dc.contributor.author | Abad-Perez, Daniel | |
dc.contributor.author | Novella-Arribas, Blanca | |
dc.contributor.author | Rodríguez-Salvanés, Francisco | |
dc.contributor.author | Sanchez-Gomez, Luis Maria | |
dc.contributor.author | García-Polo, Iluminada | |
dc.contributor.author | Verge-González, Carmen | |
dc.contributor.author | Suárez-Fernández, Carmen | |
dc.date.accessioned | 2018-12-12T12:23:05Z | |
dc.date.available | 2018-12-12T12:23:05Z | |
dc.date.issued | 2013-11-14 | |
dc.identifier.citation | Trials. 2013 Nov 14;14:388. | es_ES |
dc.identifier.issn | 1745-6215 | es_ES |
dc.identifier.uri | http://hdl.handle.net/20.500.12105/6822 | |
dc.description.abstract | BACKGROUND: Isolated systolic hypertension is a highly prevalent disease among the elderly. The little available evidence on the efficacy of nitrates for treating the disease is based on small experimental studies. METHODS/DESIGN: We performed a multicenter, randomized, double-blind, phase III, placebo-controlled trial in 154 patients aged over 65 years with refractory isolated systolic hypertension. Patients were randomized to placebo or 40 mg/day of extended-release isosorbide mononitrate added to standard therapy and titrated to 60 mg/day at week 6 if blood pressure exceeded 140/90 mmHg.The primary objective was to assess the effect on clinical pulse pressure of extended-release isosorbide mononitrate added to standard therapy in patients aged over 65 years with refractory isolated systolic hypertension after 3 months of treatment.The secondary objectives were as follows: to quantify the effect of adding the study drug on central blood pressure and vascular compliance using the augmentation index and pulse wave velocity; to evaluate the safety profile by recording adverse effects (frequency, type, severity) and the percentage of patients who had to withdraw from the trial because of adverse events; to quantify the percentage of patients who reach a clinical systolic blood pressure <140 mmHg or <130 mmHg measured by ambulatory blood pressure monitoring; and to quantify the change in pulse pressure measured by ambulatory blood pressure monitoring. DISCUSSION: Few clinical trials have been carried out to test the effect of oral nitrates on isolated systolic hypertension, even though these agents seem to be effective. Treatment with extended-release isosorbide mononitrate could improve control of systolic blood pressure without severe side effects, thus helping to reduce the morbidity and mortality of the disease. TRIAL REGISTRATION: EUDRACT Number: 2012-002988-10. | es_ES |
dc.description.sponsorship | Funding for the trial was provided by the Ministry of Health, Social Services and Equality (call for the development of independent clinical research, Exp Nº EC11-111). | es_ES |
dc.language.iso | eng | es_ES |
dc.publisher | BioMed Central (BMC) | es_ES |
dc.type.hasVersion | VoR | es_ES |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ | * |
dc.subject | Hypertension | es_ES |
dc.subject | Nitrates | es_ES |
dc.subject | Older people | es_ES |
dc.subject | Systolic-hypertension | es_ES |
dc.subject.mesh | Administration, Oral | es_ES |
dc.subject.mesh | Aged | es_ES |
dc.subject.mesh | Antihypertensive Agents | es_ES |
dc.subject.mesh | Blood Pressure | es_ES |
dc.subject.mesh | Blood Pressure Monitoring, Ambulatory | es_ES |
dc.subject.mesh | Clinical Protocols | es_ES |
dc.subject.mesh | Delayed-Action Preparations | es_ES |
dc.subject.mesh | Double-Blind Method | es_ES |
dc.subject.mesh | Elasticity | es_ES |
dc.subject.mesh | Humans | es_ES |
dc.subject.mesh | Hypertension | es_ES |
dc.subject.mesh | Isosorbide Dinitrate | es_ES |
dc.subject.mesh | Pulse Wave Analysis | es_ES |
dc.subject.mesh | Spain | es_ES |
dc.subject.mesh | Time Factors | es_ES |
dc.subject.mesh | Treatment Outcome | es_ES |
dc.subject.mesh | Vascular Stiffness | es_ES |
dc.subject.mesh | Vasodilator Agents | es_ES |
dc.subject.mesh | Research Design | es_ES |
dc.title | Effect of oral nitrates on pulse pressure and arterial elasticity in patients aged over 65 years with refractory isolated systolic hypertension: study protocol for a randomized controlled trial | es_ES |
dc.type | journal article | es_ES |
dc.rights.license | Atribución 4.0 Internacional | * |
dc.identifier.pubmedID | 24228894 | es_ES |
dc.format.volume | 14 | es_ES |
dc.format.number | 1 | es_ES |
dc.format.page | 388 | es_ES |
dc.identifier.doi | 10.1186/1745-6215-14-388 | es_ES |
dc.contributor.funder | Ministerio de Sanidad, Servicios Sociales e Igualdad (España) | |
dc.description.peerreviewed | Sí | es_ES |
dc.identifier.e-issn | 1745-6215 | es_ES |
dc.relation.publisherversion | https://doi.org/10.1186/1745-6215-14-388 | es_ES |
dc.identifier.journal | Trials | es_ES |
dc.repisalud.centro | ISCIII::Agencia de Evaluación de Tecnologías Sanitarias | es_ES |
dc.repisalud.institucion | ISCIII | es_ES |
dc.rights.accessRights | open access | es_ES |