Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-24 @ 11:07 PM
NCT ID:
NCT02687269
Eligibility Criteria:
Inclusion Criteria:
* age ≥ 18 years
* sinus rhythm, heart rate (FC) ≥ 50 bpm at rest;
* NYHA class I, II, III (CCS I, II, III);
Exclusion Criteria:
* drugs intolerance or hypersensitivity;
* cardiogenic shock;ejection fraction (FE ) ≤ 50 % ;
* NYHA class IV (CCS IV);
* II or III atrioventricular block;
* a resting heart rate (HR) \< 50 bpm or sick sinus syndrome;
* rate-corrected QT interval (QTc) greater than 500 ms;
* age \<18 years;
* symptomatic hypotension or uncontrolled hypertension (systolic blood pressure at rest ≥ 180 mmHg or diastolic blood pressure ≥ 100 mmHg);
* severe liver disease
* severe renal impairment (creatinine clearance ≤ 30 ml/min);
* from moderate to severe electrolyte disorders (potassium concentration \< 2,5 or \> 6 mmol/L; calcium concentration \< 8 or \> 11 mg/dl; magnesium \< 1,8 or \> 2,5 mg/dl);
* pregnancy;
* concomitant administration of potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, voriconazole, posaconazole, HIV protease inhibitors, clarithromycin, telithromycin, nefazodone)
* concomitant administration of Class Ia (e.g. quinidine) or Class III (e.g. dofetilide, sotalol) antiarrhythmics other than amiodarone;
* previous cardiac interventions
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02687269
Study Brief:
Protocol Section:
NCT02687269