Permanent Atrial FibrillationPhase 4RATE-AFNCT02391337
Rate Control Therapy Evaluation in Permanent Atrial Fibrillation (RATE-AF)
A Phase 4 study testing Bisoprolol and Digoxin in people with Permanent Atrial Fibrillation, run by University of Birmingham at 2 sites in United Kingdom.
Trial summary
Atrial fibrillation is a common heart rhythm disturbance, causing important discomfort for patients, a high risk of stroke, frequent hospital admissions and a two-fold increase in death. The number of patients with this condition are expected to double in the next 20 years. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Permanent Atrial Fibrillation
- What is being tested?
- Bisoprolol and Digoxin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 20 Dec 2016to 16 Sep 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 60 years or older, able to provide informed written consent
- 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
Who cannot join
- Established indication for beta-blocker therapy, e.g. survived 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
- Known intolerance of beta-blockers or digoxin
- A history of severe bronchospasm (e.g. due to asthma) that would preclude use of beta-blockers
- Baseline heart rate <60 bpm
Show all 19Show fewer
- 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, 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 hypertrophic cardiomyopathy, myocarditis or constrictive pericarditis
- Received or on waiting list for heart transplantation
- Initiation of cardiac resynchronization therapy (with/without defibrillator) within 6 months prior to randomisation
- Intravenous infusions for heart failure (inotropes, vasodilators or diuretics) within 7 days prior to randomisation
- A current diagnosis of 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
City Hospital
Birmingham, West Midlands
Queen Elizabeth Hospital
Birmingham, West Midlands
About this study
Official title: Evaluating Different Rate Control Therapies in Permanent Atrial Fibrillation: A Prospective, Randomised, Open-label, Blinded Endpoint Feasibility Pilot Comparing Digoxin and Beta-blockers as Initial Rate Control Therapy
Atrial fibrillation is a common heart rhythm disturbance, causing important discomfort for patients, a high risk of stroke, frequent hospital admissions and a two-fold increase in death. The number of patients with this condition are expected to double in the next 20 years. Medications to control heart-rate are used in the majority of patients, although the choice of agent is often guided by local preference rather than evidence from controlled trials. Despite the fact that patients with atrial fibrillation have high rates of other cardiac conditions such as heart failure, clinicians have insufficient evidence to personalise the use of different therapies. This feasibility study will allow us to develop a range of methods that can characterise patients according to the pumping and relaxing function of the heart, the burden of symptoms and to identify new blood markers. In this way, the investigators hope to improve clinical practice guidelines, allowing doctors to prescribe appropriate treatments for the right patients.
The research will be focused around a randomised trial of two medication strategies, providing much-needed data on the comparison of digoxin and beta-blockers (two commonly-used drugs in patients with atrial fibrillation). It will also allow us to identify the best way to record patient-reported quality of life and develop robust techniques to determine heart function using non-invasive imaging, facilitating the conduct of a large-scale clinical trial. The key objectives of the research programme are to define the optimal medications for patients with atrial fibrillation and identify the most valid, reproducible and cost-effective methods to examine patients. The ultimate aim of the project is to improve clinical outcomes in atrial fibrillation, benefiting patients, the National Health Service and the global community.
Read the detailed description
Atrial fibrillation (AF) is an increasingly common cardiac condition that leads to a substantial burden on quality-of-life (QoL), an increased risk of cardiovascular events, hospitalisation and death, and significant healthcare costs for the NHS. In addition to anti-coagulation and considerations for rhythm control therapy, most patients with AF are in need of pharmacological control of heart rate. This aspect of care has not received stringent investigation, with treatment guidelines based on small crossover studies and observational data rather than robust controlled trials. Beta-blocker monotherapy remains the first-line option in the current NICE AF guidelines consultation document, with digoxin only for sedentary patients, although this recommendation is based on 'very low-quality evidence'. The benefit of different rate-control therapies on symptoms and other intermediate outcomes (such as left-ventricular ejection fraction [LVEF] and diastolic function) are unknown, as are their effects on clinical events such as hospitalisation. This situation is unacceptable in light of the potential benefits and risk of different rate-control options in AF. It also limits our ability to personalise treatment according to patient characteristics.
The RAte control Therapy Evaluation in permanent Atrial Fibrillation (RATE-AF) trial is informed by a number of in-depth systematic reviews of management and clinical outcomes in AF patients. Taken together, this information provides a sound basis to plan a major randomised controlled trial (RCT). However as trials of rate-control in AF have typically been small or uncontrolled, further information is needed before designing a trial that can assess clinical outcomes. The RATE-AF trial will allow us to define appropriate primary and secondary outcome measures and their standard deviation in a contemporary population of patients with permanent AF. This information will allow us to estimate sample size, determination of recruitment, retention and adherence policies, and to ascertain the best methods of obtaining adverse event data and reliable economic costs for a larger trial assessing cardiovascular outcomes and hospitalization. The RATE-AF trial will also be the largest RCT of its kind, allowing us to compare the effect of beta-blockers and digoxin on QoL as initial rate-control therapy in patients with permanent AF. The long-term aim of the research is to answer key questions about how to initiate therapy, stratified by relevant patient characteristics such as systolic and diastolic cardiac function, baseline symptoms and concurrent medication. The research will also define the patho-physiological mechanisms underlying AF-related symptoms, left-ventricular function and their association with adverse clinical outcomes, and to identify clinical markers for the response to different rate control therapy.
- Conditions
- Permanent Atrial Fibrillation
- Being tested
- Bisoprolol, Digoxin
- Keywords
- Atrial fibrillation, Quality of life, Left ventricular ejection fraction, Diastolic function, Echocardiography, Beta-blockers, Digoxin
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BisoprololDrug
Drug intervention
DigoxinDrug
Drug intervention
| Study group | Role | What they receive |
|---|---|---|
| Beta-blocker | Active comparator | In Group B, oral bisoprolol will be commenced at either 1.25mg, 2.5mg or 5mg according to the treatment schedule and uptitrated, as required, to 15mg daily. Recommended additional therapy in this arm includes diltiazem. Use of digoxin is explicitly discouraged but will not terminate participation in the study. If intolerance to bisoprolol occurs, investigators will be advised to try an alternate beta-blocker of their choosing (typically carvedilol, nebivolol, or metoprolol) at equivalent dosage. Receives: Drug: Bisoprolol |
| Digoxin | Active comparator | In Group A, the maintenance dose of oral digoxin will be either 62.5mcg or 125mcg according to the pre-defined treatment schedule and uptitrated, as required, to 250mcg daily. A single loading dose of four tablets (250 or 500mcg according to target maintenance dose) will be prescribed in digoxin-naïve participants, where necessary. Recommended additional therapy in this arm includes the calcium-channel blocker diltiazem. Use of beta-blockers is explicitly discouraged but will not terminate participation in the study. Receives: Drug: Digoxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Reported Quality of Life (SF-36)
Patient-reported outcomes as assessed by the SF-36 questionnaire physical component score.
The physical component score ranges from 0-100 where higher value indicates better outcome.
Measured: Primary outcome at 6 months timepoint.
Secondary outcomes (8)
Left Ventricular Ejection Fraction
The above parameters will be measured using echocardiography and diastolic indices
Measured: 12 months
Diastolic Function- Measured by the E/e'.
The above parameters will be measured using echocardiography and diastolic indices.
E/e' - the ratio between early mitral inflow velocity and mitral annular early diastolic velocity.
Measured: 12 months
B-type Natriuretic Peptide (BNP) at 6 Months.
B-type natriuretic peptide (BNP) at 6 months.
Measured: 6 months
Composite Functional Status Measures- 6 Minute Walking Distance at 12 Months.
Composite functional status measures- 6 minute walking distance at 12 months.
Measured: 12 months
Patient Reported Outcomes- (AFEQT) at 12 Months.
As assessed using the AFEQT overall score at 12 months. The range for AFEQT overall score is from 0= complete disability to 100=no disability.
Measured: 12 months
Patient Reported Outcomes (SF36) Version 2 at 12 Months.
As assessed using the SF-36 version 2 global and specific scores at 12 months. All domains presented are between 0 to 100 scale where the higher score indicates better outcomes.
Measured: 12 months
Patient Reported Outcomes (EQ-5D-5L)
As assessed using the EQ-5D-5L summary index questionnaires at both 6 and 12 months.
The range for summary index is from -0.594=worst score to 1=best score
Measured: 12 months
Ambulatory Heart-rate.
24 hour ambulatory heart-rate.
Measured: Within 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study start20 Dec 2016
- Primary completion15 Apr 2019
- Study completion16 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Permanent Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dipak Kotecha, MBChB PhD MRCP, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02391337
- Sponsor's protocol ID
- UBCCS_RATEAF
- Acronym
- RATE-AF
- Status last verified
- Jun 2021
- First submitted
- 27 Feb 2015
- Last updated
- 18 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kotecha D, Holmes J, Krum H, Altman DG, Manzano L, Cleland JG, Lip GY, Coats AJ, Andersson B, Kirchhof P, von Lueder TG, Wedel H, Rosano G, Shibata MC, Rigby A, Flather MD; Beta-Blockers in Heart Failure Collaborative Group. Efficacy of beta blockers in patients with heart failure plus atrial fibrillation: an individual-patient data meta-analysis. Lancet. 2014 Dec 20;384(9961):2235-43. doi: 10.1016/S0140-6736(14)61373-8. Epub 2014 Sep 2.
PubMed 25193873Akoumianakis I, Gilligan LC, Bunting KV, Fobian D, Kirchhof P, Arlt W, Taylor AE, Pavlovic D, Kotecha D; Rate control Therapy Evaluation in permanent Atrial Fibrillation (RATE-AF) trial team. Quantification and impact of circulating cardiotonic steroids in the RATE-AF randomised trial of patients with atrial fibrillation and heart failure. BMC Med. 2025 Dec 29;23(1):694. doi: 10.1186/s12916-025-04476-2.
PubMed 41462450Abdali Z, Bunting KV, Mehta S, Camm J, Rahimi K, Stanbury M, Haynes S, Kotecha D, Jowett S. Cost-effectiveness of digoxin versus beta blockers in permanent atrial fibrillation: the Rate Control Therapy Evaluation in Permanent Atrial Fibrillation (RATE-AF) randomised trial. Heart. 2025 Mar 26;111(8):362-369. doi: 10.1136/heartjnl-2024-324761.
PubMed 39819610Gill SK, Barsky A, Guan X, Bunting KV, Karwath A, Tica O, Stanbury M, Haynes S, Folarin A, Dobson R, Kurps J, Asselbergs FW, Grobbee DE, Camm AJ, Eijkemans MJC, Gkoutos GV, Kotecha D; BigData@Heart Consortium; cardAIc group; RATE-AF trial team. Consumer wearable devices for evaluation of heart rate control using digoxin versus beta-blockers: the RATE-AF randomized trial. Nat Med. 2024 Jul;30(7):2030-2036. doi: 10.1038/s41591-024-03094-4. Epub 2024 Jul 15.
PubMed 39009776Kotecha D, Bunting KV, Gill SK, Mehta S, Stanbury M, Jones JC, Haynes S, Calvert MJ, Deeks JJ, Steeds RP, Strauss VY, Rahimi K, Camm AJ, Griffith M, Lip GYH, Townend JN, Kirchhof P; Rate Control Therapy Evaluation in Permanent Atrial Fibrillation (RATE-AF) Team. Effect of Digoxin vs Bisoprolol for Heart Rate Control in Atrial Fibrillation on Patient-Reported Quality of Life: The RATE-AF Randomized Clinical Trial. JAMA. 2020 Dec 22;324(24):2497-2508. doi: 10.1001/jama.2020.23138.
PubMed 33351042Kotecha D, Calvert M, Deeks JJ, Griffith M, Kirchhof P, Lip GY, Mehta S, Slinn G, Stanbury M, Steeds RP, Townend JN. A review of rate control in atrial fibrillation, and the rationale and protocol for the RATE-AF trial. BMJ Open. 2017 Jul 20;7(7):e015099. doi: 10.1136/bmjopen-2016-015099.
PubMed 28729311
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Different Rate Control Therapies in Permanent Atrial Fibrillation: A Prospective, Randomised, Open-label, Blinded Endpoint Feasibility Pilot Comparing Digoxin and Beta-blockers as Initial Rate Control Therapy
- ClinicalTrials.gov ID
- NCT02391337
- Acronym / sponsor ID
- RATE-AF / UBCCS_RATEAF
- Conditions
- Permanent Atrial Fibrillation
- Keywords
- Atrial fibrillation, Quality of life, Left ventricular ejection fraction, Diastolic function, Echocardiography, Beta-blockers, Digoxin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Study start
- 20 Dec 2016 (actual)
- Primary completion
- 15 Apr 2019 (actual)
- Study completion
- 16 Sep 2019 (actual)
- First posted
- 18 Mar 2015 (estimated)
- Results
- Posted 16 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Atrial fibrillation is a common heart rhythm disturbance, causing important discomfort for patients, a high risk of stroke, frequent hospital admissions and a two-fold increase in death. The number of patients with this condition are expected to double in the next 20 years. Medications to control heart-rate are used in the majority of patients, although the choice of agent is often guided by local preference rather than evidence from controlled trials. Despite the fact that patients with atrial fibrillation have high rates of other cardiac conditions such as heart failure, clinicians have insufficient evidence to personalise the use of different therapies. This feasibility study will allow us to develop a range of methods that can characterise patients according to the pumping and relaxing function of the heart, the burden of symptoms and to identify new blood markers. In this way, the investigators hope to improve clinical practice guidelines, allowing doctors to prescribe appropriate treatments for the right patients.
The research will be focused around a randomised trial of two medication strategies, providing much-needed data on the comparison of digoxin and beta-blockers (two commonly-used drugs in patients with atrial fibrillation). It will also allow us to identify the best way to record patient-reported quality of life and develop robust techniques to determine heart function using non-invasive imaging, facilitating the conduct of a large-scale clinical trial. The key objectives of the research programme are to define the optimal medications for patients with atrial fibrillation and identify the most valid, reproducible and cost-effective methods to examine patients. The ultimate aim of the project is to improve clinical outcomes in atrial fibrillation, benefiting patients, the National Health Service and the global community.
Detailed description
Atrial fibrillation (AF) is an increasingly common cardiac condition that leads to a substantial burden on quality-of-life (QoL), an increased risk of cardiovascular events, hospitalisation and death, and significant healthcare costs for the NHS. In addition to anti-coagulation and considerations for rhythm control therapy, most patients with AF are in need of pharmacological control of heart rate. This aspect of care has not received stringent investigation, with treatment guidelines based on small crossover studies and observational data rather than robust controlled trials. Beta-blocker monotherapy remains the first-line option in the current NICE AF guidelines consultation document, with digoxin only for sedentary patients, although this recommendation is based on 'very low-quality evidence'. The benefit of different rate-control therapies on symptoms and other intermediate outcomes (such as left-ventricular ejection fraction [LVEF] and diastolic function) are unknown, as are their effects on clinical events such as hospitalisation. This situation is unacceptable in light of the potential benefits and risk of different rate-control options in AF. It also limits our ability to personalise treatment according to patient characteristics.
The RAte control Therapy Evaluation in permanent Atrial Fibrillation (RATE-AF) trial is informed by a number of in-depth systematic reviews of management and clinical outcomes in AF patients. Taken together, this information provides a sound basis to plan a major randomised controlled trial (RCT). However as trials of rate-control in AF have typically been small or uncontrolled, further information is needed before designing a trial that can assess clinical outcomes. The RATE-AF trial will allow us to define appropriate primary and secondary outcome measures and their standard deviation in a contemporary population of patients with permanent AF. This information will allow us to estimate sample size, determination of recruitment, retention and adherence policies, and to ascertain the best methods of obtaining adverse event data and reliable economic costs for a larger trial assessing cardiovascular outcomes and hospitalization. The RATE-AF trial will also be the largest RCT of its kind, allowing us to compare the effect of beta-blockers and digoxin on QoL as initial rate-control therapy in patients with permanent AF. The long-term aim of the research is to answer key questions about how to initiate therapy, stratified by relevant patient characteristics such as systolic and diastolic cardiac function, baseline symptoms and concurrent medication. The research will also define the patho-physiological mechanisms underlying AF-related symptoms, left-ventricular function and their association with adverse clinical outcomes, and to identify clinical markers for the response to different rate control therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beta-blocker | Active comparator | Drug: BisoprololIn Group B, oral bisoprolol will be commenced at either 1.25mg, 2.5mg or 5mg according to the treatment schedule and uptitrated, as required, to 15mg daily. Recommended additional therapy in this arm includes diltiazem. Use of digoxin is explicitly discouraged but will not terminate participation in the study. If intolerance to bisoprolol occurs, investigators will be advised to try an alternate beta-blocker of their choosing (typically carvedilol, nebivolol, or metoprolol) at equivalent dosage. |
| Digoxin | Active comparator | Drug: DigoxinIn Group A, the maintenance dose of oral digoxin will be either 62.5mcg or 125mcg according to the pre-defined treatment schedule and uptitrated, as required, to 250mcg daily. A single loading dose of four tablets (250 or 500mcg according to target maintenance dose) will be prescribed in digoxin-naïve participants, where necessary. Recommended additional therapy in this arm includes the calcium-channel blocker diltiazem. Use of beta-blockers is explicitly discouraged but will not terminate participation in the study. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients aged 60 years or older, able to provide informed written consent
- 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
Key exclusion criteria (19 listed)
- Established indication for beta-blocker therapy, e.g. survived 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
- Known intolerance of beta-blockers or digoxin
- A history of severe bronchospasm (e.g. due to asthma) that would preclude use of beta-blockers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BisoprololDrug intervention | Drug | Beta-blocker |
| DigoxinDrug intervention | Drug | Digoxin |
Primary outcome
Patient Reported Quality of Life (SF-36)
Time frame: Primary outcome at 6 months timepoint.
Patient-reported outcomes as assessed by the SF-36 questionnaire physical component score. The physical component score ranges from 0-100 where higher value indicates better outcome.
8 secondary outcomes
Left Ventricular Ejection Fraction
Time frame: 12 months
Diastolic Function- Measured by the E/e'.
Time frame: 12 months
B-type Natriuretic Peptide (BNP) at 6 Months.
Time frame: 6 months
Composite Functional Status Measures- 6 Minute Walking Distance at 12 Months.
Time frame: 12 months
Patient Reported Outcomes- (AFEQT) at 12 Months.
Time frame: 12 months
Patient Reported Outcomes (SF36) Version 2 at 12 Months.
Time frame: 12 months
Patient Reported Outcomes (EQ-5D-5L)
Time frame: 12 months
Ambulatory Heart-rate.
Time frame: Within 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25193873Kotecha D, Holmes J, Krum H, Altman DG, Manzano L, Cleland JG, Lip GY, Coats AJ, Andersson B, Kirchhof P, von Lueder TG, Wedel H, Rosano G, Shibata MC, Rigby A, Flather MD; Beta-Blockers in Heart Failure Collaborative Group. Efficacy of beta blockers in patients with heart failure plus atrial fibrillation: an individual-patient data meta-analysis. Lancet. 2014 Dec 20;384(9961):2235-43. doi: 10.1016/S0140-6736(14)61373-8. Epub 2014 Sep 2.
- Derived from this study: PubMed 41462450Akoumianakis I, Gilligan LC, Bunting KV, Fobian D, Kirchhof P, Arlt W, Taylor AE, Pavlovic D, Kotecha D; Rate control Therapy Evaluation in permanent Atrial Fibrillation (RATE-AF) trial team. Quantification and impact of circulating cardiotonic steroids in the RATE-AF randomised trial of patients with atrial fibrillation and heart failure. BMC Med. 2025 Dec 29;23(1):694. doi: 10.1186/s12916-025-04476-2.
- Derived from this study: PubMed 39819610Abdali Z, Bunting KV, Mehta S, Camm J, Rahimi K, Stanbury M, Haynes S, Kotecha D, Jowett S. Cost-effectiveness of digoxin versus beta blockers in permanent atrial fibrillation: the Rate Control Therapy Evaluation in Permanent Atrial Fibrillation (RATE-AF) randomised trial. Heart. 2025 Mar 26;111(8):362-369. doi: 10.1136/heartjnl-2024-324761.
- Derived from this study: PubMed 39009776Gill SK, Barsky A, Guan X, Bunting KV, Karwath A, Tica O, Stanbury M, Haynes S, Folarin A, Dobson R, Kurps J, Asselbergs FW, Grobbee DE, Camm AJ, Eijkemans MJC, Gkoutos GV, Kotecha D; BigData@Heart Consortium; cardAIc group; RATE-AF trial team. Consumer wearable devices for evaluation of heart rate control using digoxin versus beta-blockers: the RATE-AF randomized trial. Nat Med. 2024 Jul;30(7):2030-2036. doi: 10.1038/s41591-024-03094-4. Epub 2024 Jul 15.
- Derived from this study: PubMed 33351042Kotecha D, Bunting KV, Gill SK, Mehta S, Stanbury M, Jones JC, Haynes S, Calvert MJ, Deeks JJ, Steeds RP, Strauss VY, Rahimi K, Camm AJ, Griffith M, Lip GYH, Townend JN, Kirchhof P; Rate Control Therapy Evaluation in Permanent Atrial Fibrillation (RATE-AF) Team. Effect of Digoxin vs Bisoprolol for Heart Rate Control in Atrial Fibrillation on Patient-Reported Quality of Life: The RATE-AF Randomized Clinical Trial. JAMA. 2020 Dec 22;324(24):2497-2508. doi: 10.1001/jama.2020.23138.
- Derived from this study: PubMed 28729311Kotecha D, Calvert M, Deeks JJ, Griffith M, Kirchhof P, Lip GY, Mehta S, Slinn G, Stanbury M, Steeds RP, Townend JN. A review of rate control in atrial fibrillation, and the rationale and protocol for the RATE-AF trial. BMJ Open. 2017 Jul 20;7(7):e015099. doi: 10.1136/bmjopen-2016-015099.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dipak Kotecha, MBChB PhD MRCP principal investigator
University of Birmingham
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bisoprolol and Digoxin in people with Permanent Atrial Fibrillation, run by University of Birmingham at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Reported Quality of Life (SF-36) (time frame: Primary outcome at 6 months timepoint.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02391337, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.