RAte control Therapy Evaluation in permanent Atrial Fibrillation: RATE-AF

Phase 1

• Conditions: Atrial fibrillation; MedDRA version: 19.0Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-005043-13-GB
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-09
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

•Adult patients aged 60 years or older
•Permanent AF, characterised (at time of randomisation) as a physician decision for rate-control with no plans for cardioversion, anti-arrhythmic medication, or ablation therapy
•Symptoms of breathlessness (New York Heart Association Class II or more)
•Able to provide written informed consent

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 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 145

Exclusion Criteria

•Established clinical indication for beta-blocker therapy, e.g. myocardial infarction in the last 6 months
•Known contraindications for therapy with beta-blockers or digoxin, e.g. a history of severe bronchospasm that would preclude use of beta-blockers, or known intolerance to these medications
•Baseline heart rate <60 bpm
•History of second or third-degree heart block
•Supraventricular arrhythmias associated with accessory conducting pathways (e.g. Wolff-Parkinson-White syndrome) or a history of ventricular tachycardia or fibrillation
•Planned pacemaker implantation (including cardiac resynchronisation therapy), pacemaker-dependent rhythm or history of atrioventricular node ablation
•Decompensated heart failure (evidenced by need for intravenous inotropes, vasodilators or diuretics) within 14 days prior to randomisation
•A current diagnosis of obstructive hypertrophic cardiomyopathy, myocarditis or constrictive pericarditis
•Received or on waiting list for heart transplantation
•Receiving renal replacement therapy
•Major surgery, including thoracic or cardiac surgery, within 3 months of randomisation
•Severe, concomitant non-cardiovascular disease (including malignancy) that is expected to reduce life expectancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified