fadoi Foundation, Italy at 33 sites in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hospitalization
- What is being tested?
- no experimental intervention
- How many people
- 1,000 participants
- Where
- 33 sitesItaly
- Study dates
- 16 Oct 2018to 20 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients diagnosed with arterial hypertension hospitalized in Internal Medicine and able to assume the erect station
Who may be able to join
- Age ≥ 18 years
- Presence of arterial hypertension (known or discovered at hospitalization)
- Signature of Informed Consent
Who cannot join
- Patients unable to take the standing station for a few minutes
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
Italy33 sites
P.O. "SS. Filippo e Nicola"
Avezzano, AQ
P.O. di Rete Bassano
Bassano del Grappa, (VI)
Ospedale di Sant'Agata dei Goti
Benevento
Ospedale "S. Maria"
Borgo Val di Taro, (PR)
Ospedali Civili di Brescia
Brescia
AO Sant'Anna e San Sebastiano
Caserta
Ospedale ARNAS Garibaldi
Catania
Ospedale Civ. "S. Maria Incoronata dell'Olmo"
Cava de' Tirreni, SA
Ospedale Maggiore
Chieri, TO
Ospedale Sant'Anna
Como
Ospedale di Ceva
Cuneo
AOU Careggi
Florence
Ospedale di Galliera
Genova
Ospedale San Salvatore
L’Aquila
Ospedale Civile
Legnano, (MI)
Ospedale Luini Confalonieri
Luino, (VA)
Ospedale Niguarda
Milan
Ospedale San Luca
Milan
Ospedale Buon Consiglio Fatebenefratelli
Naples
Ospedale Cardarelli
Naples
Ospedale di Piove di Sacco
Padova
Ospedale San Jacopo
Pistoia
P.O. "S. Maria delle Grazie"
Pozzuoli
Ospedale Fatebenefratelli
Roma
Ospedale Santa Maria della Misericordia
Rovigo
AOU San Giovanni di Dio e Ruggi d'Aragona
Salerno
Ospedale Abbadia San Salvatore
Siena
PO "Umberto I"
Syracuse
Ospedale "Città della Salute"
Torino
Ospedale Cà Foncello
Treviso
Ospedale di Circolo
Varese
AOUI - Borgo Trento
Verona
Ospedale Versilia
Viareggio
About this study
Official title: 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.
Read the 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.
- Conditions
- Hospitalization
- Being tested
- no experimental intervention
- Keywords
- orthostatic hypotension, Internal Medicine
- Medical subject headings
- Hypotension, Orthostatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no experimental interventionOther
There will not be any experimental intervention. The study will be conducted according with normal clinical practice
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: no experimental intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 months
Secondary outcomes (8)
Prevalence of orthostatic hypotension
Prevalence of orthostatic hypotension among hypertensive patients admitted to Internal Medicine
Measured: 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
Measured: 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
Measured: 4 months
Relationship between orthostatic hypotension and a Fragility Index
Evaluation of the relationship between orthostatic hypotension and a Fragility Index
Measured: 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
Measured: 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
Measured: 4 months
Presence of orthostatic hypertension
Evaluation of the presence of orthostatic hypertension
Measured: 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.
Measured: 6-12-24-36 months from hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start16 Oct 2018
- Primary completion30 Jun 2023
- Study completion20 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HospitalizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fadoi Foundation, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Fontanella, MD, Study director, FADOI FOUNDATION
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247060
- Sponsor's protocol ID
- FADOI.02.2018
- Acronym
- IP-OP
- Status last verified
- Feb 2024
- First submitted
- 9 Feb 2022
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ferri C, Mazza A, Manfellotto D, Dentali F, Pignone AM, D'Avino M, Buso R, Valerio A, Muiesan ML, Desideri G, Pengo M, Bilo G, Parati G, Fontanella A; FADOI HYP-OP Study Group. Orthostatic Hypotension in Hypertensive Patients Hospitalized in Italian Internal Medicine Departments: FADOI-HYP-OP Study. High Blood Press Cardiovasc Prev. 2026 Jul 15. doi: 10.1007/s40292-026-00808-2. Online ahead of print.
PubMed 42455464
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orthostatic Hypotension in Hypertensive Patient Hospitalized in Internal Medicine - Prevalence, Concomitant Conditions and Outcomes
- ClinicalTrials.gov ID
- NCT05247060
- Acronym / sponsor ID
- IP-OP / FADOI.02.2018
- Conditions
- Hospitalization
- Keywords
- orthostatic hypotension, Internal Medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Fadoi Foundation, ItalyUniversity, hospital or other
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 18 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypertensive Patients Hospitalized in Internal Medicine | – | Other: no experimental interventionClinical data will be collected from all consecutive patients diagnosed with arterial hypertension hospitalized in Internal Medicine and able to assume the erect station |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients diagnosed with arterial hypertension hospitalized in Internal Medicine and able to assume the erect station
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Presence of arterial hypertension (known or discovered at hospitalization)
- Signature of Informed Consent
Key exclusion criteria (1 listed)
- Patients unable to take the standing station for a few minutes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no experimental interventionThere will not be any experimental intervention. The study will be conducted according with normal clinical practice | Other | Hypertensive Patients Hospitalized in Internal Medicine |
Primary outcome
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
8 secondary outcomes
Prevalence of orthostatic hypotension
Time frame: 4 months
Gender differences in prevalence and conditions associated with orthostatic hypotension
Time frame: 4 months
Level of cognitive impairment of the subjects studied, and relationship with orthostatic hypotension
Time frame: 4 months
Relationship between orthostatic hypotension and a Fragility Index
Time frame: 4 months
Relationship between orthostatic hypotension and comorbidity by calculating the index of Charlson comorbidity
Time frame: 4 months
Prescription drugs on the presence and severity of hypotension Orthostatic
Time frame: 4 months
Presence of orthostatic hypertension
Time frame: 4 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Derived from this study: PubMed 42455464Ferri C, Mazza A, Manfellotto D, Dentali F, Pignone AM, D'Avino M, Buso R, Valerio A, Muiesan ML, Desideri G, Pengo M, Bilo G, Parati G, Fontanella A; FADOI HYP-OP Study Group. Orthostatic Hypotension in Hypertensive Patients Hospitalized in Italian Internal Medicine Departments: FADOI-HYP-OP Study. High Blood Press Cardiovasc Prev. 2026 Jul 15. doi: 10.1007/s40292-026-00808-2. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Fontanella, MD study director
FADOI FOUNDATION
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hospitalization, run by Fadoi Foundation, Italy at 33 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical conditions ( physiological parameters, copatologies) associated with the presence of orthostatic hypotension (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05247060, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.