Clinical trial on the use of ivabradine in patients with inappropriate sinus tachycardia

INTERVENTION: Product Name: Ivabradine Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Ivabradine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use CONDITION: Inappropriate sinus tachycardia ; MedDRA version: 9.1 Level: LLT Classification code 10003133 Term: Arrythmia sinus PRIMARY OUTCOME: Main Objective: To assess the effect of ivabradine in patients with inapropriate sinus tachycardia Primary end point(s): Significant reduction of mean heart rate (< 95 bpm during ECG Holter monitoring and increase < 25 bpm from clino to orthostatic position) Secondary Objective: Spectral and symbolic analysis of heart rate variability using ECG Holter monitoring tacograms INCLUSION CRITERIA: 1. sinus rhythm heart rate ≥ 95 bpm with patients awake 2. an increase in heart rate more than 25 bpm from clino to orthostatic position Are the trial subjects under 18? yes 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range