Orthostatic And Postprandial Hypotension In Hospitalized Older Adults (HOPE65) (HOPE65)

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.

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

Study Overview

• Status: Not yet recruiting
• Conditions: Orthostatic Hypotension; Postprandial Hypotension

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 Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Amela Kabaklić, MD, PhD; Phone Number: +386 1 522 43 05; Email: amela.kabaklic@kclj.si

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • University Medical Centre Ljubljana
    • Contact: Amela Kabaklić, MD, PhD; Phone Number: +386 1 522 43 05; Email: amela.kabaklic@kclj.si

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Hospitalized adults aged 65 years and older admitted to internal medicine departments at the University Medical Centre Ljubljana.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (during index hospitalization)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Falls	Occurrence of falls during the 12-month follow-up period.	12 months
Number of Participants with Syncope	Occurrence of syncope during the 12-month follow-up period.	12 months
Number of Participants with Functional Decline	Functional decline during follow-up, assessed based on information from medical records and clinical history.	12 months
Number of Participants with Hospital Readmission	Hospital readmission during the 12-month follow-up period.	12 months
Number of Participants Who Died from Any Cause	Death from any cause during the 12-month follow-up period.	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.	12 months

Collaborators and Investigators

• Sponsor: University Medical Centre Ljubljana
• Investigators: Principal Investigator: Amela Kabaklić, MD, PhD, University Medical Centre Ljubljana

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): June 1, 2030

Study Registration Dates

• First Submitted: March 12, 2026
• First Submitted That Met QC Criteria: March 17, 2026
• First Posted (Actual): March 20, 2026

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Older Adults; Falls; Antihypertensive Medication; Geriatric Syndromes; Comprehensive Geriatric Assessment; Hospitalized Patients; Blood Pressure Regulation
• Additional Relevant MeSH Terms: Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases; Orthostatic Intolerance; Hypotension; Hypotension, Orthostatic
• Other Study ID Numbers: HOPE65_UKCLJ_2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to data protection and privacy regulations.

Drug and device information, study documents

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