RACE 3 study: Intensive vs. usual rhythm control for atrial fibrillation.
- Conditions
- atrial fibrillationMedDRA version: 14.0Level: LLTClassification code 10003661Term: Atrial fibrillation paroxysmalSystem Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2009-011291-29-GB
- Lead Sponsor
- Interuniversity Cardiology Institute of the Netherlands (ICIN)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 250
- Early symptomatic persistent AF defined as: 1. total AF history < 2 years, and 2. total persistent AF duration > 7 days and < 6 months, and 3. = 1 previous ECV - Mild to moderate early HF, defined as: 1. Total HF history < 1 year, and 2. One of the following: ? LVEF = 45% and NYHA II-III, and normal pulmonary function and body mass •Previously documented HF-related NT-proBNP elevation (> 400 ng/l (=48 pmol/l)), or •Evidence of structural heart disease including LV hypertrophy (posterior wall and/or septum diameter = 11 mm or = 10 mm using Penn’s method as in MUMC) or regional LV dysfunction (akinesia, hypokinesia), or •Previous admission for HF, or •Evidence of diastolic dysfunction on echocardiography (average annular e’ <8 cm/s, ánd deceleration time > 220 ms, ánd average E/e’ > 8 or in case of color coded TDI E/e’ > 11) ? LVEF 25-45% and NYHA class I-III - Optimal documentation and treatment of underlying heart disease; - No contra-indication for oral anticoagulation; - Eligible for cardiovascular rehabilitation program; - Age = 40 years.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
- On waiting list for PVI or expected to be placed on waiting list for PVI within one year; - Symptoms not allowing ECV to be delayed for 3 weeks; - HF NYHA functional class IV; - LVEF < 25%. - Left atrial size > 50 mm (parasternal axis); - Severe valvular disease (previous valve repair/replacement is permitted); - Present ARA use; - Patients with cardiac resynchronization therapy; - Previous use of continuous prophylactic class I or class III antiarrhythmic drugs (except for sotalol, which should be discontinued at inclusion and replaced with beta-blocker); - Postoperative AF; - Myocardial infarction within last 3 months; - Hypersensitivity against ARAs; - Uncontrolled hypertension, defined as systolic blood pressure > 160 mmHg and/or a diastolic blood pressure > 95 mmHg (anti-hypertensive treatment is allowed); - Unstable angina pectoris; - Open heart surgery within the last 3 months; - Serum potassium > 5 mmol/l; - 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 euthyroidism; - Moderate to severe renal insufficiency (creatinine clearance less than 50 ml/min); - Patients with liver cirrhosis (Child-Pugh class C) or repeated ALT/AST 1.5 times the upper limit or other significant liver disease; - Co-administration of strong CYP3A4 inhibitors (i.e. grapefruit juice, ketoconazol, itraconazol, posaconazol, voriconazol, claritromycine, erytromycine, telitromycine, indinavir, nelfinavir, ritonavir, saquinavir, HIV-protease inhibitors) or strong CYP3A4 inductors (i.e. carbamazepine, rifampicine, St John’s wort [St Janskruid]); - Pregnancy; - Complex congenital heart diseases. The only congenital heart diseases that can be included are atrial septal defect, ventricular septal defect, bicuspid aortic stenosis; - Patients unlikely to comply with the protocol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method