REducing blood pressure Variability in Essential hypertension with RAmipril vErsus Nifedipine GITS Trial - REVERENT

Istituto Auxologico Italiano, IRCCS0 个研究点目标入组 168 人开始时间: 2014年10月23日最近更新: 2020年11月30日

适应症

试验速览

暂无简介。

•- Male and female subjects
•- Age 35-75 years
•- clinic systolic (SBP) =140 mmHg and/or diastolic blood pressure (DBP) = 90 mmHg
•- daytime blood pressure (BP) on ambulatory BP monitoring (ABPM) =135 mmHg systolic and/or =85 mmHg diastolic
•- home SBP standard deviation (SD) >7 mmHg and/or daytime ambulatory SBP SD >12 mmHg
•- patients may be included if untreated or, if treated with one antihypertensive drug or two drugs in low doses, after 2 weeks’ washout period
•- written informed consent to participate in the study
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 100
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 68

•- subjects treated with = 2 antihypertensive drugs (except those on two drugs in low doses)
•- treated subjects with on-treatment clinic BP =160 mmHg systolic and/or 100 mmHg diastolic
•- treated antihypertensive subjects in whom withdrawal of treatment is deemed unethical for other reasons
•- Contraindications to study treatments as detailed in the relative Summaries of medical Product Characteristics for ramipril or nifedipine GITS (this includes hypersensitivity, pregnancy and lactation)
•- Cardiovascular diseases other than hypertension
•- Suspected or confirmed secondary hypertension
•- Diabetes mellitus
•- Other conditions deemed relevant by the investigator
•- BMI =35 kg/m2
•- known severe obstructive sleep apnea
•- Premenopausal women not using effective contraceptive methods
•- Elevated probability of noncompliance with the study procedures

发起方

Istituto Auxologico Italiano, IRCCS