Randomized, double-blind, placebo-controlled trial to compare the effect, three months of follow-on pulse pressure and vascular function of isosorbide mononitrate extended release, associated with antihypertensive treatment in patients over 65 years refractory isolated systolic hypertension.

Phase 1

Conditions: Refractory isolated systolic hypertension
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2012-002988-10-ES

Lead Sponsor: Fundación para la investigacion Biomedica

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

?Patients aged 65 or over of both genders, belong to some primary care or Hypertension?s Unit of Hospital La Princesa, who will be given their written informed consent to participate in the study.
?Patients with refractory ISH defined as SBP ?140 mmHg and DBP <90 mmHg, despite treatment with three drugs as maximum doses, one of them diuretic, during at least one month before the start
?Good adherence to treatment, defined as a good response to all questions of Morisky-Green?s test.
?SBP between 140 y 179 mmHg
?Ability to understand study procedures and to comply with them for the entire length of the study.
?Life expectancy greater than 1 year
?Signing the informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 154

Exclusion Criteria

?Current treatment with nitrites or intolerance to them
?Atrial fibrillation
?Secondary hypertension
?Patients with physical, mental or important communications limitations.
?life expectancy less than one year
?Malignancy
?Congestive heart failure III-IV NYHA
?Renal failure IV-V (glomerular filtration measured with MDRD ?30 ml/min)
?Hepatic failure
?Concomitant treatment with phosphodiesterase 5 during previous month at the beginning of study
?Severe anaemia (haemoglobin ?8g/dl)
?Simultaneous participation in another clinical trial.
?Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
?Subjects who don?t give their written consent to participate in the study.
?Any other circumstance that, as the researcher criteria, advises against the inclusion to the study