4,342 research outputs found

    Effects of vildagliptin on ventricular function in patients with type 2 diabetes mellitus and heart failure: a randomized placebo-controlled trial

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    Objectives: This study sought to examine the safety of the dipeptidyl peptidase-4 inhibitor, vildagliptin, in patients with heart failure and reduced ejection fraction. Background: Many patients with type 2 diabetes mellitus have heart failure and it is important to know about the safety of new treatments for diabetes in these individuals. Methods: Patients 18 to 85 years of age with type 2 diabetes and heart failure (New York Heart Association functional class I to III and left ventricular ejection fraction [LVEF] <0.40) were randomized to 52 weeks treatment with vildagliptin 50 mg twice daily (50 mg once daily if treated with a sulfonylurea) or matching placebo. The primary endpoint was between-treatment change from baseline in echocardiographic LVEF using a noninferiority margin of −3.5%. Results: A total of 254 patients were randomly assigned to vildagliptin (n = 128) or placebo (n = 126). Baseline LVEF was 30.6 ± 6.8% in the vildagliptin group and 29.6 ± 7.7% in the placebo group. The adjusted mean change in LVEF was 4.95 ± 1.25% in vildagliptin treated patients and 4.33 ± 1.23% in placebo treated patients, a difference of 0.62 (95% confidence interval [CI]: −2.21 to 3.44; p = 0.667). This difference met the predefined noninferiority margin of −3.5%. Left ventricular end-diastolic and end-systolic volumes increased more in the vildagliptin group by 17.1 ml (95% CI: 4.6 to 29.5 ml; p = 0.007) and 9.4 ml (95% CI: −0.49 to 19.4 ml; p = 0.062), respectively. Decrease in hemoglobin A1c from baseline to 16 weeks, the main secondary endpoint, was greater in the vildagliptin group: −0.62% (95% CI: −0.93 to −0.30%; p < 0.001; −6.8 mmol/mol; 95% CI: −10.2 to −3.3 mmol/mol). Conclusions: Compared with placebo, vildagliptin had no major effect on LVEF but did lead to an increase in left ventricular volumes, the cause and clinical significance of which is unknown. More evidence is needed regarding the safety of dipeptidyl peptidase-4 inhibitors in patients with heart failure and left ventricular systolic dysfunction. (Effect of Vildagliptin on Left Ventricular Function in Patients With Type 2 Diabetes and Congestive Heart Failure; NCT00894868

    Beneficial effects of long-term intravenous iron therapy with ferric carboxymaltose in patients with symptomatic heart failure and iron deficiency

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    AIM: The aim of this study was to evaluate the benefits and safety of long-term i.v. iron therapy in iron-deficient patients with heart failure (HF). METHODS AND RESULTS: CONFIRM-HF was a multi-centre, double-blind, placebo-controlled trial that enrolled 304 ambulatory symptomatic HF patients with left ventricular ejection fraction </=45%, elevated natriuretic peptides, and iron deficiency (ferritin <100 ng/mL or 100-300 ng/mL if transferrin saturation <20%). Patients were randomized 1 : 1 to treatment with i.v. iron, as ferric carboxymaltose (FCM, n = 152) or placebo (saline, n = 152) for 52 weeks. The primary end-point was the change in 6-min-walk-test (6MWT) distance from baseline to Week 24. Secondary end-points included changes in New York Heart Association (NYHA) class, Patient Global Assessment (PGA), 6MWT distance, health-related quality of life (QoL), Fatigue Score at Weeks 6, 12, 24, 36, and 52 and the effect of FCM on the rate of hospitalization for worsening HF. Treatment with FCM significantly prolonged 6MWT distance at Week 24 (difference FCM vs. placebo: 33 +/- 11 m, P = 0.002). The treatment effect of FCM was consistent in all subgroups and was sustained to Week 52 (difference FCM vs. placebo: 36 +/- 11 m, P < 0.001). Throughout the study, an improvement in NYHA class, PGA, QoL, and Fatigue Score in patients treated with FCM was detected with statistical significance observed from Week 24 onwards. Treatment with FCM was associated with a significant reduction in the risk of hospitalizations for worsening HF [hazard ratio (95% confidence interval): 0.39 (0.19-0.82), P = 0.009]. The number of deaths (FCM: 12, placebo: 14 deaths) and the incidence of adverse events were comparable between both groups. CONCLUSION: Treatment of symptomatic, iron-deficient HF patients with FCM over a 1-year period resulted in sustainable improvement in functional capacity, symptoms, and QoL and may be associated with risk reduction of hospitalization for worsening HF (ClinicalTrials.gov number NCT01453608

    Cardioversion differences among first detected episode, paroxysmal, and persistent atrial fibrillation patients in the RHYTHM AF registry in Poland

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    Background: The aim of the publication is to show differences among patients with the first detected episode of atrial fibrillation (AF), paroxysmal, and persistent AF patients, for whom cardioversion was planned in the hospital setting in Poland. Methods: We present an analysis of the Polish cohort of the multicenter, multinational RHYTHM-AF registry. Consecutive patients in the hospital setting, aged ≥ 18 years, with documented AF at the time of enrollment, and for whom cardioversion of AF is one of the planned therapeutic options were recruited. Follow-up data was collected 60 days after enrollment. Results: Five-hundred-and-one patients were recruited, 483 with a defined AF type: 88 — first detected, 191 paroxysmal, and 204 persistent AF. CHA2DS2VASc scores were not significantly different between the groups, while treatment with vitamin K antagonists (VKA) was significantly lower in paroxysmal AF group than in persistent AF patients. Primary electrical cardioversion was most commonly performed in patients with persistent AF (90.4%), while primary pharmacological cardioversion — in the first detected AF (80.0%) and paroxysmal AF patients (76.7%). During 2 months of follow-up, the rate of rehospitalization and complications was comparable among the groups. Conclusions: Despite their comparable CHA2DS2VASc scores, patients with persistent AF were more frequently treated with VKA antagonists than other groups. Recurrence of AF within 2 months after restoring sinus rhythm was present in about 25% of the patients, and the rate of complications was not different among the three groups.

    Cardioversion of Atrial Fibrillation (RHYTHM-AF) International Registry in Poland

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    Background: A key procedure of the rhythm control strategy in atrial fibrillation (AF) is cardioversion to normal sinus rhythm. The aim of the present study was to provide a review of treatment patterns for the cardioversion of patients with AF in a hospital setting in Poland and document the success rate of various cardioversion procedures.Methods: We herein present the results from Poland of a prospective observational study to characterize patients with recent onset episodes of AF for whom cardioversion is one of the planned therapeutic options — the RHYTHM-AF registry. Consecutive patients in the hospital setting, age &gt; 18 years, with documented AF at the time of enrollment, excluding those with atrial flutter and those treated with vernakalant, were recruited. No treatment was recommended nor discouraged.Results: Five hundred and one patients were recruited (mean age 64.2 ± 12.1), with 294 (58.7%) patients finally undergoing cardioversion. Primary electrical cardioversion (ECV) was successful in 131 (88.5%) patients. Primary pharmacological cardioversion (PCV) was successful in 110 (75.3%) patients. Amiodarone and propafenone were most commonly used (52.1% and 24.7%, respectively). Fourteen complications and adverse events were recorded (no stroke was observed).Conclusions: Conversion to sinus rhythm was attempted in &lt; 60% of the patients with AF admitted to the hospital with an intention to terminate arrhythmia. ECV was successful in ~90% of the patients, while PCV in ~75% of the patients (amiodarone and propafenone were most commonly used). The rate of complications was low (2.8%).

    Duration of chronic heart failure affects outcomes with preserved effects of heart rate reduction with ivabradine: findings from SHIFT

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    Aims: In heart failure (HF) with reduced ejection fraction and sinus rhythm, heart rate reduction with ivabradine reduces the composite incidence of cardiovascular death and HF hospitalization. Methods and results: It is unclear whether the duration of HF prior to therapy independently affects outcomes and whether it modifies the effect of heart rate reduction. In SHIFT, 6505 patients with chronic HF (left ventricular ejection fraction of ≤35%), in sinus rhythm, heart rate of ≥70 b.p.m., treated with guideline-recommended therapies, were randomized to placebo or ivabradine. Outcomes and the treatment effect of ivabradine in patients with different durations of HF were examined. Prior to randomization, 1416 ivabradine and 1459 placebo patients had HF duration of ≥4 weeks and &lt;1.5 years; 836 ivabradine and 806 placebo patients had HF duration of 1.5 years to &lt;4 years, and 989 ivabradine and 999 placebo patients had HF duration of ≥4 years. Patients with longer duration of HF were older (62.5 years vs. 59.0 years; P &lt; 0.0001), had more severe disease (New York Heart Association classes III/IV in 56% vs. 44.9%; P &lt; 0.0001) and greater incidences of co-morbidities [myocardial infarction: 62.9% vs. 49.4% (P &lt; 0.0001); renal dysfunction: 31.5% vs. 21.5% (P &lt; 0.0001); peripheral artery disease: 7.0% vs. 4.8% (P &lt; 0.0001)] compared with patients with a more recent diagnosis. After adjustments, longer HF duration was independently associated with poorer outcome. Effects of ivabradine were independent of HF duration. Conclusions: Duration of HF predicts outcome independently of risk indicators such as higher age, greater severity and more co-morbidities. Heart rate reduction with ivabradine improved outcomes independently of HF duration. Thus, HF treatments should be initiated early and it is important to characterize HF populations according to the chronicity of HF in future trials

    Implantable devices for heart failure monitoring: the CardioMEMSâ„¢ system.

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    Several devices have been developed for heart failure (HF) treatment and monitoring. Among device-based monitoring tools, CardioMEMSâ„¢ has received growing research attention. This document reflects the key points of an ESC consensus meeting on implantable devices for monitoring in HF, with a particular focus on CardioMEMSâ„¢

    Clinical profile and management of outpatients with non-ischemic and non-hypertensive systolic heart failure: Analysis of the Polish DATA-HELP registry

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    Background: Although coronary artery disease and arterial hypertension are the most common etiologies underlying heart failure (HF), there are still many patients present with non-ischemic and non-hypertensive HF whose management remains very challenging. In this research study the clinical profile and applied treatment of patients with HF without coronary artery disease or hypertension versus patients with known etiology of HF (ischemic/hypertensive) were compared. Methods: Clinical data about 5563 patients with stable systolic HF were obtained from prospective multicenter DATA-HELP registry performed between October and December 2009 in ambulatory clinics in Poland, in which 500 cardiologists and 290 general practitioners participated. Results: Heart failure of non-ischemic and non-hypertensive etiology which affected 10% of all patients and was particularly frequent in younger patients, both in women: &lt; 50 years old 42%; 50–65 years old 12%; &gt; 65 years old 7%; and men: &lt; 50 years old 47%; 50–65 years old 10%; &gt; 65 years old 5%; p &lt; 0.0001. Patients with non-ischemic and non-hypertensive HF were characterized by younger age, fewer co-morbidities, shorter duration of HF and, surprisingly, more advanced HF. Patients in this group were less likely to have received life-prolonging treatment in HF recommended by European Society of Cardiology (ESC) and more often required symptomatic management. Similarly, they were more likely to have implanted CRT-D and ICD. Conclusions: Heart failure of non-ischemic and non-hypertensive origin affects particularly young patients. These patients, despite suffering from more advanced HF are not optimally managed according to ESC guidelines
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