Effect of Aliskiren drug in patients with high blood pressure

Conditions: dysfunction of coronary microcirculation in arterial hypertension
MedDRA version: 14.1Level: HLTClassification code 10010164Term: Hypertension complicationsSystem Organ Class: 10047065 - Vascular disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2011-002587-24-IT

Lead Sponsor: FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

•Age =40 and =75 yr.
•Body mass index (BMI) =32 kg/m2;
•Diastolic BP (DBP) <110 mmHg and systolic BP (SBP) <180 mmHg in patients previously treated;
•On therapy with amlodipine with or without a thiazide diuretic;
•Left ventricular mass index (LVMI) =115 g/m2 (men) or =100 g/m2 (women) quantified by two dimensional echocardiography;
•Left ventricular ejection fraction =55% at two-dimensional echocardiography;
•Valid informed consent obtained from participants.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18

Exclusion Criteria

•History of secondary HT;
•Anamnestic coronary heart disease;
•Renal failure (creatinine >1.69 mg/dl or creatinine clearance <30 ml/min);
•Hypokalemia (<3.4 mEq/l) or hyperkalemia (>5 mEq/l);
•Insulin-dependent diabetes;
•Significant valvular disease or left ventricular systolic dysfunction at echocardiography;
•Treatment with Aliskiren, ACE inhibitors or angiotensin receptor blockers in the month preceding the first selection visit;
•Patients with stress-induced regional perfusion defects at PET will be referred for coronary angiography and excluded from the study if they have coronary artery disease;
•Pregnancy and breastfeeding;
•ACEI angioedema, hereditary and/or idiopathic angioedema;
•Severe hepatic dysfunction

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to evaluate the effect of aliskiren compared to enelapril in improving myocardial blood pressure in patients with hypertensive heart disease;Secondary Objective: Significant correlation between:<br>-levels of plasma renin activity (PRA) at baseline and at 6 months maximum MBF<br>-delta pressure and delta of myocardial mass indexed (LVMI)<br>-improvement of the indices of systolic-diastolic function of left ventricle and the delta maximum MBF.<br>-delta LVMI and plasma levels of PRA, aldosterone.<br>-No significant correlation between:<br>-delta of maximum pressure and delta MBF (start-end study).<br>-maximum delta-delta LVMI and MBF.;Primary end point(s): Significant difference (=0.5 ml/min/g) in maximum MBF between the two treatment groups.;Timepoint(s) of evaluation of this end point: 6 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -Significant correlation between baseline PRA (or delta PRA M0-M6) and increase of maximun MBF at M6;<br>-No significant correlation between delta (resting or ambulatory) BP levels and delta of maximum MBF;<br>-Significant correlation between delta (resting or ambulatory) BP level and delta of LVMI<br>-No significant correlation between delta LVMI and delta maximum MBF;<br>-Significant correlation between improvement of diastolic or systolic markers of LV dysfunction (LV stiffness, E/A ratio , E/Em ratio or TEI index) and delta maximum MBF.<br>-Significant correlation between delta LVMI and PRA – aldosterone values.;Timepoint(s) of evaluation of this end point: 6 months