Determination of the improvement of impaired endothelial function and endothelial progenitor cell numbers following treatment with Aliskiren 300 mg in patients with coronary artery disease and hypertension. MedDRA version: 14.0 Level: PT Classification code 10020772 Term: Hypertension System Organ Class: 10047065 - Vascular disorders MedDRA version: 14.0 Level: PT Classification code 10011078 Term: Coronary artery disease System Organ Class: 10007541 - Cardiac disorders
Conditions
Sponsors
Universitätsklinikum Würzburg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Hypertension (systolic RR >140 mmHg) • Established coronary artery disease (based on invasive coronary angiography) • Ensured compliance: patient should be able to cooperate with protocol regimen and follow-up • female patients must be post-menopausal. Post-menopausal and not of child-bearing potential females are defined as females who have had: o = 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or o = 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/ml or o surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment. 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 6 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: • Age below 18 years and over 85 years. • Pregnancy or breast-feeding • Unstable Angina pectoris or within 3 months after myocardial infarction • Coronary stent implantation within the last 3 months • Heart failure NYHA III and IV • Patients who cannot come to revisits • Current infections • Patients with life expectancy below 12 months • Alcohol or drug abuse within the last 5 years • Creatinine > 2.5 mg/dl • GFR= 30 (ml/min) / 1.73 m² • Hyperkalemia > 5 mmol/l • Actual or anamnestic cerebrovascular events • Hypotension • Angio-oedema related to inhibitors of the renin-angiotensin-system in the medical history • Hypersensitivity to the active substance • Simultaneous administration of Aliskiren and Ciclosporin ( a high efficient P-gp-Inhibitor) and other efficient P-gp-Inhibitors (Chinidin, Verapamil) • Combination therapy with ACE inhibitor and ARBs • Therapy with aldosterone antagonists • No stable dose of statins, beta blockers and ACE inhibitors or ARB for 4 weeks prior to Visit 1. • Any medication with major impact on endothelial function such as carvediolol, nebivolol, monoxidin, long lasting nitrate preparations, alcohol, caffeine, PDE5 inhibitors not discontinued for at least 24 hours before measurements. • Participation in another clinical trial within 30 days before study start or during the trial. • Participation of patient who might be dependent on the investigator, also the spouce, parents or children.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary aim is to test for changes in endothelial function, endothelial progenitor cell number and migratory capacity (functional test) after 8 weeks of Aliskiren treatment (300 mg)and also to determine an improvement in vascular performance (digital pulse volume). ;Secondary Objective: Secondary objectives are to assess changes of the quality of life, blood pressure, basic blood parameters and markers of nitric oxide bioavailability (asymmetric dimethylarginine (ADMA), cyclic GMP, as well as markers for reactive oxygen species). ;Primary end point(s): The primary aim is to test for changes in endothelial function, endothelial progenitor cell number and migratory capacity (functional test) after 8 weeks of Aliskiren treatment (300 mg). Primary end points: • Endothelial function (augmentation index, arterial stiffness) • Endothelial progenitor cell number • Endothelial progenitor cell migratory capacity ;Timepoint(s) of evaluation of this end point: Time point for each of the primary end points are baseline visit, week 2 and week 8. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary aim is to test for changes in quality of life, blood pressure, blood parameters, markers of nitric oxide bioavailability, such as asymmetric dimethylarginine (ADMA), cyclic GMP, as well as markers for reactive oxygen species.;Timepoint(s) of evaluation of this end point: Time point for each of the secondary end points are baseline visit, week 2 and week 8 (except for quality of life - only baseline and week 8). | — |
Countries
Germany
Contacts
Public ContactMonika Haken
CROLLL GmbH
Outcome results
None listed