The Impact of Dementia and Neurocognitive Disorders on Hypertension Treatment in the Elderly (TAHOC)

May 4, 2023 updated by: Pr Athanase BENETOS, Central Hospital, Nancy, France

The Impact of Dementia and Neurocognitive Disorders on Hypertension Treatment in the Very Elderly: the TAHOC Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

353

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nancy, France, 54000
        • Centre Hospitalier Régional Universitaire de Nancy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • legal protection measure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
control group
absence of neurocognitive disorder (ND), Mini-Mental State Examination (MMSE) from 27 to 30 inclusive
Drug: Antihypertensive Agents
number of hypertensive drugs
mild neurocognitive disorder
MMSE from 21 to 26 inclusive
Drug: Antihypertensive Agents
number of hypertensive drugs
moderate neurocognitive disorder
MMSE from 11 to 20 inclusive
Drug: Antihypertensive Agents
number of hypertensive drugs
severe neurocognitive disorder
MMSE less than or equal to 10
Drug: Antihypertensive Agents
number of hypertensive drugs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of antihypertensive agents
Time Frame: during inclusion
among ACEI/ARB2, calcium channel blocker, thiazides and related, central antihypertensive beta blocker
during inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
class of antihypertensive medications
Time Frame: during inclusion
among ACEI/ARB2, calcium channel blocker, thiazides and related, central antihypertensive beta blocker
during inclusion
systolic and diastolic blood pressure
Time Frame: during inclusion
blood pressure measured with upper arm cuffs
during inclusion
orthostatic hypotension
Time Frame: during inclusion
a systolic blood pressure decrease of at least 20 mm Hg or a diastolic blood pressure decrease of at least 10 mm Hg within three minutes of standing
during inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

January 1, 2022

Study Completion (Actual)

December 12, 2022

Study Registration Dates

First Submitted

March 26, 2023

First Submitted That Met QC Criteria

April 25, 2023

First Posted (Estimate)

May 5, 2023

Study Record Updates

Last Update Posted (Estimate)

May 8, 2023

Last Update Submitted That Met QC Criteria

May 4, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023PI017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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