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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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The purpose of this study is
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nifedipine GITS 30 mg slow release | Experimental | Nifedipine GITS 30 mg slow release in tablets. |
|
| Ramipril 10 mg | Experimental | Ramipril 10 mg in tablets. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nifedipine GITS | Drug | Commercially available drug formulations are used. Study medication will be assumed in a single morning (7-10 a.m.) administration per os. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Variability (standard deviation) of home systolic blood pressure at final visit | After 10 weeks of study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Variability (standard deviation) of home diastolic blood pressure measured at final visit | At baseline and after 10 weeks of study treatment | |
| Short term 24h variability of systolic blood pressure at final visit (24h weighted standard deviation) | At baseline and after 10 weeks of study treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gianfranco Parati, MD | Istituto Auxologico Italiano - Milan, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital Shanghai Institute of Hypertension, Shanghai Jiaotong University School of Medicine | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23817082 | Background | Mancia G, Fagard R, Narkiewicz K, Redon J, Zanchetti A, Bohm M, Christiaens T, Cifkova R, De Backer G, Dominiczak A, Galderisi M, Grobbee DE, Jaarsma T, Kirchhof P, Kjeldsen SE, Laurent S, Manolis AJ, Nilsson PM, Ruilope LM, Schmieder RE, Sirnes PA, Sleight P, Viigimaa M, Waeber B, Zannad F; Task Force Members. 2013 ESH/ESC Guidelines for the management of arterial hypertension: the Task Force for the management of arterial hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertens. 2013 Jul;31(7):1281-357. doi: 10.1097/01.hjh.0000431740.32696.cc. No abstract available. | |
| 23399972 |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017257 | Ramipril |
| ID | Term |
|---|---|
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Ramipril | Drug | Commercially available drug formulations are used. Study medication will be assumed in a single morning (7-10 a.m.) administration per os. |
|
| Short term 24h variability of diastolic blood pressure at final visit (24h weighted standard deviation) | 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 | 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 | At baseline and after 6, 8 and 10 weeks of study treatment |
| Mean 24 hour systolic blood pressure at final visit | At baseline and after 10 weeks of study treatment |
| Mean 24 hour diastolic blood pressure at final visit | At baseline and after 10 weeks of study treatment |
| Sokolow index at the end of the extension study | At baseline and after 12 months of study treatment |
| Cornell voltage duration index at the end of the extension study | At baseline and after 12 months of study treatment |
| Left ventricular mass index at the end of the extension study | At baseline and after 12 months of study treatment |
| Microalbuminuria (albumin-creatinine ratio) at the end of the extension study | 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 | At baseline and after 12 months of study treatment |
| Carotid-femoral pulse wave velocity (cfPWV) at the end of the extension study | At baseline and after 12 months of study treatment |
| Hypertension Center, Third University Department of Medicine, Sotiria Hospital | Athens | Greece |
| Istituto Auxologico Italiano | Milan | Italy |
| Background |
| Parati G, Ochoa JE, Lombardi C, Bilo G. Assessment and management of blood-pressure variability. Nat Rev Cardiol. 2013 Mar;10(3):143-55. doi: 10.1038/nrcardio.2013.1. Epub 2013 Feb 12. |
| 14508204 | Background | Liu JG, Xu LP, Chu ZX, Miao CY, Su DF. Contribution of blood pressure variability to the effect of nitrendipine on end-organ damage in spontaneously hypertensive rats. J Hypertens. 2003 Oct;21(10):1961-7. doi: 10.1097/00004872-200310000-00025. |
| 20226988 | Background | Rothwell PM, Howard SC, Dolan E, O'Brien E, Dobson JE, Dahlof B, Sever PS, Poulter NR. Prognostic significance of visit-to-visit variability, maximum systolic blood pressure, and episodic hypertension. Lancet. 2010 Mar 13;375(9718):895-905. doi: 10.1016/S0140-6736(10)60308-X. |
| 20226989 | Background | Webb AJ, Fischer U, Mehta Z, Rothwell PM. Effects of antihypertensive-drug class on interindividual variation in blood pressure and risk of stroke: a systematic review and meta-analysis. Lancet. 2010 Mar 13;375(9718):906-15. doi: 10.1016/S0140-6736(10)60235-8. |
| 24843686 | Background | Ushigome E, Fukui M, Hamaguchi M, Tanaka T, Atsuta H, Ohnishi M, Oda Y, Yamazaki M, Hasegawa G, Nakamura N. Beneficial effect of calcium channel blockers on home blood pressure variability in the morning in patients with type 2 diabetes. J Diabetes Investig. 2013 Jul 8;4(4):399-404. doi: 10.1111/jdi.12052. Epub 2013 Mar 4. |
| 24685006 | Background | Wang JG, Yan P, Jeffers BW. Effects of amlodipine and other classes of antihypertensive drugs on long-term blood pressure variability: evidence from randomized controlled trials. J Am Soc Hypertens. 2014 May;8(5):340-9. doi: 10.1016/j.jash.2014.02.004. Epub 2014 Feb 15. |
| 24671016 | Background | Levi-Marpillat N, Macquin-Mavier I, Tropeano AI, Parati G, Maison P. Antihypertensive drug classes have different effects on short-term blood pressure variability in essential hypertension. Hypertens Res. 2014 Jun;37(6):585-90. doi: 10.1038/hr.2014.33. Epub 2014 Mar 27. |
| 22499291 | Background | Mancia G, Facchetti R, Parati G, Zanchetti A. Visit-to-visit blood pressure variability in the European Lacidipine Study on Atherosclerosis: methodological aspects and effects of antihypertensive treatment. J Hypertens. 2012 Jun;30(6):1241-51. doi: 10.1097/HJH.0b013e32835339ac. |
| 22547439 | Background | Matsui Y, O'Rourke MF, Hoshide S, Ishikawa J, Shimada K, Kario K. Combined effect of angiotensin II receptor blocker and either a calcium channel blocker or diuretic on day-by-day variability of home blood pressure: the Japan Combined Treatment With Olmesartan and a Calcium-Channel Blocker Versus Olmesartan and Diuretics Randomized Efficacy Study. Hypertension. 2012 Jun;59(6):1132-8. doi: 10.1161/HYPERTENSIONAHA.111.189217. Epub 2012 Apr 30. |
| 39657776 | Derived | Zhang W, Liu CY, Bilo G, Soranna D, Zambon A, Kyriakoulis KG, Kollias A, Ceravolo I, Cassago S, Pengo MF, Destounis A, Stergiou GS, Wang JG, Parati G. A Randomized Controlled Trial on the Efficacy and Safety of a Calcium-Channel Blocker and an Angiotensin-Converting Enzyme Inhibitor in Chinese and European Patients with Hypertension. Am J Hypertens. 2025 Mar 17;38(4):248-256. doi: 10.1093/ajh/hpae152. |