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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Central Hospital, Nancy, France.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
French Cardiology Society
Boehringer Ingelheim
Ministry of Health, France
Information provided by:
Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT00901355
First received: May 12, 2009
Last updated: NA
Last verified: September 2006
History: No changes posted
  Purpose

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.


Condition
Hypertension
Elderly
Cardiovascular Mortality
Cognitive Impairment
Morbidity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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).

Resource links provided by NLM:


Further study details as provided by Central Hospital, Nancy, France:

Primary Outcome Measures:
  • Total Mortality [ Time Frame: 2 years Follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardiovascular morbidity Cognitive decline [ Time Frame: 2 years follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 1200
Study Start Date: January 2007
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   80 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).

Criteria

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".
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00901355

Locations
France
University hospital of Dijon (Centre de Champmaillot)
Dijon, France, 21000
Hôpital Broca
Paris, France
Hôpital La Grave
Toulouse, France, 31000
University hospital of Nancy
Vandoeuvre-les-Nancy, France, 54500
Italy
Hospital of Cesena
Cesena, Italy
Civil hospital Maggiore (Geriatrics)
Verona, Italy
Sponsors and Collaborators
Central Hospital, Nancy, France
French Cardiology Society
Boehringer Ingelheim
Ministry of Health, France
Investigators
Principal Investigator: Athanase BENETOS, Professor University Hospital of Nancy, department of geriatrics.
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Athanase Benetos, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT00901355     History of Changes
Other Study ID Numbers: 2006-A00042-49
Study First Received: May 12, 2009
Last Updated: May 12, 2009
Health Authority: France: Ministry of Health

Keywords provided by Central Hospital, Nancy, France:
Blood pressure
Arterial stiffness
Morbidity
Mortality
Elderly

Additional relevant MeSH terms:
Hypertension
Cognition Disorders
Vascular Diseases
Cardiovascular Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 26, 2014