A randomised, placebo controlled, double blind, cross-over, single center clinical Study to investigate the effect of heart rate reduction with ivabradine on endothelial function and vascular stiffness in patients with stable coronary heart disease.

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2012
INTERVENTION: Trade Name: Procoralan® Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: IVABRADINE CAS Number: 155974‐00‐8 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 7.5‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use CONDITION: Stable coronary heart disease. ; MedDRA version: 14.1 Level: LLT Classification code 10068617 Term: Coronary heart disease System Organ Class: 10007541 ‐ Cardiac disorders Therapeutic area: Diseases [C] ‐ Cardiovascular Diseases [C14] PRIMARY OUTCOME: 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. Primary end point(s): ‐Aortic distensibility ; ‐Pulse wave velocity ; ‐Brachial endothelial function; Secondary Objective: No secondary objectives Timepoint(s) of evaluation of this end point: Evaluation of all avove mentioned Endpoints at:; ‐Baseline; ‐Months 6 ; ‐Month 12 SECONDARY OUTCOME: Secondary end point(s): No Timepoint(s) of evaluation of this end point: Serum and Plasma markers for oxidative stress and inflammation INCLUSION CRITERIA: ‐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
Epistemonikos ID: 68a3b26413d0c9105e5ac10011e36cc83d608cd7
First added on: Aug 22, 2024