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

29 de julho de 2015 atualizado por: 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.

Visão geral do estudo

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Real)

1130

Contactos e Locais

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Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

80 anos e mais velhos (Adulto mais velho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

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).

Descrição

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".

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
Total Mortality
Prazo: 2 years Follow-up
2 years Follow-up

Medidas de resultados secundários

Medida de resultado
Prazo
Cardiovascular morbidity Cognitive decline
Prazo: 2 years follow-up
2 years follow-up

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Athanase BENETOS, Professor, University Hospital of Nancy, department of geriatrics.

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de janeiro de 2007

Conclusão Primária (Real)

1 de dezembro de 2013

Conclusão do estudo (Real)

1 de dezembro de 2013

Datas de inscrição no estudo

Enviado pela primeira vez

12 de maio de 2009

Enviado pela primeira vez que atendeu aos critérios de CQ

12 de maio de 2009

Primeira postagem (Estimativa)

13 de maio de 2009

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

30 de julho de 2015

Última atualização enviada que atendeu aos critérios de controle de qualidade

29 de julho de 2015

Última verificação

1 de julho de 2015

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 2006-A00042-49

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