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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bisoprolol | Drug | Drug intervention |
| |
| Digoxin |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Primary outcome at 6 months timepoint. |
| Measure | Description | Time Frame |
|---|---|---|
| Left Ventricular Ejection Fraction | The above parameters will be measured using echocardiography and diastolic indices | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular Events | Number of Participants with hospital admissions for cardiovascular events. | 12 months |
| Drug Discontinuation Rate | the number and extent to which patients discontinue trial drugs |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dipak Kotecha, MBChB PhD MRCP | University of Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City Hospital | Birmingham | West Midlands | United Kingdom | |||
| Queen Elizabeth Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25193873 | Background | 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. | |
| 41462450 |
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A total of 390 were screened for the trial, of these screened 161 were randomised.
The trial opened for recruitment in December 2016 and the first participant was randomised on the 20th December 2016 and the last participant was randomised on the 1st October 2018. A total of 161 participants were randomised into the trial with 1 centre recruiting patients into the trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | Beta-blocker | 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. Bisoprolol: Drug intervention |
| FG001 | Digoxin | 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. Digoxin: Drug intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
| |||||||||||||
| 6 Months Follow-up |
| |||||||||||||
| 12 Months Follow-up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Beta-blocker | 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. Bisoprolol: Drug intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | ITT Analysis | Posted | Mean | Standard Deviation | score on a scale | Primary outcome at 6 months timepoint. |
|
During the 12 month follow-up period.
Adverse events (AEs) were recorded in the medical records and CRFs. Most AE/ARs that occurred in the trial, whether they are serious or not, were 'expected' treatment-related toxicities due to the drugs used in this trial.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Beta-blocker | 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. Bisoprolol: Drug intervention |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Arrhythmia | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal upset | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dipak Kotecha | University of Birmingham | +44 (0) 7974 115676 | d.kotecha@bham.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 25, 2019 | Mar 29, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 17, 2019 | Apr 29, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D017298 | Bisoprolol |
| D004077 | Digoxin |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| Drug |
Drug intervention |
|
| 12 months |
| B-type Natriuretic Peptide (BNP) at 6 Months. | B-type natriuretic peptide (BNP) at 6 months. | 6 months |
| Composite Functional Status Measures- 6 Minute Walking Distance at 12 Months. | Composite functional status measures- 6 minute walking distance at 12 months. | 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. | 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. | 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 | 12 months |
| Ambulatory Heart-rate. | 24 hour ambulatory heart-rate. | Within 12 months |
| 12 months |
| Drug Discontinuation Rate Within 12 Months. | Number of participants requiring drug discontinuation due to adverse reactions. | 12 months |
| Hospital Admission Rate | A composite of adverse clinical events | 12 months |
| Retention of Participants | Convenience, compliance and cross-over data | 12 months |
| Preferred Outcome Measures for This Cohort of Patients | Establish which are the best measures for these patients | 12 months |
| Population-specific Standard Deviations to Enable Sample Size Calculation for a Future Trial Powered to Detect a Difference in Hospital Admissions. | SF-36 physical function score at 6 and 12 months | 12 months |
| Population-specific Standard Deviations to Enable Sample Size Calculation for a Future Trial Powered to Detect a Difference in Hospital Admissions. | SF-36 overall score at 6 and 12 months | 12 months |
| Population-specific Standard Deviations to Enable Sample Size Calculation for a Future Trial Powered to Detect a Difference in Hospital Admissions. | AFEQT overall score at 6 and 12 months | 12 months |
| Population-specific Standard Deviations to Enable Sample Size Calculation for a Future Trial Powered to Detect a Difference in Hospital Admissions. | LVEF and E/e scores at 6 and 12 months | 12 months |
| Number of Participants With Unplanned Hospital Admissions. | Number of Participants with Unplanned Hospital Admissions. | During the 12 month follow-up period. |
| Birmingham |
| West Midlands |
| United Kingdom |
| Derived |
| Akoumianakis 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. |
| 39819610 | Derived | Abdali 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. |
| 39009776 | Derived | Gill 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. |
| 33351042 | Derived | Kotecha 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. |
| 28729311 | Derived | Kotecha 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. |
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
|
| BG001 | Digoxin | 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. Digoxin: Drug intervention |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Creatinine | Mean | Standard Deviation | Micromol/l |
|
| On anticoagulant before randomisation | Count of Participants | Participants |
|
| EHRA class | Minimisation variables Note: EHRA Class was categorised into (Class 1, 2a) and (Class 2b, 3, 4) for the minimisation algorithm. The European Heart Rhythm Association score of atrial fibrillation (or EHRA score) is a classification system for the extent of atrial fibrillation. EHRA I - 'No symptoms' EHRA II - 'Mild symptoms'; normal daily activity not affected EHRA III - 'Severe symptoms'; normal daily activity affected EHRA IV - 'Disabling symptoms'; normal daily activity discontinued | Count of Participants | Participants |
|
| NYHA class | NYHA Classification - The Stages of Heart Failure: Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).Comfortable only at rest. Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients. | Count of Participants | Participants |
|
| Previous diagnosis of heart failure? | Count of Participants | Participants |
|
| Any signs of heart failure at baseline | Count of Participants | Participants |
|
| Type I diabetes | Count of Participants | Participants |
|
| Type II diabetes | Count of Participants | Participants |
|
| Unplanned admission for AF or HF in last 12 months | Count of Participants | Participants |
|
| Any previous cardioversions | Count of Participants | Participants |
|
| Previously undergone AF ablation | Count of Participants | Participants |
|
| Previous history of anti-arrhythmic drugs | Count of Participants | Participants |
|
| Baseline NTproBNP | Median | Inter-Quartile Range | pg/mL |
|
| Radial artery heart rate | Mean | Standard Deviation | bpm |
|
| Apex beat heart rate | Mean | Standard Deviation | bpm |
|
| 12-Lead ECG Heart Rate | Mean | Standard Deviation | bpm |
|
| Systolic BP | Mean | Standard Deviation | mmHg |
|
| Estimated ejection fraction | Mean | Standard Deviation | Percentage of ejection fraction |
|
| OG001 | Digoxin | 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. Digoxin: Drug intervention |
|
|
| Secondary | Left Ventricular Ejection Fraction | The above parameters will be measured using echocardiography and diastolic indices | Posted | Mean | Standard Deviation | percentage of ejection fraction | 12 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Ratio of E/e' | 12 months |
|
|
|
| Secondary | B-type Natriuretic Peptide (BNP) at 6 Months. | B-type natriuretic peptide (BNP) at 6 months. | Posted | Median | Inter-Quartile Range | ng/L | 6 months |
|
|
|
| Secondary | Composite Functional Status Measures- 6 Minute Walking Distance at 12 Months. | Composite functional status measures- 6 minute walking distance at 12 months. | Posted | Median | Inter-Quartile Range | metres | 12 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
| Secondary | 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. | Some domains of the SFF36 version 2 were not possible to be computed due to missing data in the questionnaire. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
| Secondary | Ambulatory Heart-rate. | 24 hour ambulatory heart-rate. | Posted | Mean | Standard Deviation | bpm | Within 12 months |
|
|
|
| Other Pre-specified | Cardiovascular Events | Number of Participants with hospital admissions for cardiovascular events. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Other Pre-specified | Drug Discontinuation Rate | the number and extent to which patients discontinue trial drugs | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Other Pre-specified | Drug Discontinuation Rate Within 12 Months. | Number of participants requiring drug discontinuation due to adverse reactions. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Other Pre-specified | Hospital Admission Rate | A composite of adverse clinical events | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Other Pre-specified | Retention of Participants | Convenience, compliance and cross-over data | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Other Pre-specified | Preferred Outcome Measures for This Cohort of Patients | Establish which are the best measures for these patients | Not Posted | 12 months | Participants |
| Other Pre-specified | Population-specific Standard Deviations to Enable Sample Size Calculation for a Future Trial Powered to Detect a Difference in Hospital Admissions. | SF-36 physical function score at 6 and 12 months | Not Posted | 12 months | Participants |
| Other Pre-specified | Population-specific Standard Deviations to Enable Sample Size Calculation for a Future Trial Powered to Detect a Difference in Hospital Admissions. | SF-36 overall score at 6 and 12 months | Not Posted | 12 months | Participants |
| Other Pre-specified | Population-specific Standard Deviations to Enable Sample Size Calculation for a Future Trial Powered to Detect a Difference in Hospital Admissions. | AFEQT overall score at 6 and 12 months | Not Posted | 12 months | Participants |
| Other Pre-specified | Population-specific Standard Deviations to Enable Sample Size Calculation for a Future Trial Powered to Detect a Difference in Hospital Admissions. | LVEF and E/e scores at 6 and 12 months | Not Posted | 12 months | Participants |
| Other Pre-specified | Number of Participants With Unplanned Hospital Admissions. | Number of Participants with Unplanned Hospital Admissions. | Posted | Count of Participants | Participants | During the 12 month follow-up period. |
|
|
|
| 7 |
| 80 |
| 21 |
| 80 |
| 51 |
| 80 |
| EG001 | Digoxin | 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. Digoxin: Drug intervention | 4 | 81 | 13 | 81 | 20 | 81 |
| Cardiac General | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Haemorrhage/Bleeding | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Gastrointestinal | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pulmonary/Upper Respiratory | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Constitutional Symptoms | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dermatology/Skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pain | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Musculoskeletal/Soft Tissue | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hepatobiliary/Pancreas | Hepatobiliary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Neurology | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Secondary Malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Non-systematic Assessment |
|
| Renal/Genitourinary | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Vascular | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Lymphatics | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Death | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Death | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Non-systematic Assessment |
|
| Death | Hepatobiliary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Death | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Death | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Death | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Blurred vision | Eye disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Peripheral oedema | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Symptomatic bradycardia | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dizziness | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Headache | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Lethargy | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Upper respiratory tract symptoms | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Symptomatic hypotension | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| Mental Component Summary |
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| Physical Function Domain Score |
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| Role Limitation Due to Physical Domain score |
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| Role Limitation Due to Emotional Problems Domain score |
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| Social Functioning Domain Score |
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| Mental Health Domain |
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| Energy/Vitality Domain Score |
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| Pain Score |
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| General Health Perception Domain Score |
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| Missing |
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| Lost to follow-up |
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| Withdrawn consent |
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