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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 1,048
- Locations
- 216
- Primary Endpoint
- All-cause mortality
Study Overview
Brief Summary
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.
Detailed Description
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.
- Interestingly, observational studies in these frail people, have shown no or even an inverse relationship between BP and morbidity and mortality. The PARTAGE longitudinal study was performed in 1130 subjects ≥ 80 years living in medical-social institutions. These subjects were receiving at mean 7.1 drugs/day; 2/3 of them were under antihypertensive drugs (mean 2.2 drugs/day). The PARTAGE study showed an over-mortality in hypertensive subjects with low SBP (<130 mmHg) treated with 2 or more antihypertensive drugs. These individuals, who represented 20% of the total studied population, exhibited 80% increase in mortality compared to all other groups, even after adjustment for several comorbidities.
- The recent European guidelines for hypertension indicate that in people ≥ 80 years with SBP≥160 mmHg there is evidence to recommend reducing SBP to between 150 and 140 mmHg. However, no recommendation exists on which strategy to follow if treatment decreases SBP to lower levels (ex: 120 mmHg) especially on the more frail and polymedicated patients of that age. Thus, in this case, physicians can either continue the same treatment of reduce the number of drugs.
- These contrasting results in old hypertensives reflects the enormous functional heterogeneity among individual of this age-group and clearly show that functional status rather than chronological age should guide therapeutic strategies. Thus, the guidelines for robust older individuals cannot be extrapolated to very old, frail individuals, who have been completely excluded from the above-mentioned clinical trials.
The only way is to conduct a controlled clinical trial.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 80 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male and female patients aged 80 and over
- •Patients living in nursing homes
- •Patients with a SBP < 130 mmHg measured in Medical-Social Institutions using the connected blood pressure monitor supplied for the study (average of the last 2 out of 3 measurements after 10 min rest)
- •Hypertensive patients whose treatment contains at least 2 antihypertensive molecules and whose treatment has been stabilised for at least :
- •3 weeks in the case of the introduction or discontinuation of an anti-HBP drug
- •2 weeks in the case of a change in the dosage of one of the anti-HBP drugs.
- •Patients affiliated to a social security scheme
- •Patients who have signed the informed consent form (failing which, the legal representative)
- •Patients with dementia or with a severe reduction in physical function (impaired vision, asthenia, advanced osteoarthritis, severe tremors, etc.) and/or cognitive function may be included in this study with the agreement of their carers or family/relatives.
Exclusion Criteria
- •Patients in whom no antihypertensive molecule can be reduced for specific reasons (heart failure with ejection fraction <40%, fluid retention due to heart failure, coronary artery disease and diabetic nephropathy).
- •Patients with an estimated life expectancy of <3 months
- •Patients who have already been included in this study or in another study at the same time
Arms & Interventions
1: Interventional (drug reduction)
STEP DOWN strategy.
Proposition of reduction of the number of antihypertensive medication according to:
- the systolic blood pressure levels,
- co-morbidities
Intervention: STEP DOWN strategy (Other)
2: Control
Usual treatment
Intervention: Control (Other)
Outcomes
Primary Outcomes
All-cause mortality
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).
All-cause mortality
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).
Secondary Outcomes
- Blood pressure analysis(up to 48 months)
- Evaluation of frailty(up to 48 months)
- Evaluation of cognitive function(up to 48 months)
- Blood pressure analysis(up to 48 months)
- Assesment of fall and fractures(up to 48 months)
- Medication assessment(up to 48 months)
- Patient at high risk of decompensation(up to 48 months)
- Evaluation of frailty(up to 48 months)
- Cause of death(up to 48 months)
- Evaluation of Quality of life(up to 48 months)
- Onset of cardiac decompensation(up to 48 months)
- Evaluation of cognitive function(up to 48 months)