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:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-26 @ 11:00 AM
NCT ID:
NCT03536806
Eligibility Criteria:
Inclusion Criteria:
* written informed consent for enrolment
* patients aged between 40 and 75 years
* atrial fibrillation episode lasting for less than 48 hours, documented by the ECG
* potassium plasma levels \< 4.5 mmol/l
* blood pressure \> 120/80 mmHg
* stable cardiopulmonary status (according to attending physician's assessment)
* in case of left ventricle injury suspicion or unclear medical history of cardiac insufficiency, enrolment will be possible after echocardiographic examination
Exclusion Criteria:
* no written informed consent for enrollment
* allergy to canrenone
* cardiac insufficiency or LVEF (left ventricular ejection fraction) \< 40%
* systolic BP \< 120/80 mmHg
* history of canrenone treatment in the 30 days before enrollment
* average QRS rate \> 160 p.m.
* advanced hepatic or renal failure
* history of acute coronary syndrome, CABG (coronary artery bypass grafting), TIA (transient ischemic attack) or stroke within the previous 30 days
* pre-excitation syndrome (which has not been treated with accessory pathway ablation).
* atrial fibrillation due to a valvular heart disease
* atrial fibrillation episode resulting in myocardial ischemia (chest pain, ischemic changes in the ECG)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT03536806
Study Brief:
Protocol Section:
NCT03536806