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Effect of Aliskiren drug in patients with high blood pressure

Effects of Aliskiren on microcirculation dysfunction in patients affected by hypertension

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-002587-24-IT
Enrollment
Unknown
Registered
2012-01-10
Start date
2011-10-20
Completion date
Unknown
Last updated
2012-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dysfunction of coronary microcirculation in arterial hypertension MedDRA version: 14.1 Level: HLT Classification code 10010164 Term: Hypertension complications System Organ Class: 10047065 - Vascular disorders

Interventions

Trade Name: ENALAPRIL S.G.*28CPR 5MG Pharmaceutical Form: Tablet INN or Proposed INN: ENALAPRIL CAS Number: 75847-73-3 Concentration unit: mg milligram(s) Concentration type: equal Concentration numbe

Sponsors

FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: •Age =40 and =75 yr. •Body mass index (BMI) =32 kg/m2; •Diastolic BP (DBP) =65 years) yes F.1.3.1 Number of subjects for this age range 18

Exclusion criteria

Exclusion criteria: • History of secondary HT; • Anamnestic coronary heart disease; • Renal failure (creatinine >1.69 mg/dl or creatinine clearance 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

Design outcomes

Primary

MeasureTime frame
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: -levels of plasma renin activity (PRA) at baseline and at 6 months maximum MBF -delta pressure and delta of myocardial mass indexed (LVMI) -improvement of the indices of systolic-diastolic function of left ventricle and the delta maximum MBF. -delta LVMI and plasma levels of PRA, aldosterone. -No significant correlation between: -delta of maximum pressure and delta MBF (start-end study). -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

MeasureTime frame
Secondary end point(s): -Significant correlation between baseline PRA (or delta PRA M0-M6) and increase of maximun MBF at M6; -No significant correlation between delta (resting or ambulatory) BP levels and delta of maximum MBF; -Significant correlation between delta (resting or ambulatory) BP level and delta of LVMI -No significant correlation between delta LVMI and delta maximum MBF; -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. -Significant correlation between delta LVMI and PRA – aldosterone values.;Timepoint(s) of evaluation of this end point: 6 months—

Countries

Italy

Contacts

Public ContactCardiologia

Fondazione San Raffaele del Monte Tabor

camici.paolo@hsr.it02-26436206

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026