INTENSIFY: PractIcal daily effectiveNess and TolEraNce of Procoralan® in chronic SystolIc heart Failure in GermanY: An observational prospective multicentre study

Servier Deutschland GmbH (Germany)0 个研究点目标入组 3,570 人开始时间: 2012年6月19日最近更新: 2019年2月11日

适应症

试验速览

•1. Adult patients (male, female) with chronic systolic heart insufficiency
•2. New York Heart Association (NYHA)-Class II-IV, with resting heart rate superior or equal to 75

•1. Does not meet inclusion criteria
•2. Investigators should follow the Summary of Product Specifications (SmPC) of Procoralan®, which include the following contraindications:
•2.1. Hypersensitivity to the active substance or to any of the excipients
•2.2. Resting heart rate below 60 beats per minute prior to treatment
•2.3. Cardiogenic shock
•2.4. Acute myocardial infarction
•2.5. Severe hypotension (< 90/50 mmHg)
•2.6. Severe hepatic insufficiency
•2.7. Sick sinus syndrome
•2.8. Sino-atrial block
•2.9. Unstable or acute heart insufficiency
•2.10. Pacemaker dependent
•2.11. Unstable angina
•2.12. Atrioventricular (AV) block of 3rd degree
•2.13. Combination with strong cytochrome P450 3A4 inhibitors such as azole antifungals (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, erythromycin per os, josamycin, telithromycin), Human immunodeficiency virus (HIV) protease inhibitors (nelfinavir, ritonavir) and nefazodone
•2.14. Pregnancy, lactation

发起方

Servier Deutschland GmbH (Germany)