Predictive Values of Blood Pressure and Arterial Stiffness in Institutionalized Very Aged Population (PARTAGE)

July 29, 2015 updated by: Central Hospital, Nancy, France

Morbidity and Mortality Based on Blood Pressure and Arterial Stiffness in Institutionalized Persons Aged 80 and Over: Study PARTAGE (Predictive Values of Blood Pressure and Arterial Stiffness in Institutionalized Very Aged Population).

Introduction: High blood pressure especially systolic hypertension is a common condition in the elderly and is considered as a major determinant not only of cardiovascular (CV) morbidity and mortality, but also of several other age-related diseases, frailty and loss of autonomy. Actually, the association between BP levels and morbidity and mortality in the very elderly persons with several co-morbidities remains a controversial issue

Objectives: The aim of the PARTAGE study (Predictive values of blood pressure and arterial stiffness in institutionalized very aged population)is to determine the predictive value of blood pressure (BP) and arterial stiffness for overall mortality, major cardiovascular events and cognitive decline in a large population of institutionalized subjects aged 80 and over.

Methods: The population is composed of 1130 subjects aged over 80, living in nursing home, included by four french university hospitals centre (Nancy, Dijon, Paris, Toulouse) and two Italian (Cesena, Verona). Subjects with severe dementia and a very low level of autonomy are excluded from the study During the first visit, blood pressure were measured using an automatic monitor by physician in sitting and standing position (clinical BP and Orthostatic BP) and by a self measurement of blood pressure 3 measurements, in the morning and the evening, during 3 consecutive days).

Arterial stiffness is evaluated by measuring the carotid-femoral and carotid-radial pulse wave velocity (PWV) with the PulsePen® automatic device. Deaths and cardiovascular events are recorded during a follow-up of 2 years.

The hypothesis of the PARTAGE longitudinal study is that in very elderly frail individuals with multiple co-morbidities, CV risk could be better evaluated by combining self-measurements of BP and direct evaluation of arterial stiffness which are less influenced by the above mentioned disease and co-morbidities.

Study Overview

Status

Completed

Conditions

Detailed Description

The aim of PARTAGE study (Predictive values of blood pressure and arterial stiffness in institutionalized very aged population) is to determine the predictive value of blood pressure (BP) and arterial stiffness estimated by pulse wave velocity (PWV) on overall mortality, major CV events and cognitive decline in a large population of subjects living in nursing homes aged 80 and over.

Method:

Participants are included if they are aged 80 year old and over, are institutionalized and if they have signed the informed consent.

Persons are excluded if they have severe dementia (Mini Mental Status Examination: MMSE<12), a low level of autonomy (Activity of daily living: ADL≤2) and they are under guardianship or "a measure of legal protection".

All geriatric assessment instruments and arterial measures are applied by several trained medical research teams (geriatricians, cardiologists, psychologists) present at each university hospitals centre. All medical teams received the same standard operating procedures. All the assessments are performed in the nursing homes.

Clinical data collection During the first visit in the nursing home, the medical research team collect a large amount of information during a face-to-face interview and from patient's medical records. Following information are recorded for each participant in a case report form (CRF): sociodemographic characteristics, educational level, medical history, chronic diseases (cardio vascular, central nervous system, respiratory), depressive symptoms, history of falls, co morbidity and medication use.

Additionally, a clinical examination of functional status, cognitive function, blood pressure and arterial stiffness are realized by medical research teams.

  • Comorbidities are quantified using the Charlson combined comorbidity index.
  • Functional status is evaluated by the Katz Index of independence in ability in activities of daily living (ADL) (bathing, dressing, going to the toilet, transferring from bed to chair, continence and feeding).
  • Cognitive status was assessed using the Mini-Mental-Status-Examination (MMSE), which is a global measurement of cognitive function evaluating various dimensions of cognition (memory, calculation, orientation in space and time, language, and word recognition).

Peripheral blood pressure measurements:

Peripheral BP and heart rate (HR) are performed at brachial artery level using the validated automated oscillometric device Colson DM-H20 (Dupont Médical, Frouard, France). Both clinical and self-measurement of blood pressure are performed in this study.

  • Clinical BP measurements are performed in the morning (from 8 am to noon), by doctors or nurses, in the patient's room or in the infirmary of the institute, after 10 minutes rest. All measurements are repeated three times, with intervals of 3 min on the left arm in a sitting position without replacing the cuff between the three measurements, according to the specific recommendations of the European Society of Hypertension.
  • Self-measurements of BP are performed following the rule of 3 (3 measurements morning and evening during 3 consecutive days) according to the protocol proposed by the French society of hypertension. Self-measurements are performed by the subject her/himself in the room where he/she lives habitually. In case of difficulty, measurement are realized with the assistance of the nurse of the medical research team or of the institution.

Central blood pressure measurement Central BP values and aortic pressure waveform are obtained from the common carotid waveform using applanation tonometry. The PulsePen device (DiaTecne srl, Milan, Italy), a validated, easy to use, high-fidelity tonometer is used.

Pulse wave velocity PulsePen device is also used to measuring carotid-radial pulse wave velocity (PWV) which reflects upper limb arterial stiffness and carotid-femoral PWV corresponding to the aortic stiffness.

Follow-up data:

Medical research teams record every 3 months during a follow-up of 2 years deaths and following cardiovascular events: stroke, transient ischemic attack, myocardial infarction, unstable angina, acute pulmonary oedema, aortic aneurysm rupture, peripheral arterial thromboembolism, venous thrombosis and other major cardiovascular event. Moreover, a new assessment of autonomy, by ADL, and cognitive functions, by MMSE, are achieved in the cohort by the research teams one year and two year after the first visit.

Study Type

Observational

Enrollment (Actual)

1130

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
      • Dijon, France, 21000
        • University hospital of Dijon (Centre de Champmaillot)
      • Paris, France
        • Hopital BROCA
      • Toulouse, France, 31000
        • Hôpital La Grave
      • Vandoeuvre-les-Nancy, France, 54500
        • University Hospital of Nancy
  • Italy
      • Cesena, Italy
        • Hospital of Cesena
      • Verona, Italy
        • Civil hospital Maggiore (Geriatrics)

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

80 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This population-based study included 1200 voluntary subjects aged 80 and older, living in nursing home, included by four french university hospitals centre (Nancy, Dijon, Paris, Toulouse) and two Italian (Cesena, Verona).

Description

Inclusion Criteria:

  • women and men aged 80 year old and over
  • living in nursing home
  • who signed the informed consent.

Exclusion Criteria:

  • severe dementia (Mini Mental Status Examination: MMSE<12)
  • a low level of autonomy (Activity of daily living: ADL≤2)
  • under guardianship or "a measure of legal protection".

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total Mortality
Time Frame: 2 years Follow-up
2 years Follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Cardiovascular morbidity Cognitive decline
Time Frame: 2 years follow-up
2 years follow-up

Collaborators and Investigators

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

Sponsor

Central Hospital, Nancy, France

Collaborators

Ministry of Health, France
Boehringer Ingelheim
French Cardiology Society

Investigators

  • Principal Investigator: Athanase BENETOS, Professor, University Hospital of Nancy, department of geriatrics.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2007

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

May 12, 2009

First Submitted That Met QC Criteria

May 12, 2009

First Posted (Estimate)

May 13, 2009

Study Record Updates

Last Update Posted (Estimate)

July 30, 2015

Last Update Submitted That Met QC Criteria

July 29, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006-A00042-49

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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