NCT07485998

Brief 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. 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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
47mo left

Started Apr 2026

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress8%
Apr 2026Jun 2030

First Submitted

Initial submission to the registry

March 12, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 20, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2030

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2030

Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

4 years

First QC Date

March 12, 2026

Last Update Submit

March 17, 2026

Conditions

Keywords

Older AdultsHospitalized PatientsBlood Pressure RegulationFallsGeriatric SyndromesComprehensive Geriatric AssessmentAntihypertensive Medication

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Number of Participants with Falls

    12 months

  • Number of Participants with Syncope

    12 months

  • Number of Participants with Functional Decline

    12 months

  • Number of Participants with Hospital Readmission

    12 months

  • Number of Participants Who Died from Any Cause

    12 months

  • +1 more secondary outcomes

Study Arms (1)

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.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Hypotension, Orthostatic

Condition Hierarchy (Ancestors)

Orthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesHypotensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Amela Kabaklić, MD, PhD

    University Medical Centre Ljubljana

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amela Kabaklić, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Specialist in Internal Medicine

Study Record Dates

First Submitted

March 12, 2026

First Posted

March 20, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

April 1, 2030

Study Completion (Estimated)

June 1, 2030

Last Updated

March 20, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to data protection and privacy regulations.

Locations