Rate control therapy evaluation in atrial fibrillatio

Phase 4

Completed

• Conditions: Specialty: Cardiovascular disease, Primary sub-specialty: Other; UKCRC code/ Disease: Cardiovascular/ Other forms of heart disease; Circulatory System; Atrial fibrillation

• Registration Number: ISRCTN95259705
• Lead Sponsor: niversity of Birmingham

Brief Summary

2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/28729311 2020 results in https://doi.org/10.1001/jama.2020.23138 (added 25/01/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-29
• Study Completion: 2019-12-31
• Last Update Posted: 8 February 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. Adult patients aged 60 years or older
2. 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
3. Symptoms of breathlessness (New York Heart Association Class II or more)
4. Able to provide written informed consent

Exclusion Criteria

Current exclusion criteria as of 22/06/2018:
1. Established clinical indication for beta-blocker therapy, e.g. myocardial infarction in the last 6 months
2. 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
3. Baseline heart rate history of atrioventricular node ablation
4. History of second or third-degree heart block
5. Supraventricular arrhythmias associated with accessory conducting pathways (e.g. Wolff-Parkinson-White syndrome) or a history of ventricular tachycardia or fibrillation
6. Decompensated heart failure (evidenced by need for intravenous inotropes, vasodilators or diuretics) within 14 days prior to randomisation
7. A current diagnosis of obstructive hypertrophic cardiomyopathy, myocarditis or constrictive pericarditis
8. Received or on waiting list for heart transplantation
9. Receiving renal replacement therapy
10. Major surgery, including thoracic or cardiac surgery, within 3 months of randomisation
11. Severe, concomitant non-cardiovascular disease (including malignancy) that is expected to reduce life expectancy

Previous exclusion criteria:
1. Established clinical indication for beta-blocker therapy, e.g. myocardial infarction in the last 6 months
2. 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
3. Baseline heart rate history of atrioventricular node ablation
4. Decompensated heart failure (evidenced by need for intravenous inotropes, vasodilators or diuretics) within 14 days prior to randomisation
5. A current diagnosis of obstructive hypertrophic cardiomyopathy, myocarditis or constrictive pericarditis
6. Received or on waiting list for heart transplantation
7. Receiving renal replacement therapy
8. Major surgery, including thoracic or cardiac surgery, within 3 months of randomisation
9. Severe, concomitant non-cardiovascular disease (including malignancy) that is expected to reduce life expectancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified