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 @ 6:47 PM
Ignite Modification Date:
2025-12-24 @ 6:47 PM
NCT ID:
NCT03178357
Eligibility Criteria:
Inclusion Criteria:
1. Patient with hypertrophic cardiomyopathy (defined in accordance with the ESC guidelines for the diagnosis and management of cardiomyopathy and hypertrophy in 2014): thickness ≥ 15 mm of one or more segments of the left ventricular wall measured using any imaging technique \[echocardiography, cardiac magnetic resonance or computed tomography\] which can not be explained solely by the left ventricular loading conditions) without left ventricular outflow tract obstruction at rest: gradient \<30 mmHg.
2. Stable general condition (1 month period).
3. NYHA Class II and III.
4. Preserved LV systolic function (LVEF ≥ 50%).
5. Condition after ICD implantation.
6. Written informed consent of the patient to participate in the Program.
7. Completed eighteen years of age.
Exclusion Criteria:
1. Complex life-threatening ventricular arrhythmias that can not be treated.
2. Uncontrolled hypertension.
3. Advanced atrio-ventricular block.
4. Myocarditis or pericarditis (up to 6 months).
5. Symptomatic aortic stenosis.
6. Acute systemic illness.
7. Intracardiac thrombosis.
8. Significant ischaemia during low intensity exercise test (2 METS, 50W).
9. Uncontrolled diabetes.
10. Pulmonary embolism (up to 6 months).
11. Thrombophlebitis.
12. New episode of AF/Afl.
13. Decrease in systolic blood pressure during exercise.
14. Co-morbidities that limit exercise tolerance and prevent exercise.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03178357
Study Brief:
Protocol Section:
NCT03178357