Atrial FibrillationPhase 4RATAFIINCT02695992
Rate Control in Atrial Fibrillation II
A Phase 4 study testing Metoprolol and Diltiazem in people with Atrial Fibrillation and Permanent Atrial Fibrillation, run by Asker & Baerum Hospital at 1 site in Norway.
Trial summary
The RATAF II study is a randomized, prospective, parallel group study, designed to compare the effects of two different drug regimens for rate control in permanent AF (atrial fibrillation). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Permanent Atrial Fibrillation
- What is being tested?
- Metoprolol and Diltiazem
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2016to 12 Nov 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Above 18 years of age
- Symptomatic, permanent AF of at least three months duration
- Resting heart rate ≥80 bpm
- Signed informed consent
Who cannot join
- Congestive heart failure
- Ischemic heart disease
- Hypotension (Systolic blood pressure <100 mmHg)
- Treatment with class I or III antiarrhythmic drugs
- Severe hepatic or renal failure
- Pregnancy or lactation
Show all 10Show fewer
- Hypersensitivity or contradictions to study drugs
- Atrio-ventricular conduction disturbances
- Thyrotoxicosis
- Life limiting disease or substance abuse which may affect participation
Trial locations and contacts
1 site in 1 country.
About this study
The RATAF II study is a randomized, prospective, parallel group study, designed to compare the effects of two different drug regimens for rate control in permanent AF (atrial fibrillation). We will investigate on the difference in effects on exercise capacity, biomarkers (NT-proBNP (N-terminal pro-brain natriuretic peptide), troponins, hs-CRP), heart rate, echocardiographic measurements and symptoms.
Our main hypothesis is that six months' treatment with the calcium channel blocker diltiazem will lower NT-proBNP and increase exercise capacity (peak VO2) compared to treatment with the beta blocker metoprolol in permanent AF.
Read the detailed description
Atrial fibrillation is a common cardiac disease, with increasing incidence and prevalence. There are two main treatment strategies for this arrhythmia, rhythm control and rate control. As rate control is easier to achieve and no major difference in outcome has been found between these two strategies, it is considered a reasonable initial treatment for the majority of AF patients.
Reduced exercise capacity is the most prevalent symptom in patients with permanent AF. In the first Rate control in Atrial Fibrillation (RATAF) study, we demonstrated that calcium channel blockers preserved exercise capacity, reduced arrhythmia-related symptoms and lowered levels of NT-proBNP - whereas the beta blockers reduced the exercise capacity, did not reduce arrhythmia-related symptoms and increased NT-proBNP.
These findings are relevant to a large proportion of patients with permanent AF, suggesting that calcium channel blockers should be the first drug of choice for rate control in patients without heart failure or coronary heart disease. Our results challenge the current widespread use of beta blockers in this setting. However, as the follow up time in the RATAF study was only 3 weeks, it is not clear if these effects are sustained over time. Furthermore, we do not know the mechanisms for the differential effects on exercise capacity, arrhythmia related symptoms and NT-proBNP levels.
In the RATAF II study we will investigate whether the effects on NT-proBNP levels, exercise capacity and symptoms are sustained over time, and explore potential mechanisms that may explain the difference in these effects. The study will provide new insights and results relevant for everyday clinical practice and be of importance for a large and growing group of patients.
A total of 240 patients will be included. Eligible patients will be recruited from the out-patient clinics at the participation hospitals and through advertisements in local newspapers. After inclusion and a wash-out period of 14 days free from drugs affecting the heart rate, patients will be examined by echocardiography, 12-lead ECG (electrocardiography), 24h Holter monitoring, maximal cardiopulmonary exercise test and venous blood sampling at rest, at maximal exercise and after recovery. Perceived arrhythmia related symptoms, quality of life and level of physical activity will be assessed using self-administered questionnaires.
Participants will be randomized through a computer-generated randomization list, to receive one of the study drug regimens; metoprolol 100 mg o.d. or diltiazem 360 mg o.d. The investigators and study personnel will be blinded with regard to allocated study drug. The participants themselves will know what study drug they are assigned. Also, study personnel not involved in examinations will also be able to acquire knowledge concerning assigned study drug, to ensure the process of dosage in the startup phase, assess adverse events (AE) and side effects throughout the study.
Examinations will be repeated after four weeks and six months. All examinations will be performed at the Department of Medical Research, Baerum Hospital to ensure standardized procedures.
- Conditions
- Atrial Fibrillation, Permanent Atrial Fibrillation
- Being tested
- Metoprolol, Diltiazem
- Keywords
- Rate control in atrial fibrillation, Beta blockers, Calcium channel blockers, Permanent atrial fibrillation, Management of atrial fibrillation, Atrial fibrillation and biomarkers, Arrhythmias, cardiac, Heart Diseases, Pathological processes, Diltiazem, Metoprolol, Adrenergic Agents, Adrenergic Antagonists, Adrenergic beta-1 Receptor Antagonists, Adrenergic beta-Antagonists, Anti-Arrhythmia Agents, Antihypertensive Agents, Autonomic Agents, Cardiovascular Agents, Membrane Transport Modulators
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac, Heart Diseases, Pathologic Processes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetoprololDrug
Also called Selo-Zok Metoprolol Astra Zeneca depot
Dosage 100 mg o.d.
DiltiazemDrug
Also called Cardizem Diltiazem Uno depot
Dosage 360 mg o.d.
| Study group | Role | What they receive |
|---|---|---|
| Metoprolol | Active comparator | Metoprolol, extended release tablets. 100 mg daily Receives: Drug: Metoprolol |
| Diltiazem | Active comparator | Diltiazem, extended release tablets. 360 mg daily Receives: Drug: Diltiazem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of NT-proBNP
Levels of NT-proBNP will be measured at baseline and after 4 weeks to assess change
Measured: 4 weeks
Levels of NT-proBNP
Levels of NT-proBNP will be measured after 6 months
Measured: 6 months
Secondary outcomes (26)
Exercise capacity defined as peak VO2
Exercise capacity will be assessed by cardiopulmonary exercise test at baseline and after 4 weeks to assess change
Measured: 4 weeks
Exercise capacity defined as peak VO2
Exercise capacity will be assessed by cardiopulmonary exercise test after 6 months
Measured: 6 months
Ventricular heart rate
Ventricular heart rate will be assessed by ECG at rest and during exercise. Will be measured at baseline and after 4 weeks to assess change
Measured: 4 weeks
Ventricular heart rate
Ventricular heart rate will be assessed by ECG at rest and during exercise. Will be measured after 6 months.
Measured: 6 months
Other biomarkers
Levels of other biomarkers such as hs-troponins, hs-CRP will be measured at baseline and after 4 weeks to assess change
Measured: 4 weeks
Other biomarkers
Levels of other biomarkers such as hs-troponins, hs-CRP will be measured after 6 months.
Measured: 6 months
Symptoms
Symptoms will be assessed using a validated, self-administered questionnaire, the Symptom Checklist - Frequency and Severity (SCL). This will be filled out at baseline and 4 weeks to assess change.
Measured: 4 weeks
Symptoms
Symptoms will be assessed using a validated, self-administered questionnaire, the Symptom Checklist - Frequency and Severity (SCL). This will be filled out at 6 months.
Measured: 6 months
Quality of life in SF-36
The SF-36 (Short Form 36 Health Survey) questionnaire assessing quality of life will be filled out at baseline and 4 weeks to assess change.
Measured: 4 weeks
Quality of life in SF-36
The SF-36 questionnaire assessing quality of life will be filled out at 6 months.
Measured: 6 months
Echocardiographic measures - Standard parasternal long axis and three apical views recordings.
Will be done in the end expiratory phase with the subjects in supine lateral position. Will be measured at baseline and after 4 weeks to assess change
Measured: 4 weeks
Echocardiographic measures - Standard parasternal long axis and three apical views recordings.
Will be done in the end expiratory phase with the subjects in supine lateral position. Measured at 6 months.
Measured: 6 months
Echocardiographic measures - Left ventricular dimension, septal and posterior wall thickness.
Will be measured as recommended by American Society of Echocardiography. Will be measured at baseline and after 4 weeks to assess change
Measured: 4 weeks
Echocardiographic measures - Left ventricular dimension, septal and posterior wall thickness.
Will be measured as recommended by American Society of Echocardiography. Measured at 6 months.
Measured: 6 months
Echocardiographic measures - Left ventricular mass.
Will be measured as recommended by American Society of Echocardiography. Will be measured at baseline and after 4 weeks to assess change
Measured: 4 weeks
Echocardiographic measures - Left ventricular mass.
Will be measured as recommended by American Society of Echocardiography. Measured at 6 months.
Measured: 6 months
Echocardiographic measures - Left ventricular and left atrial maximal and minimal volumes.
Will be calculated by 2D biplane and 4-chamber and 2D long axis views. (ml/m2). Will be measured at baseline and after 4 weeks to assess change
Measured: 4 weeks
Echocardiographic measures - Left ventricular and left atrial maximal and minimal volumes.
Will be calculated by 2D biplane and 4-chamber and 2D long axis views. (ml/m2). Measured at 6 months.
Measured: 6 months
Echocardiographic measures - Left ventricular ejection fraction will also be calculated.
Using the modified Simpsons rule. Will be measured at baseline and after 4 weeks to assess change
Measured: 4 weeks
Echocardiographic measures - Left ventricular ejection fraction will also be calculated.
Using the modified Simpsons rule. Measured at 6 months.
Measured: 6 months
Echocardiographic measures - Transmitral flow and pulmonary venous flow.
Will be assessed by pulsed Doppler. Tissue Doppler imaging-derived indices will be recorded at the base of the septal and lateral mitral annulus. (cm/s). Will be measured at baseline and after 4 weeks to assess change
Measured: 4 weeks
Echocardiographic measures - Transmitral flow and pulmonary venous flow.
Will be assessed by pulsed Doppler. Tissue Doppler imaging-derived indices will be recorded at the base of the septal and lateral mitral annulus. (cm/s). Measured at 6 months.
Measured: 6 months
Echocardiographic measures - Global and regional longitudinal left ventricular strain.
Will be analysed by a semi-automated speckle tracking technique. Will be measured at baseline and after 4 weeks to assess change
Measured: 4 weeks
Echocardiographic measures - Global and regional longitudinal left ventricular strain.
Will be analysed by a semi-automated speckle tracking technique.Measured at 6 months.
Measured: 6 months
Echocardiographic measures - Left atrial deformation for assessment of global as well as regional left atrial strain.
Will be analysed by a semi-automated speckle tracking technique. Characterizing both reservoir and conduit function. Will be measured at baseline and after 4 weeks to assess change
Measured: 4 weeks
Echocardiographic measures - Left atrial deformation for assessment of global as well as regional left atrial strain.
Will be analysed by a semi-automated speckle tracking technique. Characterizing both reservoir and conduit function. Measured at 6 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionOct 2021
- Study completion12 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asker & Baerum Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Vestre Viken Hospital Trust, Helse Sor-Ost
- Responsible party
- Principal investigator, Sara Reinvik Ulimoen, Asker & Baerum Hospital
- Investigators
- Sara Reinvik Ulimoen, MD PhD, Principal investigator, Vestre Viken HF Baerum Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02695992
- Sponsor's protocol ID
- 240415
- Other IDs
- 2015-001918-98, 2015
- Acronym
- RATAFII
- Status last verified
- Jan 2022
- First submitted
- 28 Apr 2015
- Last updated
- 5 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Ulimoen SR, Enger S, Pripp AH, Abdelnoor M, Arnesen H, Gjesdal K, Tveit A. Calcium channel blockers improve exercise capacity and reduce N-terminal Pro-B-type natriuretic peptide levels compared with beta-blockers in patients with permanent atrial fibrillation. Eur Heart J. 2014 Feb;35(8):517-24. doi: 10.1093/eurheartj/eht429. Epub 2013 Oct 17.
PubMed 24135831Ulimoen SR, Enger S, Carlson J, Platonov PG, Pripp AH, Abdelnoor M, Arnesen H, Gjesdal K, Tveit A. Comparison of four single-drug regimens on ventricular rate and arrhythmia-related symptoms in patients with permanent atrial fibrillation. Am J Cardiol. 2013 Jan 15;111(2):225-30. doi: 10.1016/j.amjcard.2012.09.020. Epub 2012 Oct 27.
PubMed 23111138Go AS, Hylek EM, Phillips KA, Chang Y, Henault LE, Selby JV, Singer DE. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA. 2001 May 9;285(18):2370-5. doi: 10.1001/jama.285.18.2370.
PubMed 11343485Van Gelder IC, Groenveld HF, Crijns HJ, Tuininga YS, Tijssen JG, Alings AM, Hillege HL, Bergsma-Kadijk JA, Cornel JH, Kamp O, Tukkie R, Bosker HA, Van Veldhuisen DJ, Van den Berg MP; RACE II Investigators. Lenient versus strict rate control in patients with atrial fibrillation. N Engl J Med. 2010 Apr 15;362(15):1363-73. doi: 10.1056/NEJMoa1001337. Epub 2010 Mar 15.
PubMed 20231232European Heart Rhythm Association; European Association for Cardio-Thoracic Surgery; Camm AJ, Kirchhof P, Lip GY, Schotten U, Savelieva I, Ernst S, Van Gelder IC, Al-Attar N, Hindricks G, Prendergast B, Heidbuchel H, Alfieri O, Angelini A, Atar D, Colonna P, De Caterina R, De Sutter J, Goette A, Gorenek B, Heldal M, Hohloser SH, Kolh P, Le Heuzey JY, Ponikowski P, Rutten FH. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Eur Heart J. 2010 Oct;31(19):2369-429. doi: 10.1093/eurheartj/ehq278. Epub 2010 Aug 29. No abstract available.
PubMed 20802247Ulimoen SR, Enger S, Norseth J, Pripp AH, Abdelnoor M, Arnesen H, Gjesdal K, Tveit A. Improved rate control reduces cardiac troponin T levels in permanent atrial fibrillation. Clin Cardiol. 2014 Jul;37(7):422-7. doi: 10.1002/clc.22281. Epub 2014 Apr 3.
PubMed 24700386Van Gelder IC, Hobbelt AH, Mulder BA, Rienstra M. Rate control in atrial fibrillation: many questions still unanswered. Circulation. 2015 Oct 27;132(17):1597-9. doi: 10.1161/CIRCULATIONAHA.115.018952. Epub 2015 Sep 17. No abstract available.
PubMed 26384161Enge K, Ulimoen SR, Enger S, Onarheim S, Olufsen M, Pripp AH, Steinsvik T, Hall C, Hetland M, Tveit A. Effects of diltiazem and metoprolol on levels of high-sensitivity troponin I in patients with permanent atrial fibrillation: a randomized trial. BMC Cardiovasc Disord. 2025 Mar 14;25(1):181. doi: 10.1186/s12872-025-04574-2.
PubMed 40087560
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rate Control in Atrial Fibrillation II
- ClinicalTrials.gov ID
- NCT02695992
- Acronym / sponsor ID
- RATAFII / 240415
- Conditions
- Atrial Fibrillation, Permanent Atrial Fibrillation
- Keywords
- Rate control in atrial fibrillation, Beta blockers, Calcium channel blockers, Permanent atrial fibrillation, Management of atrial fibrillation, Atrial fibrillation and biomarkers, Arrhythmias, cardiac, Heart Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Asker & Baerum HospitalUniversity, hospital or other
- Collaborators
- Vestre Viken Hospital Trust, Helse Sor-Ost
- Study start
- Feb 2016
- Primary completion
- Oct 2021 (actual)
- Study completion
- 12 Nov 2021 (actual)
- First posted
- 2 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The RATAF II study is a randomized, prospective, parallel group study, designed to compare the effects of two different drug regimens for rate control in permanent AF (atrial fibrillation). We will investigate on the difference in effects on exercise capacity, biomarkers (NT-proBNP (N-terminal pro-brain natriuretic peptide), troponins, hs-CRP), heart rate, echocardiographic measurements and symptoms.
Our main hypothesis is that six months' treatment with the calcium channel blocker diltiazem will lower NT-proBNP and increase exercise capacity (peak VO2) compared to treatment with the beta blocker metoprolol in permanent AF.
Detailed description
Atrial fibrillation is a common cardiac disease, with increasing incidence and prevalence. There are two main treatment strategies for this arrhythmia, rhythm control and rate control. As rate control is easier to achieve and no major difference in outcome has been found between these two strategies, it is considered a reasonable initial treatment for the majority of AF patients.
Reduced exercise capacity is the most prevalent symptom in patients with permanent AF. In the first Rate control in Atrial Fibrillation (RATAF) study, we demonstrated that calcium channel blockers preserved exercise capacity, reduced arrhythmia-related symptoms and lowered levels of NT-proBNP - whereas the beta blockers reduced the exercise capacity, did not reduce arrhythmia-related symptoms and increased NT-proBNP.
These findings are relevant to a large proportion of patients with permanent AF, suggesting that calcium channel blockers should be the first drug of choice for rate control in patients without heart failure or coronary heart disease. Our results challenge the current widespread use of beta blockers in this setting. However, as the follow up time in the RATAF study was only 3 weeks, it is not clear if these effects are sustained over time. Furthermore, we do not know the mechanisms for the differential effects on exercise capacity, arrhythmia related symptoms and NT-proBNP levels.
In the RATAF II study we will investigate whether the effects on NT-proBNP levels, exercise capacity and symptoms are sustained over time, and explore potential mechanisms that may explain the difference in these effects. The study will provide new insights and results relevant for everyday clinical practice and be of importance for a large and growing group of patients.
A total of 240 patients will be included. Eligible patients will be recruited from the out-patient clinics at the participation hospitals and through advertisements in local newspapers. After inclusion and a wash-out period of 14 days free from drugs affecting the heart rate, patients will be examined by echocardiography, 12-lead ECG (electrocardiography), 24h Holter monitoring, maximal cardiopulmonary exercise test and venous blood sampling at rest, at maximal exercise and after recovery. Perceived arrhythmia related symptoms, quality of life and level of physical activity will be assessed using self-administered questionnaires.
Participants will be randomized through a computer-generated randomization list, to receive one of the study drug regimens; metoprolol 100 mg o.d. or diltiazem 360 mg o.d. The investigators and study personnel will be blinded with regard to allocated study drug. The participants themselves will know what study drug they are assigned. Also, study personnel not involved in examinations will also be able to acquire knowledge concerning assigned study drug, to ensure the process of dosage in the startup phase, assess adverse events (AE) and side effects throughout the study.
Examinations will be repeated after four weeks and six months. All examinations will be performed at the Department of Medical Research, Baerum Hospital to ensure standardized procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metoprolol | Active comparator | Drug: MetoprololMetoprolol, extended release tablets. 100 mg daily |
| Diltiazem | Active comparator | Drug: DiltiazemDiltiazem, extended release tablets. 360 mg daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Above 18 years of age
- Symptomatic, permanent AF of at least three months duration
- Resting heart rate ≥80 bpm
- Signed informed consent
Key exclusion criteria (10 listed)
- Congestive heart failure
- Ischemic heart disease
- Hypotension (Systolic blood pressure <100 mmHg)
- Treatment with class I or III antiarrhythmic drugs
- Severe hepatic or renal failure
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 |
|---|---|---|
| MetoprololAlso: Selo-Zok Metoprolol Astra Zeneca depotDosage 100 mg o.d. | Drug | Metoprolol |
| DiltiazemAlso: Cardizem Diltiazem Uno depotDosage 360 mg o.d. | Drug | Diltiazem |
Primary outcome
Levels of NT-proBNP
Time frame: 4 weeks
Levels of NT-proBNP will be measured at baseline and after 4 weeks to assess change
Levels of NT-proBNP
Time frame: 6 months
Levels of NT-proBNP will be measured after 6 months
26 secondary outcomes
Exercise capacity defined as peak VO2
Time frame: 4 weeks
Exercise capacity defined as peak VO2
Time frame: 6 months
Ventricular heart rate
Time frame: 4 weeks
Ventricular heart rate
Time frame: 6 months
Other biomarkers
Time frame: 4 weeks
Other biomarkers
Time frame: 6 months
Symptoms
Time frame: 4 weeks
Symptoms
Time frame: 6 months
Quality of life in SF-36
Time frame: 4 weeks
Quality of life in SF-36
Time frame: 6 months
Echocardiographic measures - Standard parasternal long axis and three apical views recordings.
Time frame: 4 weeks
Echocardiographic measures - Standard parasternal long axis and three apical views recordings.
Time frame: 6 months
Echocardiographic measures - Left ventricular dimension, septal and posterior wall thickness.
Time frame: 4 weeks
Echocardiographic measures - Left ventricular dimension, septal and posterior wall thickness.
Time frame: 6 months
Echocardiographic measures - Left ventricular mass.
Time frame: 4 weeks
Echocardiographic measures - Left ventricular mass.
Time frame: 6 months
Echocardiographic measures - Left ventricular and left atrial maximal and minimal volumes.
Time frame: 4 weeks
Echocardiographic measures - Left ventricular and left atrial maximal and minimal volumes.
Time frame: 6 months
Echocardiographic measures - Left ventricular ejection fraction will also be calculated.
Time frame: 4 weeks
Echocardiographic measures - Left ventricular ejection fraction will also be calculated.
Time frame: 6 months
Echocardiographic measures - Transmitral flow and pulmonary venous flow.
Time frame: 4 weeks
Echocardiographic measures - Transmitral flow and pulmonary venous flow.
Time frame: 6 months
Echocardiographic measures - Global and regional longitudinal left ventricular strain.
Time frame: 4 weeks
Echocardiographic measures - Global and regional longitudinal left ventricular strain.
Time frame: 6 months
Echocardiographic measures - Left atrial deformation for assessment of global as well as regional left atrial strain.
Time frame: 4 weeks
Echocardiographic measures - Left atrial deformation for assessment of global as well as regional left atrial strain.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
- Background: PubMed 24135831Ulimoen SR, Enger S, Pripp AH, Abdelnoor M, Arnesen H, Gjesdal K, Tveit A. Calcium channel blockers improve exercise capacity and reduce N-terminal Pro-B-type natriuretic peptide levels compared with beta-blockers in patients with permanent atrial fibrillation. Eur Heart J. 2014 Feb;35(8):517-24. doi: 10.1093/eurheartj/eht429. Epub 2013 Oct 17.
- Background: PubMed 23111138Ulimoen SR, Enger S, Carlson J, Platonov PG, Pripp AH, Abdelnoor M, Arnesen H, Gjesdal K, Tveit A. Comparison of four single-drug regimens on ventricular rate and arrhythmia-related symptoms in patients with permanent atrial fibrillation. Am J Cardiol. 2013 Jan 15;111(2):225-30. doi: 10.1016/j.amjcard.2012.09.020. Epub 2012 Oct 27.
- Background: PubMed 11343485Go AS, Hylek EM, Phillips KA, Chang Y, Henault LE, Selby JV, Singer DE. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA. 2001 May 9;285(18):2370-5. doi: 10.1001/jama.285.18.2370.
- Background: PubMed 20231232Van Gelder IC, Groenveld HF, Crijns HJ, Tuininga YS, Tijssen JG, Alings AM, Hillege HL, Bergsma-Kadijk JA, Cornel JH, Kamp O, Tukkie R, Bosker HA, Van Veldhuisen DJ, Van den Berg MP; RACE II Investigators. Lenient versus strict rate control in patients with atrial fibrillation. N Engl J Med. 2010 Apr 15;362(15):1363-73. doi: 10.1056/NEJMoa1001337. Epub 2010 Mar 15.
- Background: PubMed 20802247European Heart Rhythm Association; European Association for Cardio-Thoracic Surgery; Camm AJ, Kirchhof P, Lip GY, Schotten U, Savelieva I, Ernst S, Van Gelder IC, Al-Attar N, Hindricks G, Prendergast B, Heidbuchel H, Alfieri O, Angelini A, Atar D, Colonna P, De Caterina R, De Sutter J, Goette A, Gorenek B, Heldal M, Hohloser SH, Kolh P, Le Heuzey JY, Ponikowski P, Rutten FH. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Eur Heart J. 2010 Oct;31(19):2369-429. doi: 10.1093/eurheartj/ehq278. Epub 2010 Aug 29. No abstract available.
- Background: PubMed 24700386Ulimoen SR, Enger S, Norseth J, Pripp AH, Abdelnoor M, Arnesen H, Gjesdal K, Tveit A. Improved rate control reduces cardiac troponin T levels in permanent atrial fibrillation. Clin Cardiol. 2014 Jul;37(7):422-7. doi: 10.1002/clc.22281. Epub 2014 Apr 3.
- Background: PubMed 26384161Van Gelder IC, Hobbelt AH, Mulder BA, Rienstra M. Rate control in atrial fibrillation: many questions still unanswered. Circulation. 2015 Oct 27;132(17):1597-9. doi: 10.1161/CIRCULATIONAHA.115.018952. Epub 2015 Sep 17. No abstract available.
- Derived from this study: PubMed 40087560Enge K, Ulimoen SR, Enger S, Onarheim S, Olufsen M, Pripp AH, Steinsvik T, Hall C, Hetland M, Tveit A. Effects of diltiazem and metoprolol on levels of high-sensitivity troponin I in patients with permanent atrial fibrillation: a randomized trial. BMC Cardiovasc Disord. 2025 Mar 14;25(1):181. doi: 10.1186/s12872-025-04574-2.
- 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.
Sara Reinvik Ulimoen, MD PhD principal investigator
Vestre Viken HF Baerum Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metoprolol and Diltiazem in people with Atrial Fibrillation and Permanent Atrial Fibrillation, run by Asker & Baerum Hospital at 1 site in Norway.
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 10 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 5 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Levels of NT-proBNP (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 NCT02695992, which also lists 8 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 5 Jan 2022.