Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03453268 |
| Other study ID # |
P160602J |
| Secondary ID |
2017-A01646-47 |
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 2, 2018 |
| Est. completion date |
July 2, 2024 |
Study information
| Verified date |
December 2023 |
| Source |
Assistance Publique - Hôpitaux de Paris |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The investigators hypothesize that a gradual reduction in antihypertensive treatment in
nursing home (NH) 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.
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 nursing homes.
- 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 nursing homes (NHs). 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.
