The purpose of this study is 1. to compare the effects of nifedipine GITS and ramipril on blood pressure variability in subjects with elevated blood pressure variability. 2. to assess whether the degree of treatment-induced changes in blood pressure variability, is related to the degree of regression (or progression) of organ damage in heart, kidneys and carotid arteries.
Elevated blood pressure variability (BPV) is associated with adverse cardiovascular outcomes and organ damage in hypertensive subjects. An antihypertensive treatment able to reduce BPV independently of BP lowering effect might thus provide additional protection in terms of cardiovascular risk in subjects with elevated BPV, independently on its effect of BP itself. However, data on the effects of different classes of antihypertensive drugs on BPV are limited and inconsistent. Some studies have suggested a possible usefulness of calcium antagonists in this setting. Based on the above considerations the investigators hypothesize that a calcium channel blocker nifedipine GITS, will provide a greater BPV lowering effect, when compared with ramipril, independently from the reduction in mean BP level. Based on the above considerations, the primary objective of this study is to compare the effects of nifedipine GITS and ramipril on different estimates of BPV (24 h BPV, home BPV, and visit-to-visit BPV) in subjects with elevated BPV. The secondary objective is to assess whether the degree of treatment-induced changes in BPV, is related to the degree of regression (or progression) of organ damage, after accounting for mean BP reduction by treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
168
Commercially available drug formulations are used. Study medication will be assumed in a single morning (7-10 a.m.) administration per os.
Commercially available drug formulations are used. Study medication will be assumed in a single morning (7-10 a.m.) administration per os.
Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital Shanghai Institute of Hypertension, Shanghai Jiaotong University School of Medicine
Shanghai, China
Hypertension Center, Third University Department of Medicine, Sotiria Hospital
Athens, Greece
Istituto Auxologico Italiano
Milan, Italy
Variability (standard deviation) of home systolic blood pressure at final visit
Time frame: After 10 weeks of study treatment
Variability (standard deviation) of home diastolic blood pressure measured at final visit
Time frame: At baseline and after 10 weeks of study treatment
Short term 24h variability of systolic blood pressure at final visit (24h weighted standard deviation)
Time frame: At baseline and after 10 weeks of study treatment
Short term 24h variability of diastolic blood pressure at final visit (24h weighted standard deviation)
Time frame: At baseline and after 10 weeks of study treatment
Visit-to-visit variability (standard deviation) of systolic blood pressure assessed over the three last visits
Time frame: At baseline and after 6, 8 and 10 weeks of study treatment
Visit-to-visit variability (standard deviation) of diastolic blood pressure assessed over the three last visits
Time frame: At baseline and after 6, 8 and 10 weeks of study treatment
Mean 24 hour systolic blood pressure at final visit
Time frame: At baseline and after 10 weeks of study treatment
Mean 24 hour diastolic blood pressure at final visit
Time frame: At baseline and after 10 weeks of study treatment
Sokolow index at the end of the extension study
Time frame: At baseline and after 12 months of study treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cornell voltage duration index at the end of the extension study
Time frame: At baseline and after 12 months of study treatment
Left ventricular mass index at the end of the extension study
Time frame: At baseline and after 12 months of study treatment
Microalbuminuria (albumin-creatinine ratio) at the end of the extension study
Time frame: At baseline and after 12 months of study treatment
Estimated glomerular filtration rate (eGFR, by CKD-EPI formula) at the end of the extension study
Time frame: At baseline and after 12 months of study treatment
Carotid-femoral pulse wave velocity (cfPWV) at the end of the extension study
Time frame: At baseline and after 12 months of study treatment