EARLY Treatment with azilsartan compared to ACE-inhibitors in anti-hypertensive therapy--rationale and design of the EARLY hypertension registry
Autor: | Anselm K, Gitt, Peter, Baumgart, Peter, Bramlage, Felix, Mahfoud, Sebastian A, Potthoff, Jochen, Senges, Steffen, Schneider, Hartmut, Buhck, Roland E, Schmieder, Reinhold, Hübner |
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Rok vydání: | 2013 |
Předmět: |
Ramipril
ACE-Inhibitors medicine.medical_specialty Non-Interventional Time Factors Medizinische Fakultät -ohne weitere Spezifikation Central Systolic Blood Pressure Azilsartan Angiotensin-Converting Enzyme Inhibitors Blood Pressure law.invention Study Protocol Randomized controlled trial Double-Blind Method law Internal medicine medicine Humans Azilsartan Medoxomil ddc:610 Prospective Studies Registries Intensive care medicine Prospective cohort study Antihypertensive Agents Oxadiazoles business.industry Follow-up Clinical trial Blood pressure Treatment Outcome Ambulatory Blood Pressure Measurement ACE inhibitor Hypertension Benzimidazoles business Cardiology and Cardiovascular Medicine medicine.drug Follow-Up Studies |
Zdroj: | BMC Cardiovascular Disorders |
ISSN: | 1471-2261 |
Popis: | Background Arterial hypertension is highly prevalent but poorly controlled. Blood pressure (BP) reduction substantially reduces cardiovascular morbidity and mortality. Recent randomized, double-blind clinical trials demonstrated that azilsartan medoxomil (AZM) is more effective in reducing BP than the ubiquitary ACE inhibitor ramipril. Therefore, we aimed to test whether these can be verified under clinical practice conditions. Methods/Design The “Treatment with Azilsartan Compared to ACE-Inhibitors in Anti-Hypertensive Therapy” (EARLY) registry is a prospective, observational, national, multicenter registry with a follow-up of up to 12 months. It will include up to 5000 patients on AZM or ACE-inhibitor monotherapy in a ratio of 7 to 3. A subgroup of patients will undergo 24-hour BP monitoring. EARLY has two co-primary objectives: 1) Description of the safety profile of azilsartan and 2) achievement of BP targets based on recent national and international guidelines for patients treated with azilsartan in comparison to those treated with ACE-inhibitors. The most important secondary endpoints are the determination of persistence with treatment and the documentation of cardiovascular and renal events. Recruitment commenced in January 2012 and will be completed by February 2013. Conclusions The data obtained will supplement previous results from randomized controlled trials to document the potential value of utilizing azilsartan medoxomil in comparison to ACE-inhibitor treatment for target BP achievement in clinical practice. |
Databáze: | OpenAIRE |
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