In this study we want to investigate if there is a difference in exposure to losartan and perindopril between younger and elderly patients. Furthermore, the results will enable us to correlate detailed PK data with PD data, which can lead to a more…
ID
Source
Brief title
Condition
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Our primary objective is to determine if there is a difference in exposure to
losartan and perindopril measured with the (AUC) when comparing elderly (>70
years) with younger patients (<50 years).
Secondary outcome
We want to determine if there is a difference in the drop of blood pressure
between older (>70 years) and younger (<50 years) patients; and if so, can this
difference be explained by a difference in the plasma concentration of the
drug. Furthermore, we want to investigate wat the influence is of the AUC on
RAAS-activity during the use of perindopril or losartan. Lastly, we want to
investigate if more parameters, besides age, are of influence on the AUC that
can explain the possible difference.
Background summary
Elderly patients differ from younger patient regarding pharmacokinetics (PK)
and pharmacodynamics (PD). Practically this means that, not only plasma
concentrations after drug intake (PK), but also the effect of the drug can be
different (PD). When treating hypertension, it is assumed that elderly patients
have higher plasma concentrations after intake of the same drug dose than
younger patients. This increase in plasma concentration can lead to adverse
events which could result in non-adherence and consequently suboptimal blood
pressure treatment which leads to increased mortality and morbidity rates.
However, strong evidence to support this conclusion is missing as elderly were
often left out large trials that investigated these antihypertensive drugs.
Furthermore, only little is known about PD changes during ageing; thus more
data on the relation between PK and PD in the elderly are needed.
Study objective
In this study we want to investigate if there is a difference in exposure to
losartan and perindopril between younger and elderly patients. Furthermore, the
results will enable us to correlate detailed PK data with PD data, which can
lead to a more rational dose advice with regard to perindopril and losartan
especially for the elderly patient. These results are needed to start a large
trial to investigate the long term effects of low dose antihypertensive drug
use in elderly
Study design
This is prospective observational study comparing PK/PD from elderly and
younger patients that start with the use of perindopril or losartan. Total
duration of the study can take place within 2 weeks. In the follow-up of four
weeks after the last measurement AEs and SAEs reported by the patient of
physician are collected.
Intervention
Perindopril or losartan use is stopped for 2 weeks to measure baseline blood
pressure without medication. With this the effect of de blood lowering drugs is
measured in a real-life population. Both drugs are restarted after 2 weeks,
unless the treating physiciian decides otherwise.
Study burden and risks
The risk of this study is moderate. However, the visits to the hospital, amount
of finger pricks and 24-h ABPMs can be seen as a burden. This is explained to
the patient before starting the study. Furthermore, losartan and perindopril is
stopped for at least two weeks, as is usual in clinical practice, to measure
blood pressure without the effect of perindopril or losartan. There is a small
chance of adverse events, but patients are informed about this and are asked to
report this to their treating physician or researchers. Also, the treating
physician will monitor these patients closely.
Doctor Molenwaterplein 40
Rotterdam 3015GD
NL
Doctor Molenwaterplein 40
Rotterdam 3015GD
NL
Listed location countries
Age
Inclusion criteria
- Use of oral perindopril 2, 4 or 8 mg a day or losartan 25, 50 or 100 mg a day
or in case of healthy controls willingness to use perindopril 4 mg or losartan
50 mg for five days
- Age between 18-50 years or > 70 years
- Providing informed consent after reading the patient information
- Stopping is in accordance with the treating physician
Exclusion criteria
• Not providing informed consent or not capable of giving informed consent, •
End-stage renal disease (eGFR<15 ml/min) • Use of other antihypertensive drugs
prescribed that are of influence on the RAAS system incuding diuretics, beta
blockers and other RAAS-inhibitors.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2020-003647-28-NL |
| CCMO | NL74782.078.20 |