Refractory isolated systolic hypertension
Conditions
Interventions
Trade Name: CARDIONIL 20 mg cápsulas de liberación prolongada
Pharmaceutical Form: Capsule
INN or Proposed INN: 5-mononitrato de isosorbida (D.C.I.), 20 mg
Current Sponsor code: CARDIONIL 20 mg cápsul
Sponsors
Fundación para la investigacion Biomedica
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 154
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effect on clinic pulse pressure of extended release isosorbide mononitrate vs placebo, added to the usual treatment of patients over 65 with refractory ISH, after 3 months of treatment.;Secondary Objective: 1.- To quantify the effect on vascular function (estimated by central BP, augmentation index and pulse wave velocity) of extended release isosorbide mononitrate vs placebo, after 3 months of treatment. 2.- To compare the effect of the addition of extended releasese isosorbide mononitrate on previous parameters, depending on whether HT is truly refractory (mean 24 hour BP >130/80 mmHg) or pseudorefractory (?130/80 mmHg) 3.- To evaluate the safety profile of the strategy based on the addition of extended release isosorbide mononitrate, by the appearance of adverse effects (with particular attention to headache and orthostatic hypotension). 4.- To quantify the percentage of patients that reach a clinic sistolyc blood pressure <140mmHg in both treatments groups;Primary end point(s): - Difference between PP final visit and PP baseline visit: mmHg (office);Timepoint(s) of evaluation of this end point: The primary efficacy assessment will be the difference between PP in the last visit compared to PP in the screening visit, and it will be demonstrated significantly differences compared to placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Difference between SBP( Systolic Blood Pressure)baseline visit and SBP final visit: mmHg (office) - Difference between DBP(Diastolic Blood Pressure) baseline visit and DBP final visit: mmHg (office) - Difference between PP(Pulse Pressure) baseline visit and PP final visit: mmHg (24 hours mean at ABPM,Ambulatory Blood Pressure Monitoring) - Difference between SBP baseline visit and SBP final visit: mmHg (24 hours mean at ABPM) - Difference between DBP baseline visit and DBP final visit: mmHg (24 hours mean at ABPM) - Difference between PWV baseline(Pulse Wave Velocity) visit and PWV final visit - Difference between Central SBP baseline visit and central SBP final visit - Difference between Central PP baseline visit and central PP final visit - Difference between AI baseline visit and AI final visit - Percentage of subjects with SBP10 mmHg at office - Percentage of subjects with adverse effects and type of adverse effect at 6 and 12 weeks after intervention - Percentage of subjects that must abandon the study due to adverse effects. - Percentage of patients with orthostatic hypotension (a decrease on SBP >20mmHg and/or DBP >10mmHg after one minute of standing) at each one of the visits;Timepoint(s) of evaluation of this end point: All of secondary objectives will be measured as the difference between the last visit compared to the inclusion visit. | — |
Countries
Spain
Contacts
Public ContactRafael Fernandez
Fundacion para la investigacion biomedica
Outcome results
None listed