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

Table 1 Inclusion and exclusion criteria

Inclusion criteria	Exclusion criteria
Aged 65 or over	Current treatment with nitrates, intolerance to them or contraindication to their use
Refractory ISH: SBP ≥140 mmHg and DBP <90 mmHg and SBP in ABPM ≥130 mmHg, despite treatment with three drugs at maximum dosage, one of them diuretic, during at least one month before the start	Concomitant treatment with phosphodiesterase 5 inhibitors
	SBP ≥180 mmHg
Good adherence to treatment, defined as a good response to all questions of Morisky-Green’s test	Permanent atrial fibrillation
	Secondary hypertension
Life expectancy greater than 1 year	Congestive heart failure, grade III-IV NYHA
Signing the informed consent	Chronic kidney disease with glomerular filtration rate ≤30 ml/min, estimated by MDRD
Ability to understand study procedures and to comply with them for the entire length of the study
	Liver insufficiency
	Active cancer
	Anemia ≤8 g/dl
	Simultaneous participation in another clinical trial
	Not signing the informed consent
	Any other circumstance that, according to the research criteria, advises against the inclusion to the study

Patients are included if they meet all the inclusion criteria and none of the exclusion criteria.
ABPM: ambulatory blood pressure monitoring, DBP: diastolic blood pressure, ISH: isolated systolic hypertension, NYHA: New York heart association, MDRD: modification of diet in renal disease, SBP: systolic blood pressure.

ISSN: 1745-6215