Determinants of label non-adherence to non-vitamin K oral anticoagulants in patients with newly diagnosed atrial fibrillation.

Aims: To evaluate the extent and determinants of off-label non-vitamin K oral anticoagulant (NOAC) dosing in newly diagnosed Dutch AF patients. Methods and results: In the DUTCH-AF registry, patients with newly diagnosed AF (<6 months) are prospectively enrolled. Label adherence to NOAC dosing was assessed using the European Medicines Agency labelling. Factors associated with off-label dosing were explored by multivariable logistic regression analyses. From July 2018 to November 2020, 4500 patients were registered. The mean age was 69.6 ± 10.5 years, and 41.5% were female. Of the 3252 patients in which NOAC label adherence could be assessed, underdosing and overdosing were observed in 4.2% and 2.4%, respectively. In 2916 (89.7%) patients with a full-dose NOAC recommendation, 4.6% were underdosed, with a similar distribution between NOACs. Independent determinants (with 95% confidence interval) were higher age [odds ratio (OR): 1.01 per year, 1.01-1.02], lower renal function (OR: 0.96 per ml/min/1.73 m2, 0.92-0.98), lower weight (OR: 0.98 per kg, 0.97-1.00), active malignancy (OR: 2.46, 1.19-5.09), anaemia (OR: 1.73, 1.08-2.76), and concomitant use of antiplatelets (OR: 4.93, 2.57-9.46). In the 336 (10.3%) patients with a reduced dose NOAC recommendation, 22.9% were overdosed, most often with rivaroxaban. Independent determinants were lower age (OR: 0.92 per year, 0.88-0.96) and lower renal function (OR: 0.98 per ml/min/1.73 m2, 0.96-1.00). Conclusion: In newly diagnosed Dutch AF patients, off-label dosing of NOACs was seen in only 6.6% of patients, most often underdosing. In this study, determinants of off-label dosing were age, renal function, weight, anaemia, active malignancy, and concomitant use of antiplatelets.

Age is the main determinant of COVID-19 related in-hospital mortality with minimal impact of pre-existing comorbidities, a retrospective cohort study.

BACKGROUND: Age and comorbidities increase COVID-19 related in-hospital mortality risk, but the extent by which comorbidities mediate the impact of age remains unknown. METHODS: In this multicenter retrospective cohort study with data from 45 Dutch hospitals, 4806 proven COVID-19 patients hospitalized in Dutch hospitals (between February and July 2020) from the CAPACITY-COVID registry were included (age 69[58-77]years, 64% men). The primary outcome was defined as a combination of in-hospital mortality or discharge with palliative care. Logistic regression analysis was performed to analyze the associations between sex, age, and comorbidities with the primary outcome. The effect of comorbidities on the relation of age with the primary outcome was evaluated using mediation analysis. RESULTS: In-hospital COVID-19 related mortality occurred in 1108 (23%) patients, 836 (76%) were aged ≥70 years (70+). Both age 70+ and female sex were univariably associated with outcome (odds ratio [OR]4.68, 95%confidence interval [4.02-5.45], OR0.68[0.59-0.79], respectively;both p<  0.001). All comorbidities were univariably associated with outcome (p<0.001), and all but dyslipidemia remained significant after adjustment for age70+ and sex. The impact of comorbidities was attenuated after age-spline adjustment, only leaving female sex, diabetes mellitus (DM), chronic kidney disease (CKD), and chronic pulmonary obstructive disease (COPD) significantly associated (female OR0.65[0.55-0.75], DM OR1.47[1.26-1.72], CKD OR1.61[1.32-1.97], COPD OR1.30[1.07-1.59]). Pre-existing comorbidities in older patients negligibly (<6% in all comorbidities) mediated the association between higher age and outcome. CONCLUSIONS: Age is the main determinant of COVID-19 related in-hospital mortality, with negligible mediation effect of pre-existing comorbidities. TRIAL REGISTRATION: CAPACITY-COVID ( NCT04325412 ).

Heart rate increase and inappropriate sinus tachycardia after cryoballoon pulmonary vein isolation for atrial fibrillation.

BACKGROUND: Cryoballoon pulmonary vein isolation (PVI) is a common therapy for atrial fibrillation (AF). While moderately increased sinus rhythm heart rate (HR) after PVI has been observed, inappropriate sinus tachycardia (IST) is a rare phenomenon. We aimed to investigate the prevalence and natural history of an abnormal sinus HR response after cryoballoon PVI. METHODS: We included 169/646 (26.2%) patients with AF undergoing PVI with available Holter recordings before and 3, 6 and 12 months after the procedure. Patients with AF on Holter monitoring were excluded. Mean HR increase ≥ 20 bpm or an IST-like pattern (mean HR > 90 bpm or > 80 bpm when beta-blocking agents were used) following PVI was categorised as abnormal sinus HR response. RESULTS: Following PVI, mean HR ± standard deviation increased in the entire group from 63.5 ± 8.4 to 69.1 ± 9.9 bpm at 3 months (p < 0.001), and to 71.9 ± 9.4 bpm at 6 months (p < 0.001). At 12 months, mean HR was 71.2 ± 10.1 bpm (p < 0.001). Only 7/169 patients (4.1%) met criteria for abnormal sinus HR response: mean HR was 61.9 ± 10.6 bpm (pre-ablation), 84.6 ± 9.8 bpm (3 months), 80.1 ± 6.5 bpm (6 months) and 76.3 ± 10.1 bpm (12 months). Even at 12 months, mean HR was significantly different from that pre-ablation in this group (p = 0.033). However, in patients meeting IST-like pattern criteria, mean HR at 12 months was no longer significantly different from that pre-ablation. CONCLUSION: Few patients had an abnormal sinus HR response after PVI. Peak HR was observed 3 months after PVI, but HR was still significantly increased 12 months post-ablation compared with pre-ablation. An IST-like pattern was rarely observed. In these patients, HR decreased to pre-ablation values within a year.

Screening for Atrial Fibrillation in Sub-Saharan Africa: A Health Economic Evaluation to Assess the Feasibility in Nigeria.

Background: Cardiovascular disease reflects a major burden of non-communicable disease in Sub-Saharan Africa (SSA). Early detection and treatment of atrial fibrillation (AF), as a preventive measure against stroke, is currently not in the scope of the World Health Organization recommendation to reduce cardiovascular disease. Objective: We hypothesized that screening for AF would be an important approach to determine the true AF prevalence in the general population in African countries and to identify asymptomatic AF patients at risk for stroke to optimize prevention. Methods: A decision analytic model was developed to study the health-economic impact of AF screening in Nigeria over a life-time horizon. The patient population explored in the model was a population of newly detected AF cases that would be diagnosed with a one-time systematic screening for AF with a single lead ECG device in community health centres across Nigeria. Conclusions: The health gain per newly detected AF patient (N = 31,687) was 0.41 QALY at a cost of $5,205 per patient with 100% NOAC use, leading to an ICER of $12,587 per QALY gained. The intervention was cost-effective with a 99.9% warfarin use with an ICER of $1,363 per QALY gained. The total cost of a single screening session was $7.3 million for the total screened population in Nigeria or $1.60 per patient screened. Screening for AF to detect AF patients in need for stroke prevention can be a cost-effective intervention in the Sub-Saharan region, depending on type of anticoagulant used and drug costs.

Effect of anticoagulant therapy in COVID-19 patients.

BACKGROUND: In patients hospitalised with COVID-19, an increased incidence of thromboembolic events, such as pulmonary embolism, deep vein thrombosis and stroke, has been reported. It is unknown whether anticoagulation can prevent these complications and improve outcome. METHODS: A systematic literature search was performed to answer the question: What is the effect of (prophylactic and therapeutic dose) anticoagulation therapy in COVID-19 patients on cardiovascular and thromboembolic complications and clinical outcome? Relevant outcome measures were mortality (crucial), hospital admission, length of stay, thromboembolic complications (pulmonary embolism, stroke, transient ischaemic attack), need for mechanical ventilation, acute kidney injury and use of renal replacement therapy. Medline and Embase databases were searched with relevant search terms until 17 July 2020. After systematic analysis, eight studies were included. Analysis was stratified for the start of anticoagulation before or during hospital admission. RESULTS: There was insufficient evidence that therapeutic anticoagulation could improve the outcome in patients hospitalised with COVID-19. None of the studies demonstrated improved mortality, except for one very small Italian study. Furthermore, none of the studies showed a positive effect of anticoagulation on other outcome measures in COVID-19, such as ICU admission, length of hospital stay, thromboembolic complications, need for mechanical ventilation, acute kidney failure or need for renal replacement therapy, except for two studies demonstrating an association between anticoagulation and a lower incidence of pulmonary embolism. However, the level of evidence of all studies varied from 'low' to 'very low', according to the GRADE methodology. CONCLUSION: Analysis of the literature showed that there was insufficient evidence to answer our objective on the effect of anticoagulation on outcome in COVID-19 patients, especially due to the low scientific quality of the described studies. Randomised controlled studies are needed to answer this question.

Idiopathic atrial fibrillation patients rapidly outgrow their low thromboembolic risk: a 10-year follow-up study.

BACKGROUND: Healthy atrial fibrillation (AF) patients will eventually outgrow their low thromboembolic risk. The purpose of this study is to compare the development of cardiovascular disease in healthy AF patients as compared to healthy sinus rhythm patients and to assess appropriate anticoagulation treatment. METHODS: Forty-one idiopathic paroxysmal AF patients (56 ± 10 years, 66% male) were compared with 45 healthy sinus rhythm patients. Patients were free of hypertension, antihypertensive and antiarrhythmic drugs, diabetes, congestive heart failure, coronary artery or peripheral vascular disease, previous stroke, thyroid, pulmonary and renal disease, and structural abnormalities on echocardiography. RESULTS: Baseline characteristics and echocardiographic parameters were the same in both groups. During 10.7 ± 1.6 years, cardiovascular disease and all-cause death developed significantly more often in AF patients as compared to controls (63% vs 31%, log rank p < 0.001). Even after the initial 5 years of follow-up, survival curves show divergent patterns (log rank p = 0.006). Mean duration to reach a CHA2DS2-VASc score > 1 among AF patients was 5.1 ± 3.0 years. Five of 24 (21%) patients with CHA2DS2-VASc > 1 did not receive oral anticoagulation therapy at follow-up. Mean duration of over- or undertreatment with oral anticoagulation in patients with CHA2DS2-VASc > 1 was 5 ± 3.0 years. CONCLUSION: The majority of recently diagnosed healthy AF patients develop cardiovascular diseases with a consequent change in thromboembolic risk profile within a short time frame. A comprehensive follow-up of this patient category is necessary to avoid over- and undertreatment with anticoagulants.

Inappropriate non-vitamin K antagonist oral anticoagulants prescriptions: be cautious with dose reductions.

BACKGROUND: Non-vitamin K antagonist oral anticoagulants (NOACs) are prescribed to patients with atrial fibrillation (AF) to reduce the risk of stroke. Prescribing the correct dose warrants careful consideration of the prevailing dose criteria that differ per NOAC. Electronic systems are useful to intercept prescriptions that are incorrect based on simple 'primary' criteria, for example dosing frequency and drug-drug interactions with concomitant medication. However, these systems do not take into account patient characteristics such as age, renal function or weight, which are crucial elements to determine the NOAC dose. METHODS: Our goal was to determine the appropriateness of all prescriptions, as compared with the product labelling approved by the European Medicines Agency, to address common pitfalls in prescribing NOACs. AF patients with a first NOAC prescription between January 2012 and December 2016 were identified from our electronic hospital information system (Martini Hospital, Groningen, the Netherlands). RESULTS: The study included 3,231 AF patients who had started on an NOAC; 10.7% received an inappropriate dose and the appropriateness of the prescription could not be determined in 14.1%. Underdosing and overdosing occurred in 5.4% and 4.5% of all prescriptions, respectively. A reduced-dose NOAC was a predictor for incorrect prescribing (odds ratio: 2.70, 95% confidence interval: 2.13-3.41). Patient factors were identified that predicted incorrect prescriptions for dabigatran and apixaban. CONCLUSION: An incorrect prescription occurred more often in the reduced-dose NOAC group. Clinical parameters such as renal function are often unknown whilst these are essential to determine the right NOAC and dose.

Optimal antithrombotic treatment of patients with atrial fibrillation undergoing percutaneous coronary intervention: triple therapy is too much!

Patients with atrial fibrillation who undergo a coronary intervention are eligible for both anticoagulation and (dual) antiplatelet therapy ((D)APT). An optimal balance has to be found to reduce the thromboembolic risk (i.e. stroke, systemic embolism and myocardial infarction) and to minimise the increased risk of bleeding with concomitant use of an anticoagulant and (D)APT. Owing to a lack of evidence, the guideline recommendations are predominantly based on expert opinion. Current evidence indicates that the combination of a non-vitamin K oral anticoagulant (NOAC) and clopidogrel is safer than vitamin-K oral antagonists plus DAPT, which increases the risk of bleeding, without clear advantages in regard to efficacy. Concerning whether (N)OACs should be combined with single APT rather than DAPT, the findings of the WOEST, PIONEER AF-PCI and RE-DUAL PCI trials seem to favour a combination with clopidogrel only, thus omitting aspirin. Choosing the optimal treatment strategies for individual patients on NOACs and (D)APT will remain a challenge for clinicians, though triple therapy seems to be the less favourable option owing to the increased risk of bleeding.

Predictors for total hospital and cardiology cost claims among patients with atrial fibrillation initiating dabigatran or acenocoumarol in The Netherlands.

AIMS: The prevalence of atrial fibrillation (AF) has increased over the past years due to aging of the population, and healthcare costs associated with AF reflect a significant financial burden. The aim of this study was to explore predictors for the real-world AF-related in-hospital costs in patients that recently initiated anticoagulation with acenocoumarol or dabigatran. METHODS: Predictors for claimed total hospital care costs and cardiology costs in AF patients were explored by using hospital financial claims data from propensity score matched patient groups in a large Dutch community hospital. This study analyzed the total dataset (n = 766) and carried out a secondary analysis for all matched pairs of anticoagulation naïve AF patients (n = 590) by ordinal regression. RESULTS: Dabigatran was a predictor for significantly lower cardiology and total hospital care costs (Odds Ratio [OR] = 0.43, 95% confidence interval (CI) = 0.33-0.57; and OR = 0.60, 95% CI = 0.46-0.79, respectively). Female gender was a predictor for lower total hospital care costs. Predictors for an increase in total hospital care costs were the occurrence of stroke or systemic embolism, major bleeding, and minor bleeding. The costs predictors were comparable when limiting the analysis to patients that were anticoagulation naïve. Age and CHA2DS2-VASc were not predictors for either cardiology or total hospital care costs in both analyses. CONCLUSION: Dabigatran treatment was as a predictor for lower cardiology costs and lower total hospital care costs in AF patients that initiated oral anticoagulation.

Validation and clinical use of a novel diagnostic device for screening of atrial fibrillation.

AIMS: Patients with asymptomatic and undiagnosed atrial fibrillation (AF) are at increased risk of heart failure and ischaemic stroke. In this study, we validated a new diagnostic device, the MyDiagnostick, for detection of AF by general practitioners and patients. It records and stores a Lead I electrocardiogram (ECG) which is automatically analysed for the presence of AF. METHODS AND RESULTS: In total, 192 patients (age 69.4 ± 12.6 years) were asked to hold the MyDiagnostick for 1 min, immediately before a routine 12-lead ECG was recorded. Atrial fibrillation detection and ECGs stored by the MyDiagnostick were compared with the cardiac rhythm on the 12-lead ECG. In a second part of the study, the MyDiagnostick was used to screen for AF during influenza vaccination in the general practitioner's office. Atrial fibrillation was present in 53 out of the 192 patients (27.6%). All AF patients were correctly detected by the MyDiagnostick (sensitivity 100%; 95% confidence interval 93-100%). MyDiagnostick AF classification in 6 out of 139 patients in sinus rhythm was considered false positive (specificity 95.9%; 95% confidence interval 91.3-98.1%). During 4 h of influenza vaccination in 676 patients (age 74 ± 7.1 years), the MyDiagnostick correctly diagnosed AF in all 55 patients (prevalence 8.1%). In 11 patients (1.6%), AF was not diagnosed before, all with a CHA2DS2VASc score of >1. CONCLUSION: The high AF detection performance of the MyDiagnostick, combined with the ease of use of the device, enables large screening programmes for detection of undiagnosed AF.

Routine versus aggressive upstream rhythm control for prevention of early atrial fibrillation in heart failure: background, aims and design of the RACE 3 study.

BACKGROUND: Rhythm control for atrial fibrillation (AF) is cumbersome because of its progressive nature caused by structural remodelling. Upstream therapy refers to therapeutic interventions aiming to modify the atrial substrate, leading to prevention of AF. OBJECTIVE: The Routine versus Aggressive upstream rhythm Control for prevention of Early AF in heart failure (RACE 3) study hypothesises that aggressive upstream rhythm control increases persistence of sinus rhythm compared with conventional rhythm control in patients with early AF and mild-to-moderate early systolic or diastolic heart failure undergoing electrical cardioversion. DESIGN: RACE 3 is a prospective, randomised, open, multinational, multicenter trial. Upstream rhythm control consists of angiotensin converting enzyme inhibitors and/or angiotensin receptor blockers, mineralocorticoid receptor antagonists, statins, cardiac rehabilitation therapy, and intensive counselling on dietary restrictions, exercise maintenance, and drug adherence. Conventional rhythm control consists of routine rhythm control therapy without cardiac rehabilitation therapy and intensive counselling. In both arms, every effort is made to keep patients in the rhythm control strategy, and ion channel antiarrhythmic drugs or pulmonary vein ablation may be instituted if AF relapses. Total inclusion will be 250 patients. If upstream therapy proves to be effective in improving maintenance of sinus rhythm, it could become a new approach to rhythm control supporting conventional pharmacological and non-pharmacological rhythm control.

The occurrence of cardiovascular disease during 5-year follow-up in patients with idiopathic atrial fibrillation.

AIMS: Idiopathic atrial fibrillation (AF) may be an expression of as yet undetected underlying heart disease. We found it useful for clinical practice to study the long-term development of cardiovascular disease (CVD) in patients diagnosed with idiopathic AF. METHODS AND RESULTS: Forty-one consecutive idiopathic AF patients (56 ± 10 years, 66% male) were compared with 45 healthy control patients in permanent sinus rhythm. Patients were free of hypertension, antihypertensive and antiarrhythmic drugs, diabetes, congestive heart failure, coronary artery or peripheral vascular disease, previous stroke, thyroid, pulmonary and renal disease, and structural abnormalities on echocardiography. Baseline characteristics and echocardiographic parameters were equal in AF cases and controls. During a mean follow-up of 66 ± 11 months, CVD occurred significantly more often in idiopathic AF patients compared with controls (49 vs. 20%, P= 0.006). Patients with idiopathic AF were significantly younger at the time of their first CV event compared with controls (59 ± 9 vs. 64 ± 5 years, P= 0.027), and had more severe disease. Multivariable Cox regression analysis revealed that age, a history of AF, and echocardiographic left ventricular wall width were significant predictors of CVD development. CONCLUSION: Patients originally diagnosed with idiopathic AF develop CVD more often, at younger age, and with a more severe disease profile compared with healthy sinus rhythm control patients. The detection and treatment of CVD in an early stage could improve the prognosis of these patients. At present it seems prudent to regularly check idiopathic AF patients for the insidious development of CVD.

Feasibility of TEE-guided stroke risk assessment in atrial fibrillation-background, aims, design and baseline data of the TIARA pilot study.

BACKGROUND: Antithrombotic management in atrial fibrillation (AF) is currently based on clinical characteristics, despite evidence of potential fine-tuning with transoesophageal echocardiography (TEE). This open, randomised, multicentre study addresses the hypothesis that a comprehensive strategy of TEE-based aspirin treatment in AF patients is feasible and safe. METHODS: Between 2005 and 2009, ten large hospitals in the Netherlands enrolled AF patients with a moderate risk of stroke. Patients without thrombogenic TEE characteristics were randomised to aspirin or vitamin K antagonists (VKA). The primary objective is to show that TEE-based aspirin treatment is safe compared with VKA therapy. The secondary objective tests feasibility of TEE as a tool to detect echocardiographic features of high stroke risk. This report compares randomised to non-randomised patients and describes the feasibility of a TEE-based approach. RESULTS: In total, 310 patients were included. Sixty-nine patients were not randomised because of non-visualisation (n = 6) or TEE risk factors (n = 63). Compared with non-randomised patients, randomised patients (n = 241) were younger (65 ± 11 vs. 69 ± 9 years, p = 0.004), had less coronary artery disease (9 vs. 20%, p = 0.018), previous TIA (1.7 vs. 7.2%, p = 0.029), AF during TEE (25 vs. 54%, p < 0.001), mitral incompetence (55 vs. 70%, p = 0.038), VKA use (69 vs. 82%, p = 0.032), had a lower mean CHADS(2) score (1.2 ± 0.6 vs. 1.6 ± 1.0, p = 0.004), and left ventricular ejection fraction (59 ± 8 vs. 56 ± 8%, p = 0.016). CONCLUSIONS: This study shows that a TEE-based approach for fine-tuning stroke risk in AF patients with a moderate risk for stroke is feasible. Follow-up data will address the safety of this TEE-based approach.

Statins Do Not Reduce Atrial Fibrillation After Cardiac Valvular Surgery: A Single Centre Observational Study.

INTRODUCTION: Statins may theoretically reduce postoperative atrial fibrillation (AF) in patients after cardiac valvular surgery due to preservation of endothelial function and anti-ischaemic, anti-inflammatory and anti-remodelling effects. METHODS: Two hundred seventy-two patients who underwent cardiac workup and subsequently cardiac valvular surgery without AF and concomitant coronary artery bypass grafting (CABG) at our hospital were selected. Preoperative drug use and postoperative AF were recorded. AF was defined as any episode of AF longer than 10 s. In addition, results from echocardiography and blood samples were retrieved. RESULTS: BASELINE CHARACTERISTICS WERE AS FOLLOWS: mean age was 65 ± 11 years, 142 (52%) patients were male, 189 (70%) had undergone aortic valve surgery and the mean left ventricular ejection fraction was 57 ± 12%. Statins were used by 79 patients (29%). Statin users, more often, had a prior percutaneous coronary intervention (25% vs 9%, p < 0.001) or CABG (24% vs 4%, p < 0.001), diabetes mellitus (22% vs 5%, p < 0.001) and more often used ß-blockers (51% vs 24%, p < 0.001). Patients in the non-statin group more often had surgery on more than one valve (10% vs 3%, p = 0.043) and had a higher cholesterol level (222 ± 48 vs 190 ± 43 mg/dl, p < 0.001). Postoperative AF occurred in 54% (43/79) of the patients with and in 55% (106/193) of the patients without statins (p = 0.941). There was also no difference in the timing of onset of AF or duration of hospital stay. CONCLUSION: In this observational study, statin use was not associated with a reduced incidence of AF in patients after cardiac valvular surgery.

Improving guideline adherence in the treatment of atrial fibrillation by implementing an integrated chronic care program.

Background / Objectives. Atrial fibrillation (AF) is a very frequent and complex disease often associated with other medical conditions. The Euro Heart Survey (EHS) on AF showed that adherence to guidelines may reduce morbidity and mortality in AF patients. Therefore a nurse-driven, guideline-based, ICT-supported integrated chronic care program (ICCP) was developed and implemented in daily practice. The objective of this study is to evaluate the clinical feasibility of the ICCP, with guideline adherence as the endpoint.Methods. 111 ambulant patients referred for treatment of their AF were enrolled in the ICCP. In this group, patients underwent standardised clinical testing and were subsequently managed by a nurse, supported by a dedicated ICT program and supervised by cardiologists. For comparison, we used a recent historical control group of 102 patients who participated in the Maastricht part of the Euro Heart Survey (EHS) on AF. Results. Guideline adherence was excellent within the ICCP and compared favourably with the EHS-AF data concerning both clinical testing (trigger factors recorded in 100 vs. 44%; echocardiogram performed in 99 vs. 88%; thyroid-stimulating hormone level recorded in 96% vs. 63%) as well as treatment (antithrombotic therapy in 90 vs. 78%; rhythm control avoided in completely asymptomatic patients in 100 vs. 54%; class I drugs avoided in patients with structural heart disease in 90 vs. 95%; rhythm control avoided in permanent AF patients in 100 vs. 92%). Conclusion. The high level of guideline adherence suggests that a nurse-driven, guideline-based, ICT-supported ICCP for AF patients is feasible. (Neth Heart J 2010;18:471-7.).

No effect of rosuvastatin on left ventricular hypertrophy in patients with hypertension: a prospective randomised open-label study with blinded endpoint assessment.

BACKGROUND: This study tested the hypothesis that statins may reduce left ventricular hypertrophy (LVH) in patients with hypertension and LVH. METHOD: A prospective randomised open-label study with blinded endpoints assessment was performed in 142 patients. Inclusion criteria were hypertension, left ventricular ejection fraction ≥50% and echocardiographic determined LVH, defined as a left ventricular mass index (LVMI) of ≥ 100 g/m(2) in women and ≥ 116 g/m(2) in males. Patients were randomised between rosuvastatin 20mg once daily vs control. For each patient an echocardiogram and blood samples were obtained. These tests were repeated after 6 months. RESULTS: Baseline characteristics: mean age was 62 ± 11year and 62 (44%) were male. In both groups, there was a non-significant reduction in LVMI: 118 ± 22 to 111 ± 19 g/m(2) in the control group and 118 ± 21 to 114 ± 22 in the rosuvastatin group (p=0.376 for the comparison between rosuvastatin and control after 6 months). After six months, LDL-cholesterol was reduced from 3.5 ± 1.0 to 2.1 ± 1.2 mmol/L (40% reduction) in the rosuvastatin group and remained unchanged in the control group (3.5 ± 0.9 vs 3.6 ± 0.9 mmol/L. Hs-CRP decreased more with rosuvastatin compared to control (-38% vs -15%, p=0.006) There was no significant reduction in NT-pro-BNP levels after 6 months. CONCLUSION: Rosuvastatin does not reduce LVH despite a large LDL reduction in patients with hypertension and LVH.