HypertensionPARTAGENCT00901355
Predictive Values of Blood Pressure and Arterial Stiffness in Institutionalized Very Aged Population
An observational study of Hypertension and Elderly, run by Central Hospital, Nancy, France at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 80 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Elderly, Cardiovascular Mortality
- How many people
- 1,130 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Jan 2007to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 80 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
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).
Who may be able to join
- women and men aged 80 year old and over
- living in nursing home
- who signed the informed consent.
Who cannot join
- 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".
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
France4 sites
University hospital of Dijon (Centre de Champmaillot)
Dijon, 21000
Hôpital Broca
Paris
Hôpital La Grave
Toulouse, 31000
University hospital of Nancy
Vandœuvre-lès-Nancy, 54500
Italy2 sites
Hospital of Cesena
Cesena
Civil hospital Maggiore (Geriatrics)
Verona
About this study
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).
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.
Read more
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.
Read the 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.
- Conditions
- Hypertension, Elderly, Cardiovascular Mortality, Cognitive Impairment, Morbidity
- Keywords
- Blood pressure, Arterial stiffness, Morbidity, Mortality, Elderly
- Medical subject headings
- Hypertension, Cognitive Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Mortality
Measured: 2 years Follow-up
Secondary outcomes (1)
Cardiovascular morbidity Cognitive decline
Measured: 2 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2009 (estimated)
- Study startJan 2007
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- French Cardiology Society, Boehringer Ingelheim, Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Athanase BENETOS, Professor, Principal investigator, University Hospital of Nancy, department of geriatrics.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00901355
- Sponsor's protocol ID
- 2006-A00042-49
- Acronym
- PARTAGE
- Status last verified
- Jul 2015
- First submitted
- 12 May 2009
- Last updated
- 30 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 11742883Boshuizen 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.
PubMed 9624064Satish 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.
PubMed 11520657Askari 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.
PubMed 15462463Alecu 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.
PubMed 18854762Benetos 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.
PubMed 11889014Beckett 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.
PubMed 18378519Salvi 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.
PubMed 15614022Salvi 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.
PubMed 38217343Mourad 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.
PubMed 30016415Agnoletti 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.
PubMed 26597824Watfa 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.
PubMed 25783622Miljkovic 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.
PubMed 23382400Benetos 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.
PubMed 22999729Valbusa 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.
PubMed 22080223
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT00901355
- Acronym / sponsor ID
- PARTAGE / 2006-A00042-49
- Conditions
- Hypertension, Elderly, Cardiovascular Mortality, Cognitive Impairment, Morbidity
- Keywords
- Blood pressure, Arterial stiffness, Morbidity, Mortality, Elderly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,130 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- French Cardiology Society, Boehringer Ingelheim, Ministry of Health, France
- Study start
- Jan 2007
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 13 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- 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).
Key inclusion criteria (3 listed)
- women and men aged 80 year old and over
- living in nursing home
- who signed the informed consent.
Key exclusion criteria (3 listed)
- 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".
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total Mortality
Time frame: 2 years Follow-up
1 secondary outcome
Cardiovascular morbidity Cognitive decline
Time frame: 2 years follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2015.
- Background: PubMed 11742883Meaume 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.
- Background: PubMed 9624064Boshuizen 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.
- Background: PubMed 11520657Satish 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.
- Background: PubMed 15462463Askari 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.
- Background: PubMed 18854762Alecu 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.
- Background: PubMed 11889014Benetos 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.
- Background: PubMed 18378519Beckett 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.
- Background: PubMed 15614022Salvi 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.
- Derived from this study: PubMed 38217343Salvi 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.
- Derived from this study: PubMed 30016415Mourad 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.
- Derived from this study: PubMed 26597824Agnoletti 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.
- Derived from this study: PubMed 25783622Watfa 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Athanase BENETOS, Professor principal investigator
University Hospital of Nancy, department of geriatrics.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Elderly, run by Central Hospital, Nancy, France at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Mortality (time frame: 2 years Follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00901355, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2015.