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 @ 3:42 PM
Ignite Modification Date:
2025-12-24 @ 3:42 PM
NCT ID:
NCT00647192
Eligibility Criteria:
Inclusion Criteria:
* Persistent atrial fibrillation (AF), AF persistence for \> 7 days but \< 1 year
* Total AF history \< 2 years
* Written informed consent of the patient
* Age ≥18 years
* Female patients are sterilised or postmenopausal or apply an adequate method for contraception (Pearl index \<1%) and have a negative pregnancy test (ß-HCG) and do not breastfeed/nurse.
Exclusion Criteria:
* Hemodynamic instability or symptoms not allowing cardioversion to be delayed for 3 weeks
* Myocardial infarction within the last 3 months
* Heart failure NYHA class III - IV
* Uncontrolled hypertension, defined as a systolic blood pressure \> 160 mm Hg and/or a diastolic blood pressure \> 95 mm Hg (anti-hypertensive treatment is allowed).
* Pre-treatment with an aldosterone antagonist or other potassium sparing diuretics
* Instable angina pectoris
* Use of Digitalis
* Use of class I or class III antiarrhythmic drugs (must be stopped at least 5 half-life before)
* Contraindication or hypersensitivity to ß-blockers
* Open heart surgery within the last 3 months
* Pregnancy
* Acute and reversible illnesses
* Acute and chronic infection
* Alcohol or drug abuse or a severe progressive extracardiac disease
* Untreated manifest and latent hyper- or hypothyroidism or \< 3 months peripheral euthyroidism (normal fT3)
* Moderate to severe renal insufficiency (Creatinine clearance less than 50 ml/min)
* Patients with liver cirrhosis (Child-Pugh class C)
* Co-administration of strong CYP3A4 inhibitors (e.g. Itraconazole, Ketoconazole, Ritonavir, Nelfinavir, Clarithromycin, Telithromycin and Nephazodon)
* Hypersensitivity against Eplerenone and/or one of the other components of the tablet (see Fachinformation)
* Serum potassium \> 5 mmol/l
* Patients unlikely to comply with the protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00647192
Study Brief:
Protocol Section:
NCT00647192