Inappropriate sinus tachycardia MedDRA version: 9.1 Level: LLT Classification code 10003133 Term: Arrythmia sinus
Conditions
Interventions
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 f
Sponsors
POLICLINICO SAN DONATO IRCSS
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. intolerance to ibravadine 2. pregnancy 3. cardiomyopathies 4. other arrhythmias 5. liver or kidney failure or cardiogenic shock
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of ivabradine in patients with inapropriate sinus tachycardia;Secondary Objective: Spectral and symbolic analysis of heart rate variability using ECG Holter monitoring tacograms;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) | — |
Countries
Italy
Outcome results
None listed