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Single-center, Randomized, Open-label, Parallel-group Study to Characterize Renin-angiotensin-system (RAS) Peptide Profiles Before and After Treatment Initiation With Different Antihypertensive Drug-classes in Patients With Treatment-naive Arterial Hypertension
Randomized, open-label, parallel-group study conducted at a single center in Switzerland. Patients diagnosed with primary arterial hypertension requiring antihypertensive drug Treatment as well as patients after a 4 week wash out period (Amendment 07/2016) will be recruited at the University Hospital Basel, Switzerland. Subjects will be randomized to either the angiotensin-converting enzyme inhibitor-, angiotensin receptor blocker-, calcium channel blocker- or hydrochlorothiazide-treatment arm. Drug treatment follows current guidelines issued by the European Society of Hypertension. Treatment-naive patients will be started on an intermediate dose monotherapy (treatment period 1). In all patients who do not reach blood pressure targets after 4 weeks, the dose of the monotherapy drug will be doubled (high dose, treatment period 2). Sampling for the analysis of RAS peptide profiles, measurement of drug concentrations in plasma and non-invasive hemodynamic measurements will be done. A control group with 20 age and gender matched, healthy and normotensive subjects will be recruited to establish the characteristics of the RAS peptide profiles in a comparable but normotensive population.
Details
| Lead sponsor | Insel Gruppe AG, University Hospital Bern |
|---|---|
| Status | COMPLETED |
| Enrolment | 107 |
| Start date | 2015-04 |
| Completion | 2018-11 |
Conditions
- Essential Hypertension
Interventions
- Perindopril
- Olmesartan
- Amlodipine
- Hydrochlorothiazide
Primary outcomes
- RAS peptide profiles — 0h and 4h
Concentration measurement of the different RAS peptides
Countries
Switzerland