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 @ 7:41 PM
Ignite Modification Date:
2025-12-24 @ 7:41 PM
NCT ID:
NCT01223703
Eligibility Criteria:
Inclusion Criteria:
* patients with a diagnosis of non ischemic cardiomyopathy (the absence of coronary artery disease,defined as the absence of stenosis \> 50%, was confirmed by angiography performed at the time of the diagnostic workup of the cardiomyopathy)
* LV systolic dysfunction (defined as an EF \< 45%)
* Stable clinical conditions with minimal or no symptoms for at least three month
* Evidence-based medical treatment at maximum tolerated target doses for at least six month
Exclusion Criteria:
* presence of symptoms or evidence of CAD diagnosed through noninvasive tests;
* peripheral arterial disease;
* presence of congenital or primary valvular heart disease;
* persistent atrial fibrillation;
* inability to perform bicycle ergometry for noncardiac causes;
* moderately to severely reduced functional capacity;
* NYHA functional class IV;
* poor acoustic windows limiting the ability to assess echocardiographic measurements;
* chronic lung disease;
* advanced renal disease (eGFR \< 30 mL/min/1.73 m2);
* advanced liver disease;
* any disease limiting life expectancy to one year or less;
* contraindications to study drugs;
* concomitant participation in other research studies
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01223703
Study Brief:
Protocol Section:
NCT01223703