STEP DOWN strategy
Otherreduction of the number of antihypertensive medication according to:
- the systolic blood pressure levels,
- co-morbidities
NCT Number: NCT03453268
The investigators hypothesize that a gradual reduction in antihypertensive treatment in medical-social institutions patients with low systolic blood pressure (SBP) can improve survival through a controlled increase in SBP and a decrease in secondary morbidity due to 'overmedication'.
Accordingly, the investigators propose a randomized, case/control trial in NH patients ≥ 80 years with a SBP<130 mmHg with >1 anti-Htn drugs. This trial will consist of two parallel arms: the intervention arm will entail antihypertensive drug step-down, while the control arm will comprise the standard anti-hypertensive treatment.
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Notify Me80 year and older
All sexes
Interventional
Not applicable
CHU Angoulême (Expert center), Angoulême, France
High blood pressure (BP), principally systolic hypertension, is a common condition in older people and is considered a major determinant not only of cardiovascular morbidity and mortality, but also of several other age-related diseases, including frailty, cognitive decline and loss of autonomy. The Hypertension in the Very Elderly Treatment (HYVET) study showed the beneficial effect of antihypertensive treatment in patients ≥ 80 years. More recently, the Systolic Blood Pressure Intervention Trial (SPRINT) study showed that even in subjects 75 years and older, CVD outcomes and total mortality were reduced with intensive treatment as compared to the standard therapeutic strategies. However, both HYVET and SPRINT were conducted in selected populations since they excluded the most frail subjects, those with clinically significant cognitive decline and dementia, those with several cardiovascular and other co-morbidities, as well as patients living in medical-social institutions.
The only way is to conduct a controlled clinical trial.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
reduction of the number of antihypertensive medication according to:
usual treatment
Time frame: up to 48 months
All-cause mortality in each of the two groups during follow-up (maximum 48 months depending on when the patient was included).
Time frame: up to 48 months
Occurrence of major CV events (myocardial infarction, hospitalisation for heart failure, stroke, other serious CV complication requiring specific management or hospitalisation)
Time frame: up to 48 months
SBP, diastolic blood pressure (DBP), pulse pressure (PP) and heart rate (HR) in the sitting position (or supine if sitting is not possible) and standing position (if possible), during the 24 to 48 month follow-up period.s
Time frame: up to 48 months
Frailty tests: weight, muscle strength (handgrip), Short Physical Performance Battery (SPPB) and assessment of independence using the ADL (Activities of Daily Living) scale every 6 months during the follow-up period at medical visits.
Time frame: up to 48 months
Assessment of cognitive functions by MMSE (Mini Mental State Evaluation) every six months during the follow-up period at medical visits.
Time frame: up to 48 months
Number of falls and fractures
Time frame: up to 48 months
Total number of medications: number of antihypertensive medications during the 24 to 48 month follow-up period.
Time frame: up to 48 months
Quality of life scales (EQ 5D) once a year during the follow-up period at medical visits.
Time frame: up to 48 months
Occurrence of cardiac decompensation, whether fatal or not, and monitoring of changes in blood pressure.
Time frame: up to 48 months
Number of patients at high risk of cardiac decompensation.
Assistance Publique - Hôpitaux de Paris
Other
Impact of Reducing Antihypertensive Treatment on Mortality in Frail Subjects With Low Systolic Blood Pressure (SBP). Multicenter, Randomized Controlled Study of Subjects Aged 80 and Over, Living in Nursing Homes and Other IMS.
Acronym: RETREAT-FRAIL
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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