Orthostatic HypotensionHOPE65NCT07485998
Orthostatic And Postprandial Hypotension In Hospitalized Older Adults (HOPE65)
An observational study of Orthostatic Hypotension and Postprandial Hypotension, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
The goal of this observational study is to determine how often orthostatic hypotension and postprandial hypotension occur in adults aged 65 years and older who are hospitalized in internal medicine departments. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Orthostatic Hypotension, Postprandial Hypotension
- How many people
- 500 participants
- Where
- 1 siteSlovenia
- Study dates
- Apr 2026to Jun 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Hospitalized adults aged 65 years and older admitted to internal medicine departments at the University Medical Centre Ljubljana.
Who may be able to join
- Age 65 years or older
- Hospitalization in internal medicine departments at the University Medical Centre Ljubljana
- Duration of hospitalization ≥48 hours
- Hemodynamic stability confirmed by the treating physician
- Ability to participate in study procedures
- Ability to stand (with or without assistive devices for walking)
- Written informed consent obtained
Who cannot join
- Medical condition preventing study procedures (e.g., need for continuous supine position)
- Inability to provide informed consent
- Refusal to participate
- Severe cognitive impairment or delirium
- Acute critical illness requiring intensive treatment
- Participation in another clinical study that could affect safety or study outcomes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia1 site
University Medical Centre Ljubljana
Ljubljana, 1000
Amela Kabaklić, MD, PhD, +386 1 522 43 05, amela.kabaklic@kclj.si
About this study
Official title: Orthostatic And Postprandial Hypotension In Hospitalized Older Adults: Prevalence And Association With Medications, Comorbidities, And Adverse Clinical Outcomes
The goal of this observational study is to determine how often orthostatic hypotension and postprandial hypotension occur in adults aged 65 years and older who are hospitalized in internal medicine departments.
Orthostatic hypotension is defined as an excessive drop in blood pressure after standing up from a lying or sitting position. Postprandial hypotension is an excessive drop in blood pressure that occurs after eating a meal. These conditions can increase the risk of falls, fainting, loss of independence, and other health problems in older adults.
Read more
The main questions this study aims to answer are:
- How common orthostatic hypotension and postprandial hypotension are in hospitalized adults aged 65 years and older.
- Whether these conditions are associated with medication use, chronic diseases, and geriatric syndromes (such as frailty, cognitive impairment, and functional decline).
Participants will:
- have blood pressure measured while lying down and standing
- have blood pressure measured after a meal
- undergo a comprehensive geriatric assessment, including evaluation of functional status, cognitive function, frailty, mobility, and nutritional status
- provide information about medications and medical history
- be followed for up to 12 months to record outcomes such as falls, syncope, hospitalization, and death
Read the detailed description
Orthostatic hypotension (OH) and postprandial hypotension (PPH) are common manifestations of impaired blood pressure regulation in older adults. Orthostatic hypotension is defined as a decrease in systolic blood pressure of at least 20 mmHg or diastolic blood pressure of at least 10 mmHg within 3 minutes of standing. Postprandial hypotension refers to a clinically significant decline in blood pressure occurring after a meal. Both conditions are associated with adverse outcomes in older adults, including falls, syncope, functional decline, loss of independence, and increased mortality. Despite their clinical importance, OH and PPH are frequently underrecognized in hospitalized patients.
This prospective observational cohort study aims to determine the prevalence of orthostatic hypotension and postprandial hypotension in adults aged 65 years and older hospitalized in internal medicine departments at the University Medical Centre Ljubljana. The study will also examine associations between OH and PPH and factors such as medication use, comorbidities, and geriatric syndromes.
Participants will undergo standardized orthostatic blood pressure measurements and assessment of postprandial blood pressure changes. In addition, a comprehensive geriatric assessment will be performed, including evaluation of functional status (activities of daily living), cognitive function, frailty, mobility, and nutritional status, using standardized instruments (e.g., Barthel Index, Timed Up and Go test, Mini Nutritional Assessment - Short Form, and Clinical Frailty Scale), as well as validated cognitive tests. Information on medications, comorbidities, and clinical characteristics will be collected through clinical assessment and review of medical records.
Participants will be followed for up to 12 months to assess clinically relevant outcomes, including falls, syncope, functional decline, rehospitalization, and mortality.
The findings of this study are expected to improve understanding of the epidemiology and clinical impact of orthostatic and postprandial hypotension in hospitalized older adults and may contribute to improved recognition and management of these conditions in clinical practice.
- Conditions
- Orthostatic Hypotension, Postprandial Hypotension
- Keywords
- Older Adults, Hospitalized Patients, Blood Pressure Regulation, Falls, Geriatric Syndromes, Comprehensive Geriatric Assessment, Antihypertensive Medication
- Medical subject headings
- Hypotension, Orthostatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adults aged 65 years and older hospitalized in internal medicine departments at the University Medic | Adults aged 65 years and older hospitalized in internal medicine departments at the University Medical Centre Ljubljana. Participants will undergo orthostatic and postprandial blood pressure measurements and comprehensive geriatric assessment, including evaluation of functional status, cognitive status, frailty, and other geriatric syndromes. Participants will be followed for up to 12 months to assess clinical outcomes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Orthostatic Hypotension and Postprandial Hypotension in Hospitalized Older Adults at Baseline
Prevalence of orthostatic hypotension and postprandial hypotension in hospitalized adults aged 65 years and older, assessed using standardized orthostatic blood pressure measurements and postprandial blood pressure measurements. Orthostatic hypotension is defined as a decrease in systolic blood pressure of ≥20 mmHg or diastolic blood pressure of ≥10 mmHg within 3 minutes of standing.
Measured: Baseline (during index hospitalization)
Secondary outcomes (6)
Number of Participants with Falls
Occurrence of falls during the 12-month follow-up period.
Measured: 12 months
Number of Participants with Syncope
Occurrence of syncope during the 12-month follow-up period.
Measured: 12 months
Number of Participants with Functional Decline
Functional decline during follow-up, assessed based on information from medical records and clinical history.
Measured: 12 months
Number of Participants with Hospital Readmission
Hospital readmission during the 12-month follow-up period.
Measured: 12 months
Number of Participants Who Died from Any Cause
Death from any cause during the 12-month follow-up period.
Measured: 12 months
Number of Participants with Major Adverse Cardiovascular Events
Occurrence of major adverse cardiovascular events, including myocardial infarction, stroke, or cardiovascular death, during the 12-month follow-up period.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2030 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthostatic HypotensionStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amela Kabaklić, University Medical Centre Ljubljana
- Investigators
- Amela Kabaklić, MD, PhD, Principal investigator, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07485998
- Sponsor's protocol ID
- HOPE65_UKCLJ_2026
- Acronym
- HOPE65
- Status last verified
- Mar 2026
- First submitted
- 12 Mar 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to data protection and privacy regulations.
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orthostatic And Postprandial Hypotension In Hospitalized Older Adults: Prevalence And Association With Medications, Comorbidities, And Adverse Clinical Outcomes
- ClinicalTrials.gov ID
- NCT07485998
- Acronym / sponsor ID
- HOPE65 / HOPE65_UKCLJ_2026
- Conditions
- Orthostatic Hypotension, Postprandial Hypotension
- Keywords
- Older Adults, Hospitalized Patients, Blood Pressure Regulation, Falls, Geriatric Syndromes, Comprehensive Geriatric Assessment, Antihypertensive Medication
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2030 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 20 Mar 2026 (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 goal of this observational study is to determine how often orthostatic hypotension and postprandial hypotension occur in adults aged 65 years and older who are hospitalized in internal medicine departments.
Orthostatic hypotension is defined as an excessive drop in blood pressure after standing up from a lying or sitting position. Postprandial hypotension is an excessive drop in blood pressure that occurs after eating a meal. These conditions can increase the risk of falls, fainting, loss of independence, and other health problems in older adults.
The main questions this study aims to answer are:
- How common orthostatic hypotension and postprandial hypotension are in hospitalized adults aged 65 years and older.
- Whether these conditions are associated with medication use, chronic diseases, and geriatric syndromes (such as frailty, cognitive impairment, and functional decline).
Participants will:
- have blood pressure measured while lying down and standing
- have blood pressure measured after a meal
- undergo a comprehensive geriatric assessment, including evaluation of functional status, cognitive function, frailty, mobility, and nutritional status
- provide information about medications and medical history
- be followed for up to 12 months to record outcomes such as falls, syncope, hospitalization, and death
Detailed description
Orthostatic hypotension (OH) and postprandial hypotension (PPH) are common manifestations of impaired blood pressure regulation in older adults. Orthostatic hypotension is defined as a decrease in systolic blood pressure of at least 20 mmHg or diastolic blood pressure of at least 10 mmHg within 3 minutes of standing. Postprandial hypotension refers to a clinically significant decline in blood pressure occurring after a meal. Both conditions are associated with adverse outcomes in older adults, including falls, syncope, functional decline, loss of independence, and increased mortality. Despite their clinical importance, OH and PPH are frequently underrecognized in hospitalized patients.
This prospective observational cohort study aims to determine the prevalence of orthostatic hypotension and postprandial hypotension in adults aged 65 years and older hospitalized in internal medicine departments at the University Medical Centre Ljubljana. The study will also examine associations between OH and PPH and factors such as medication use, comorbidities, and geriatric syndromes.
Participants will undergo standardized orthostatic blood pressure measurements and assessment of postprandial blood pressure changes. In addition, a comprehensive geriatric assessment will be performed, including evaluation of functional status (activities of daily living), cognitive function, frailty, mobility, and nutritional status, using standardized instruments (e.g., Barthel Index, Timed Up and Go test, Mini Nutritional Assessment - Short Form, and Clinical Frailty Scale), as well as validated cognitive tests. Information on medications, comorbidities, and clinical characteristics will be collected through clinical assessment and review of medical records.
Participants will be followed for up to 12 months to assess clinically relevant outcomes, including falls, syncope, functional decline, rehospitalization, and mortality.
The findings of this study are expected to improve understanding of the epidemiology and clinical impact of orthostatic and postprandial hypotension in hospitalized older adults and may contribute to improved recognition and management of these conditions in clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults aged 65 years and older hospitalized in internal medicine departments at the University Medic | – | –Adults aged 65 years and older hospitalized in internal medicine departments at the University Medical Centre Ljubljana. Participants will undergo orthostatic and postprandial blood pressure measurements and comprehensive geriatric assessment, including evaluation of functional status, cognitive status, frailty, and other geriatric syndromes. Participants will be followed for up to 12 months to assess clinical outcomes. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Hospitalized adults aged 65 years and older admitted to internal medicine departments at the University Medical Centre Ljubljana.
Key inclusion criteria (7 listed)
- Age 65 years or older
- Hospitalization in internal medicine departments at the University Medical Centre Ljubljana
- Duration of hospitalization ≥48 hours
- Hemodynamic stability confirmed by the treating physician
- Ability to participate in study procedures
Key exclusion criteria (6 listed)
- Medical condition preventing study procedures (e.g., need for continuous supine position)
- Inability to provide informed consent
- Refusal to participate
- Severe cognitive impairment or delirium
- Acute critical illness requiring intensive treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of Orthostatic Hypotension and Postprandial Hypotension in Hospitalized Older Adults at Baseline
Time frame: Baseline (during index hospitalization)
Prevalence of orthostatic hypotension and postprandial hypotension in hospitalized adults aged 65 years and older, assessed using standardized orthostatic blood pressure measurements and postprandial blood pressure measurements. Orthostatic hypotension is defined as a decrease in systolic blood pressure of ≥20 mmHg or diastolic blood pressure of ≥10 mmHg within 3 minutes of standing.
6 secondary outcomes
Number of Participants with Falls
Time frame: 12 months
Number of Participants with Syncope
Time frame: 12 months
Number of Participants with Functional Decline
Time frame: 12 months
Number of Participants with Hospital Readmission
Time frame: 12 months
Number of Participants Who Died from Any Cause
Time frame: 12 months
Number of Participants with Major Adverse Cardiovascular Events
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to data protection and privacy regulations.
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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.
Amela Kabaklić, MD, PhD principal investigator
University Medical Centre Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthostatic Hypotension and Postprandial Hypotension, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 7 inclusion and 6 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: opening soon, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amela Kabaklić, MD, PhD (+386 1 522 43 05, amela.kabaklic@kclj.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Orthostatic Hypotension and Postprandial Hypotension in Hospitalized Older Adults at Baseline (time frame: Baseline (during index hospitalization)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2026.