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

• Published in: Trials Vol. 14; no. 1; p. 388
• Main Authors: Abad-Pérez, Daniel, Novella-Arribas, Blanca, Rodríguez-Salvanés, Francisco J, Sánchez-Gómez, Luis M, García-Polo, Iluminada, Verge-González, Carmen, Suárez-Fernández, Carmen
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 14.11.2013; BioMed Central
• Subjects: Administration, Oral; Aged; Antihypertensive Agents - administration & dosage; Arteries; Blood pressure; Blood Pressure - drug effects; Blood Pressure Monitoring, Ambulatory; Care and treatment; Clinical Protocols; Delayed-Action Preparations; Diagnosis; Dosage and administration; Double-Blind Method; Elasticity; Health aspects; Humans; Hypertension; Hypertension - diagnosis; Hypertension - drug therapy; Hypertension - physiopathology; Isosorbide Dinitrate - administration & dosage; Isosorbide Dinitrate - analogs & derivatives; Isosorbide mononitrate; Measurement; Mortality; Nitrates; Physiological aspects; Pulse Wave Analysis; Research Design; Spain; Study Protocol; Time Factors; Treatment Outcome; Vascular Stiffness - drug effects; Vasodilator Agents - administration & dosage; Wave propagation; Spain
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/1745-6215-14-388

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. 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. 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. EUDRACT Number: 2012-002988-10.