NCT05845736

Brief Summary

Neurocognitive disorders and hypertension occur commonly with aging. While, by definition, older adults are at high cardiovascular risk, there is no guideline exist currently on blood pressure management of elderly hypertension. However, studies have shown that in aging adults, high blood pressure helps prevent against cognitive decline, and low blood pressure on antihypertensive drugs could accelerate it. This study aims at investigating if pharmacological treatment of hypertension in the very elderly is influenced by presence and severity of neurocognitive disorders. Our research hypothesis is that the drug management of hypertension in patients 80 years of age or older more is all the less aggressive as the neurocognitive disorders are advanced.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
353

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 1, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

Same day

First QC Date

March 26, 2023

Last Update Submit

May 4, 2023

Conditions

Keywords

Neurocognitive DisordersDementiaHypertensionAged, 80 and over

Outcome Measures

Primary Outcomes (1)

  • number of antihypertensive agents

    among ACEI/ARB2, calcium channel blocker, thiazides and related, central antihypertensive beta blocker

    during inclusion

Secondary Outcomes (3)

  • class of antihypertensive medications

    during inclusion

  • systolic and diastolic blood pressure

    during inclusion

  • orthostatic hypotension

    during inclusion

Study Arms (4)

control group

absence of neurocognitive disorder (ND), Mini-Mental State Examination (MMSE) from 27 to 30 inclusive

Drug: Antihypertensive Agents

mild neurocognitive disorder

MMSE from 21 to 26 inclusive

Drug: Antihypertensive Agents

moderate neurocognitive disorder

MMSE from 11 to 20 inclusive

Drug: Antihypertensive Agents

severe neurocognitive disorder

MMSE less than or equal to 10

Drug: Antihypertensive Agents

Interventions

number of hypertensive drugs

control groupmild neurocognitive disordermoderate neurocognitive disordersevere neurocognitive disorder

Eligibility Criteria

Age80 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients aged 80 years or more and hypertensive who received a Comprehensive Geriatric Assessment (including a mini mental state examination) as part of a frailty, memory or oncogeriatric assessment, in day hospital in the geriatric department in University Hospital of Nancy in 2022.

You may qualify if:

  • to be 80 years of age
  • with history of hypertension and/or on hypertensive drug(s)

You may not qualify if:

  • legal protection measure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Régional Universitaire de Nancy

Nancy, 54000, France

Location

MeSH Terms

Conditions

Neurocognitive DisordersDementiaHypertension

Interventions

Antihypertensive Agents

Condition Hierarchy (Ancestors)

Mental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

March 26, 2023

First Posted

May 6, 2023

Study Start

January 1, 2022

Primary Completion

January 1, 2022

Study Completion

December 12, 2022

Last Updated

May 6, 2023

Record last verified: 2023-05

Locations