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

NCT00901355 | Completed DMC

• 1 other identifier: 2006-A00042-49
• Study Type: observational
• Target: 1,130
• Locations: 2 countries
• Sites: 6

Brief Summary

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.

Conditions

Hypertension; Elderly; Cardiovascular Mortality; Cognitive Impairment; Morbidity

Keywords

Blood pressure; Arterial stiffness; Morbidity; Mortality; Elderly

Outcome Measures

Primary Outcomes (1)

• Total Mortality

  2 years Follow-up

Secondary Outcomes (1)

• Cardiovascular morbidity Cognitive decline

  2 years follow-up

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• 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".

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead
• French Cardiology Society: collaborator
• Boehringer Ingelheim: collaborator
• Ministry of Health, France: collaborator

Study Sites (6)

University hospital of Dijon (Centre de Champmaillot)

Dijon, 21000, France

Location

Hôpital Broca

Paris, France

Location

Hôpital La Grave

Toulouse, 31000, France

Location

University hospital of Nancy

Vandœuvre-lès-Nancy, 54500, France

Location

Hospital of Cesena

Cesena, Italy

Location

Civil hospital Maggiore (Geriatrics)

Verona, Italy

Location

Related Publications (18)

• Meaume S, Benetos A, Henry OF, Rudnichi A, Safar ME. Aortic pulse wave velocity predicts cardiovascular mortality in subjects >70 years of age. Arterioscler Thromb Vasc Biol. 2001 Dec;21(12):2046-50. doi: 10.1161/hq1201.100226.

  PMID: 11742883 BACKGROUND

• Boshuizen HC, Izaks GJ, van Buuren S, Ligthart GJ. Blood pressure and mortality in elderly people aged 85 and older: community based study. BMJ. 1998 Jun 13;316(7147):1780-4. doi: 10.1136/bmj.316.7147.1780.

  PMID: 9624064 BACKGROUND

• Satish S, Zhang DD, Goodwin JS. Clinical significance of falling blood pressure among older adults. J Clin Epidemiol. 2001 Sep;54(9):961-7. doi: 10.1016/s0895-4356(01)00360-2.

  PMID: 11520657 BACKGROUND

• Askari M, Kiely DK, Lipsitz LA. Is pulse pressure a predictor of cardiovascular complications in a frail elderly nursing home population? Aging Clin Exp Res. 2004 Jun;16(3):206-11. doi: 10.1007/BF03327385.

  PMID: 15462463 BACKGROUND

• Alecu C, Labat C, Kearney-Schwartz A, Fay R, Salvi P, Joly L, Lacolley P, Vespignani H, Benetos A. Reference values of aortic pulse wave velocity in the elderly. J Hypertens. 2008 Nov;26(11):2207-12. doi: 10.1097/HJH.0b013e32830e4932.

  PMID: 18854762 BACKGROUND

• Benetos A, Adamopoulos C, Bureau JM, Temmar M, Labat C, Bean K, Thomas F, Pannier B, Asmar R, Zureik M, Safar M, Guize L. Determinants of accelerated progression of arterial stiffness in normotensive subjects and in treated hypertensive subjects over a 6-year period. Circulation. 2002 Mar 12;105(10):1202-7. doi: 10.1161/hc1002.105135.

  PMID: 11889014 BACKGROUND

• Beckett NS, Peters R, Fletcher AE, Staessen JA, Liu L, Dumitrascu D, Stoyanovsky V, Antikainen RL, Nikitin Y, Anderson C, Belhani A, Forette F, Rajkumar C, Thijs L, Banya W, Bulpitt CJ; HYVET Study Group. Treatment of hypertension in patients 80 years of age or older. N Engl J Med. 2008 May 1;358(18):1887-98. doi: 10.1056/NEJMoa0801369. Epub 2008 Mar 31.

  PMID: 18378519 BACKGROUND

• Salvi P, Lio G, Labat C, Ricci E, Pannier B, Benetos A. Validation of a new non-invasive portable tonometer for determining arterial pressure wave and pulse wave velocity: the PulsePen device. J Hypertens. 2004 Dec;22(12):2285-93. doi: 10.1097/00004872-200412000-00010.

  PMID: 15614022 BACKGROUND

• Salvi P, Grillo A, Gautier S, Labat C, Salvi L, Valbusa F, Baldi C, Rovina M, Simon G, Gao L, Tan I, Fabris B, Carretta R, Avolio AP, Parati G, Benetos A. Myocardial oxygen supply and demand imbalance predicts mortality in older nursing home residents: The PARTAGE study. J Am Geriatr Soc. 2024 Apr;72(4):1048-1059. doi: 10.1111/jgs.18752. Epub 2024 Jan 13.

  PMID: 38217343 DERIVED

• Mourad JJ, Agnoletti D, Labat C, Gautier S, Salvi P, Valbusa F, Hanon O, Toulza O, Manckoundia P, Fantin F, Rolland Y, Benetos A. Interest of Combined Blood Pressure Measurements in Very Old Frail Subjects: The PARTAGE Study. Am J Hypertens. 2018 Jul 16;31(8):950-956. doi: 10.1093/ajh/hpy077.

  PMID: 30016415 DERIVED

• Agnoletti D, Valbusa F, Labat C, Gautier S, Mourad JJ, Benetos A; PARTAGE study Investigators. Evidence for a Prognostic Role of Orthostatic Hypertension on Survival in a Very Old Institutionalized Population. Hypertension. 2016 Jan;67(1):191-6. doi: 10.1161/HYPERTENSIONAHA.115.06386. Epub 2015 Nov 23.

  PMID: 26597824 DERIVED

• Watfa G, Benetos A, Kearney-Schwartz A, Labat C, Gautier S, Hanon O, Salvi P, Joly L; PARTAGE study investigators. Do Arterial Hemodynamic Parameters Predict Cognitive Decline Over a Period of 2 Years in Individuals Older Than 80 Years Living in Nursing Homes? The PARTAGE Study. J Am Med Dir Assoc. 2015 Jul 1;16(7):598-602. doi: 10.1016/j.jamda.2015.01.098. Epub 2015 Mar 14.

  PMID: 25783622 DERIVED

• Miljkovic D, Perret-Guillaume C, Alla F, Salvi P, Erpelding ML, Benetos A. Correlation between peripheral blood pressure and pulse-wave velocity values in the institutionalized elderly persons 80 years of age and older: the PARTAGE study. Am J Hypertens. 2013 Feb;26(2):163-73. doi: 10.1093/ajh/hps042. Epub 2012 Dec 27.

  PMID: 23382400 DERIVED

• Benetos A, Gautier S, Labat C, Salvi P, Valbusa F, Marino F, Toulza O, Agnoletti D, Zamboni M, Dubail D, Manckoundia P, Rolland Y, Hanon O, Perret-Guillaume C, Lacolley P, Safar ME, Guillemin F. Mortality and cardiovascular events are best predicted by low central/peripheral pulse pressure amplification but not by high blood pressure levels in elderly nursing home subjects: the PARTAGE (Predictive Values of Blood Pressure and Arterial Stiffness in Institutionalized Very Aged Population) study. J Am Coll Cardiol. 2012 Oct 16;60(16):1503-11. doi: 10.1016/j.jacc.2012.04.055. Epub 2012 Sep 19.

  PMID: 22999729 DERIVED

• Valbusa F, Labat C, Salvi P, Vivian ME, Hanon O, Benetos A; PARTAGE investigators. Orthostatic hypotension in very old individuals living in nursing homes: the PARTAGE study. J Hypertens. 2012 Jan;30(1):53-60. doi: 10.1097/HJH.0b013e32834d3d73.

  PMID: 22080223 DERIVED

• Benetos A, Watfa G, Hanon O, Salvi P, Fantin F, Toulza O, Manckoundia P, Agnoletti D, Labat C, Gautier S; PARTAGE Study Investigators. Pulse wave velocity is associated with 1-year cognitive decline in the elderly older than 80 years: the PARTAGE study. J Am Med Dir Assoc. 2012 Mar;13(3):239-43. doi: 10.1016/j.jamda.2010.08.014. Epub 2010 Oct 20.

  PMID: 21450208 DERIVED

• Salvi P, Safar ME, Labat C, Borghi C, Lacolley P, Benetos A; PARTAGE Study Investigators. Heart disease and changes in pulse wave velocity and pulse pressure amplification in the elderly over 80 years: the PARTAGE Study. J Hypertens. 2010 Oct;28(10):2127-33. doi: 10.1097/HJH.0b013e32833c48de.

  PMID: 20634719 DERIVED

• Benetos A, Buatois S, Salvi P, Marino F, Toulza O, Dubail D, Manckoundia P, Valbusa F, Rolland Y, Hanon O, Gautier S, Miljkovic D, Guillemin F, Zamboni M, Labat C, Perret-Guillaume C. Blood pressure and pulse wave velocity values in the institutionalized elderly aged 80 and over: baseline of the PARTAGE study. J Hypertens. 2010 Jan;28(1):41-50. doi: 10.1097/HJH.0b013e328332b879.

  PMID: 19809365 DERIVED

MeSH Terms

Conditions

Hypertension; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Athanase BENETOS, Professor

  University Hospital of Nancy, department of geriatrics.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2009
• First Posted: May 13, 2009
• Study Start: January 1, 2007
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 30, 2015

Record last verified: 2015-07

Locations

FR (4); IT (2)