Clinical study to investigate the effect of heart rate reduction with the drug ivabradine on the function of large blood vessels in patients with angina pectoris (coronary heart disease).
- Conditions
- Stable coronary heart disease.MedDRA version: 14.1Level: LLTClassification code 10068617Term: Coronary heart diseaseSystem Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2012-001989-15-DE
- Lead Sponsor
- niversität des Saarlandes
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
-Male and female patients
-Age > 18 years old
-Resting heart rate = 70 bpm
-Sinus rhythm
-Chronic stable angina pectoris
-Coronary heart disease detected by coronary angiography
-Written informed consent to participate in the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15
-Acute coronary syndrome / myocardial infarction
-CAD treated best by surgical coronary bypass grafting
-Stroke / TIA
-Resting heart rate < 70/min
-Indwelling pacemaker, AICD, metallic implants
-Valvular heart disease with indication for surgical intervention
-Caridac rhythm other than sinus
-Uncontrolled arterial hypertension
-Preexisting medication with study drug
-Symptomatic PAD
-Known diabetes mellitus
-Pre-menopausal women
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To test the hypothesis that heart rate reduction induced by the I(f)-channel inhibitor ivabradine improves endothelial function and central vascular compliance in patients with chronic stable coronary artery disease. ;Secondary Objective: No secondary objectives;Primary end point(s): -Aortic distensibility <br>-Pulse wave velocity <br>-Brachial endothelial function<br>;Timepoint(s) of evaluation of this end point: Evaluation of all avove mentioned Endpoints at:<br>-Baseline<br>-Months 6 <br>-Month 12
- Secondary Outcome Measures
Name Time Method Secondary end point(s): No;Timepoint(s) of evaluation of this end point: Serum and Plasma markers for oxidative stress and inflammation