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 @ 7:42 PM
Ignite Modification Date:
2025-12-24 @ 7:42 PM
NCT ID:
NCT00461903
Eligibility Criteria:
Inclusion Criteria:
* Patients must be age 18 years or older.
* Patients may be either male or female without childbearing potential (or with adequate contraception).
* Patients must have a current diagnosis of essential hypertension with systolic blood pressure (SBP) ≤ 160 mmHg and diastolic blood pressure (DBP) ≤ 100 mmHg at the time of inclusion visit AND
* Patients must have had at least one episode of symptomatic paroxysmal or persistent atrial fibrillation within the preceding six months:
* With an indication for cardioversion in the case of persistent AF
* With electrocardiogram (ECG) documentation of AF
* With duration of an AF episode of at least 10 minutes
Exclusion Criteria:
* Unlikely to co-operate in the study
* Pregnancy, breastfeeding, or possibility of becoming pregnant during the study (patients must have adequate contraception as determined by the investigator).
* Alcoholism or drug abuse
* Participation in another study at the same time or within 30 days of randomisation.
* Left ventricular systolic dysfunction with an ejection fraction of 45% or less
* Myocardial infarction within the past month prior to the selection visit
* Cardiac or thoracic surgery within the past 3 months or likely to be performed during the trial
* Chronic AF (continuously present for \> 6 months)
* AF secondary to an acute reversible condition (e.g. post-operative atrial fibrillation, hyperthyroidism)
* Currently requiring class I or class III anti-arrhythmic drug therapy (for atrial fibrillation or any other arrhythmia)
* Any medical condition that makes the patient an unsuitable candidate in the investigator's opinion
* Any medical condition requiring ACE inhibitor or angiotensin-receptor blocker therapy (e.g. diabetes, known proteinuria of more than 300 mg per day)
* Renal insufficiency with serum creatinine of 180 μmol/L or greater
* Known bilateral renal artery stenosis
* Serum potassium of 5.0 mmol/L or greater on recent laboratory exam
* Positive pregnancy test (beta human chorionic gonadotropin \[HCG\] performed in women of childbearing potential)
* Known intolerance to ACE inhibitor
* Impossibility to discontinue certain treatments at selection visit
* Known contraindication(s) to perindopril
* Severe known liver disease including cirrhosis, biliary obstruction or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevation more than 3 times the upper limit of normal
* Use of ACE inhibitor or angiotensin-receptor blocker in the 3 months before the inclusion visit
* Severely uncontrolled hypertension with SBP \> 160 mmHg or DBP \> 100 mmHg at the inclusion visit.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00461903
Study Brief:
Protocol Section:
NCT00461903