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1.
Cardiovasc Diabetol ; 19(1): 42, 2020 Mar 31.
Artigo em Inglês | MEDLINE | ID: mdl-32234045

RESUMO

BACKGROUND: Stress cardiovascular magnetic resonance (CMR) to screen for silent myocardial ischaemia in asymptomatic high risk patients with type 2 diabetes mellitus (DM) has never been performed, and its effectiveness is unknown. Our aim was to determine the feasibility of a screening programme using stress CMR by obtaining preliminary data on the prevalence of silent ischaemia caused by obstructive coronary artery disease (CAD) and quantify myocardial perfusion in asymptomatic high risk patients with type 2 diabetes. METHODS: In this prospective cohort study, we recruited 63 asymptomatic DM patients (mean age 66 years ± 4.4 years; 77.8% male); with Framingham risk score ≥ 20% from 3 sites from June 2017 to August 2018. Normal volunteers were recruited to determine normal global myocardial perfusion reserve index (MPRI). Adenosine stress CMR and global MPRI was performed and measured in all subjects. Positive stress CMR cases were referred for catheter coronary angiography (CCA) with/without fractional flow reserve (FFR) measurements. Positive CCA was defined as an FFR ≤ 0.8 or coronary narrowing ≥ 70%. Patients were followed up for major adverse cardiovascular events. Prevalence is presented as patient numbers and percentage. Mann-Whitney U test was used to compare global MPRI between patients and normal volunteers. RESULTS: 13 patients had positive stress CMR with positive CCA (20.6% of patient population), while 9 patients with positive stress CMR examinations had a negative CCA. 5 patients (7.9%) had infarcts detected of which 2 patients had no stress perfusion defects. 12 patients had coronary artery stents inserted, whilst 1 patient declined stent placement. DM patients had lower global MPRI than normal volunteers (n = 7) (1.43 ± 0.27 vs 1.83 ± 0.31 respectively; p < 0.01). After a median follow-up of 653 days, there was no death, heart failure, acute coronary syndrome hospitalisation or stroke. CONCLUSION: 20.6% of asymptomatic DM patients (with Framingham risk ≥ 20%) had silent obstructive CAD. Furthermore, asymptomatic patients have reduced global MPRI than normal volunteers. TRIAL REGISTRATION: ClinicalTrials.gov Registration Number: NCT03263728 on 28th August 2017; https://clinicaltrials.gov/ct2/show/NCT03263728.

2.
Artigo em Inglês | MEDLINE | ID: mdl-32236828

RESUMO

PURPOSE: Little data exist for comparing cardiac safety and survival outcomes of trastuzumab/pertuzumab or ado-T emtansine (TDM1) in metastatic breast cancer (MBC) patients enrolled in randomized clinical trial (RCT) vs the real-world. METHODS: This was a retrospective population-based cohort of all patients with MBC treated with trastuzumab/pertuzumab or TDM1 (2012-2017) in Ontario, Canada. Outcomes were incident heart failure (HF) and overall survival (OS). RCT data were obtained from digitizing survival curves and compared with cohort data using Kaplan-Meier analysis. Age-based comparison of outcomes was conducted for patients ≥ 65 years old vs younger than 65. RESULTS: The two cohorts composed of 833 and 397 patients treated with trastuzumab/pertuzumab and TDM1, of whom 5.5% and 7.6% had baseline HF, respectively. Incident HF following trastuzumab/pertuzumab or TDM1 was low (trastuzumab/pertuzumab 1.8 events/100 person years; TDM1 0.02 events/100 person years). The median OS was 39.2 and 56.4 months in the trastuzumab/pertuzumab population-based cohort and CLEOPATRA, respectively. The median OS was 15.4 and 30.9 months in the TDM1 population-based cohort and EMILIA, respectively. Cohort OS was significantly worse than RCT OS (trastuzumab/pertuzumab HR 1.67, 95% CI 1.37-2.03, p < 0.0001; TDM1 HR 2.80, 95% CI 2.27-3.44, p < 0.0001). Older patients had worse OS than younger patients for trastuzumab/pertuzumab (HR 1.60, 95% CI 1.19-2.16, p = 0.0018), but not for TDM1 (HR 1.16, 95% CI 0.81-1.66, p = 0.43). CONCLUSION: HF incidence during trastuzumab/pertuzumab or TDM1 therapy in this real-world cohort was low. Survival in this cohort was worse compared to RCT, suggesting that recruitment of patients similar to the real-world population is required.

8.
J Nephrol ; 2019 Nov 14.
Artigo em Inglês | MEDLINE | ID: mdl-31728837

RESUMO

BACKGROUND: Conversion from conventional hemodialysis (CHD) to in-centre nocturnal hemodialysis (INHD) is associated with left ventricular (LV) mass regression, but the underlying mechanisms are not fully understood. Using cardiac MRI (CMR), we examined the effects of INHD on epicardial adipose tissue (EAT) and paracardial adipose tissue (PAT), and the relationships between EAT, PAT and LV remodeling, biomarkers of nutrition, myocardial injury, fibrosis and volume. METHODS: We conducted a prospective multicenter cohort study of 37 patients transitioned from CHD to INHD and 30 patients on CHD (control). Biochemical markers and CMR were performed at baseline and 52 weeks. CMR images were analyzed by independent readers, blinded to order and treatment group. RESULTS: Among 64 participants with complete CMR studies at baseline (mean age 54; 43% women), there were no significant differences in EAT index (60.6 ± 4.3 mL/m2 vs 64.2 ± 5.1 mL/m2, p = 0.99) or PAT index (60.0 ± 5.4 mL/m2 vs 53.2 ± 5.9 mL/m2, p = 0.42) between INHD and CHD groups. Over 52 weeks, EAT index and PAT index did not change significantly in INHD and CHD groups (p = 0.21 and 0.14, respectively), and the changes in EAT index and PAT index did not differ significantly between INHD and CHD groups (p = 0.30 and 0.16, respectively). Overall, changes in EAT index inversely correlated with changes in LV end-systolic volume index (LVESVI) but not LV end-diastolic volume index (LVEDVI), LV mass index (LVMI), and LV ejection fraction (LVEF). Changes in PAT index inversely correlated with changes in LVESVI, LVMI and positively correlated with changes in LVEF. There were no correlations between changes in EAT index or PAT index with changes in albumin, LDL, triglycerides, troponin-I, FGF-23, or NT-proBNP levels over 52 weeks (all p > 0.30). CONCLUSIONS: INHD was not associated with any changes in EAT index and PAT index over 12 months. Changes in EAT index were not significantly associated with changes in markers of LV remodeling, nutrition, myocardial injury, fibrosis, volume status. In contrast, changes in PAT index, which paradoxically is expected to exert less paracrine effect on the myocardium, were correlated with changes in LVESVI, LVMI and LVEF. Larger and longer-term studies may clarify the role of PAT in cardiac remodeling with intensified hemodialysis. CLINICALTRIALS. GOV IDENTIFIER: NCT00718848.

9.
Circ Cardiovasc Imaging ; 12(11): e009156, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31735067

RESUMO

BACKGROUND: In ischemic cardiomyopathy, cardiac magnetic resonance assessment of the peri-infarct zone, a potential substrate for arrhythmogenesis, may serve as a novel prognosticator and guide the optimal use of implantable cardioverter-defibrillators. We undertook a systematic review and meta-analysis assessing the prognostic value of the peri-infarct zone on late gadolinium enhancement cardiac magnetic resonance in ischemic cardiomyopathy. METHODS: We searched MEDLINE (Medical Literature Analysis and Retrieval System Online), EMBASE (Medical Literature Analysis and Retrieval System Online), and CENTRAL (Medical Literature Analysis and Retrieval System Online) from inception to January 2019 for prognostic studies relating peri-infarct size with clinical outcomes in ischemic cardiomyopathy. Two authors independently performed study selection and data extraction. Pooled effect estimates were calculated with random effects models, risk of bias and strength of evidence were assessed by the Quality in Prognostic Studies tool and Grading of Recommendations Assessment, Development, and Education, respectively. RESULTS: Twenty studies were eligible, representing 14 cohort studies (n=1518) with mean follow-up of 3.6 years and 6 cross-sectional studies (n=189). The extent of the peri-infarct zone was significantly predictive of all-cause mortality (3 studies; n=539; hazard ratio, 1.34/10 g [95% CI, 1.13-1.59]; I2=0%; high-quality evidence), appropriate implantable cardioverter-defibrillator therapy (5 studies; n=361; hazard ratio, 1.31/10 g [95% CI, 1.17-1.47]; I2=0%; high-quality evidence), and inducibility of ventricular tachycardia on electrophysiological study (5 studies; n=167; OR, 2.63/g [95% CI, 1.39-4.96]; I2=14%; low-quality evidence). After adjusting for age and left ventricular ejection fraction, the peri-infarct zone, as a percentage of total infarct size, remained an independent predictor of all-cause mortality (2 studies; n=445; hazard ratio, 1.29/10% [95% CI, 1.15-1.44]; I2=0%; high-quality evidence). CONCLUSIONS: There is limited but consistent evidence that quantification of the peri-infarct zone predicts long-term mortality and appropriate implantable cardioverter-defibrillator therapy in ischemic cardiomyopathy. Future studies should confirm whether late gadolinium enhancement-cardiac magnetic resonance assessment may improve implantable cardioverter-defibrillator treatment decisions. CLINICAL TRIAL REGISTRATION: URL: https://www.crd.york.ac.uk/prospero/. Unique identifier: CRD42017077337.

11.
Am J Clin Nutr ; 110(6): 1287-1295, 2019 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-31504093

RESUMO

BACKGROUND: Thiamin, a water-soluble B-complex vitamin, functions as a coenzyme in macronutrient oxidation and in the production of cellular ATP. Data suggest that thiamin depletion occurs in heart failure (HF). Therefore, thiamin supplementation in HF patients may improve cardiac function. OBJECTIVE: We sought to determine whether oral thiamin supplementation improves left ventricular ejection fraction (LVEF), exercise tolerance, and quality of life among patients with HF and reduced LVEF. METHODS: In this prospective, multicenter, double-blind, placebo-controlled randomized trial, eligible ambulatory patients with HF and reduced LVEF were recruited from 4 academic and community hospitals between 2010 and 2015. Participants were randomly assigned to receive either 200 mg oral thiamin mononitrate per day or placebo for 6 mo. RESULTS: Sixty-nine patients (mean ± SD age: 64 ± 12 y; 83% men; LVEF: 37% ± 11%) were randomly assigned: 34 received placebo and 35 received thiamin supplementation. Erythrocyte thiamin pyrophosphate and urine thiamin concentrations were significantly higher in the supplemented group than in the placebo group at 6 mo (P = 0.02 and <0.001, respectively). At 6 mo, LVEF was significantly higher in the placebo group than in the thiamin group (38%; 95% CI: 36%, 39% compared with 35%; 95% CI: 33%, 37%, P = 0.047) after adjusting for baseline measurements. There were no significant differences in Minnesota Living with Heart Failure score, distance walked in 6 min, and N-terminal prohormone of brain natriuretic peptide concentrations between the 2 groups. One patient (2.9%) in the thiamin-supplemented group and none in the control group died at 6 mo. CONCLUSIONS: In ambulatory patients with HF and reduced LVEF, thiamin supplementation for 6 mo did not improve LVEF, quality of life, or exercise capacity, despite increases in thiamin concentrations. These findings do not support routine thiamin supplementation in the treatment of HF and reduced LVEF.This trial was registered at clinicaltrials.gov as NCT00959075.

12.
Cell Metab ; 30(4): 609-613, 2019 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-31477497

RESUMO

Hess et al. quantified circulating aldehyde dehydrogenase-expressing (ALDHhi) cell subsets in people with T2DM given either empagliflozin (EMPA) or placebo. EMPA treatment increased circulating pro-angiogenic CD133+ progenitor cells, decreased pro-inflammatory ALDHhi granulocyte precursors, and increased ALDHhi monocytes with M2 polarization. EMPA treatment improved T2DM-associated "regenerative cell depletion" contributing to enhanced vascular health.

13.
BMJ Open ; 9(9): e032165, 2019 Sep 05.
Artigo em Inglês | MEDLINE | ID: mdl-31492797

RESUMO

INTRODUCTION: For non-ST-segment elevation acute coronary syndrome (NSTEACS) there is a gap between the use of class I guideline recommended therapies and clinical practice. The Global Registry of Acute Coronary Events (GRACE) risk score is recommended in international guidelines for the risk stratification of NSTEACS, but its impact on adherence to guideline-indicated treatments and reducing adverse clinical outcomes is unknown. The objective of the UK GRACE Risk Score Intervention Study (UKGRIS) trial is to assess the effectiveness of the GRACE risk score tool and associated treatment recommendations on the use of guideline-indicated care and clinical outcomes. METHODS AND ANALYSIS: The UKGRIS, a parallel-group cluster randomised registry-based controlled trial, will allocate hospitals in a 1:1 ratio to manage NSTEACS by standard care or according to the GRACE risk score and associated international guidelines. UKGRIS will recruit a minimum of 3000 patients from at least 30 English National Health Service hospitals and collect healthcare data from national electronic health records. The co-primary endpoints are the use of guideline-indicated therapies, and the composite of cardiovascular death, non-fatal myocardial infarction, new onset heart failure hospitalisation or cardiovascular readmission at 12 months. Secondary endpoints include duration of inpatient hospital stay over 12 months, EQ-5D-5L responses and utilities, unscheduled revascularisation and the components of the composite endpoint over 12 months follow-up. ETHICS AND DISSEMINATION: The study has ethical approval (North East - Tyne & Wear South Research Ethics Committee reference: 14/NE/1180). Findings will be announced at relevant conferences and published in peer-reviewed journals in line with the funder's open access policy. TRIAL REGISTRATION NUMBER: ISRCTN29731761; Pre-results.

14.
Circulation ; 140(21): 1693-1702, 2019 Nov 19.
Artigo em Inglês | MEDLINE | ID: mdl-31434508

RESUMO

BACKGROUND: SGLT2 (sodium-glucose cotransporter 2) inhibitors lower cardiovascular events in type 2 diabetes mellitus but whether they promote direct cardiac effects remains unknown. We sought to determine if empagliflozin causes a decrease in left ventricular (LV) mass in people with type 2 diabetes mellitus and coronary artery disease. METHODS: Between November 2016 and April 2018, we recruited 97 individuals ≥40 and ≤80 years old with glycated hemoglobin 6.5% to 10.0%, known coronary artery disease, and estimated glomerular filtration rate ≥60mL/min/1.73m2. The participants were randomized to empagliflozin (10 mg/day, n=49) or placebo (n=48) for 6 months, in addition to standard of care. The primary outcome was the 6-month change in LV mass indexed to body surface area from baseline as measured by cardiac magnetic resonance imaging. Other measures included 6-month changes in LV end-diastolic and -systolic volumes indexed to body surface area, ejection fraction, 24-hour ambulatory blood pressure, hematocrit, and NT-proBNP (N-terminal pro b-type natriuretic peptide). RESULTS: Among the 97 participants (90 men [93%], mean [standard deviation] age 62.8 [9.0] years, type 2 diabetes mellitus duration 11.0 [8.2] years, estimated glomerular filtration rate 88.4 [16.9] mL/min/1.73m2, LV mass indexed to body surface area 60.7 [11.9] g/m2), 90 had evaluable imaging at follow-up. Mean LV mass indexed to body surface area regression over 6 months was 2.6 g/m2 and 0.01 g/m2 for those assigned empagliflozin and placebo, respectively (adjusted difference -3.35 g/m2; 95% CI, -5.9 to -0.81g/m2, P=0.01). In the empagliflozin-allocated group, there was significant lowering of overall ambulatory systolic blood pressure (adjusted difference -6.8mmHg, 95% CI -11.2 to -2.3mmHg, P=0.003), diastolic blood pressure (adjusted difference -3.2mmHg; 95% CI, -5.8 to -0.6mmHg, P=0.02) and elevation of hematocrit (P=0.0003). CONCLUSIONS: Among people with type 2 diabetes mellitus and coronary artery disease, SGLT2 inhibition with empagliflozin was associated with significant reduction in LV mass indexed to body surface area after 6 months, which may account in part for the beneficial cardiovascular outcomes observed in the EMPA-REG OUTCOME (BI 10773 [Empagliflozin] Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients) trial. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02998970.

15.
Clin Biochem ; 73: 57-61, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31361994

RESUMO

BACKGROUND: Growth differentiation factor 15 (GDF15) is markedly increased in end-stage kidney disease and has been related to increased mortality in patients on dialysis. We hypothesized that kidney transplantation would decrease both GDF15 and N-terminal pro-B-type natriuretic peptide (NT-proBNP) and that GDF-15 decrease relates to post-kidney transplantation allograft function. METHODS: End-stage kidney disease patients on dialysis awaiting a living donor kidney transplantation (n = 39), and those expected to be on the deceased donor waitlist for at least 12 months (n = 43) were enrolled at three transplant centers. Serum GDF15 and NT-proBNP were measured at 0, 3, and 12 months post-kidney transplantation or post-enrollment. Change in serum GDF15 and NT-proBNP concentrations, and their relation to estimated glomerular filtration rate (eGFR) were assessed by non-parametric tests and regression analyses. RESULTS: Median baseline GDF15 was 4744 pg/ml and 5451 pg/ml for the kidney transplantation and dialysis groups, respectively (p = 0.09). Kidney transplantation resulted in a significant decrease in GDF15 (month 12 median 1631 pg/ml, p < 0.0001 vs. baseline), whereas there was no change for the dialysis group (month 12 median 5658 pg/ml, p = 0.31). Post-kidney transplantation NT-proBNP highly correlated with GDF15 (ρ = 0.64, p < 0.0001). GDF15 inversely correlated with post-transplant eGFR for the kidney transplantation group (ρ = -0.42, p = 0.0081). Month 12 NT-proBNP explained 15.8% and 40.1% of the variance in month 12 GDF15 in the dialysis and kidney transplantation groups, respectively. The relationship of GDF15 with eGFR was no longer significant when NT-proBNP was included in the models. CONCLUSIONS: Kidney transplantation significantly decreases serum GDF15 concentrations. The post-kidney transplantation association of GDF15 with NT-proBNP is consistent with a gradient of post- kidney transplantation cardiovascular risk.


Assuntos
Fator 15 de Diferenciação de Crescimento/sangue , Transplante de Rim , Peptídeo Natriurético Encefálico/sangue , Fragmentos de Peptídeos/sangue , Adulto , Aloenxertos , Doenças Cardiovasculares/sangue , Doenças Cardiovasculares/etiologia , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Fatores de Risco
17.
Int J Cardiovasc Imaging ; 35(11): 2085-2093, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31197526

RESUMO

Little is known about the comparison of multiple-gated acquisition (MUGA) scanning with cardiovascular magnetic resonance (CMR) for serial monitoring of HER2+ breast cancer patients receiving trastuzumab. The association of cardiac biomarkers with CMR left ventricular (LV) function and volume is also not well studied. Our objectives were to compare CMR and MUGA for left ventricular ejection fraction (LVEF) assessment, and to examine the association between changes in brain natriuretic peptide (NT-BNP) and troponin-I and changes in CMR LV function and volume. This prospective longitudinal two-centre cohort study recruited HER2+ breast cancer patients between January 2010 and December 2013. MUGA, CMR, NT-BNP and troponin-I were performed at baseline, 6, 12, and 18 months after trastuzumab initiation. In total, 41 patients (age 51.7 ± 10.8 years) were enrolled. LVEF comparison between MUGA and CMR demonstrated weak agreement (Lin's correlation coefficient r = 0.46, baseline; r = 0.29, 6 months; r = 0.42, 12 months; r = 0.39, 18 months; all p < 0.05). Bland-Altman plots demonstrated wide LVEF agreement limits (pooled agreement limits 3.0 ± 6.2). Both modalities demonstrated significant LVEF decline at 6 and 12 months from baseline, concomitant with increased LV volumes on CMR. Changes in NT-BNP correlated with changes in LV diastolic volume at 12 and 18 months (p < 0.05), and LV systolic volume at 18 months (p < 0.05). Changes in troponin-I did not correlate with changes in LV function or volume at any timepoint. In conclusion, CMR and MUGA LVEF are not interchangeable, warranting selection and utility of one modality for serial monitoring. CMR is useful due to less radiation exposure and accuracy of LV volume measurements. Changes in NT-BNP correlated with changes in LV volumes.


Assuntos
Antineoplásicos Imunológicos/efeitos adversos , Neoplasias da Mama/tratamento farmacológico , Imagem por Ressonância Magnética , Compostos Radiofarmacêuticos/administração & dosagem , Pertecnetato Tc 99m de Sódio/administração & dosagem , Volume Sistólico/efeitos dos fármacos , Tomografia Computadorizada de Emissão , Trastuzumab/efeitos adversos , Disfunção Ventricular Esquerda/diagnóstico por imagem , Função Ventricular Esquerda/efeitos dos fármacos , Adulto , Biomarcadores/sangue , Técnicas de Imagem de Sincronização Cardíaca , Cardiotoxicidade , Feminino , Humanos , Pessoa de Meia-Idade , Peptídeo Natriurético Encefálico/sangue , Fragmentos de Peptídeos/sangue , Valor Preditivo dos Testes , Estudos Prospectivos , Reprodutibilidade dos Testes , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Troponina I/sangue , Disfunção Ventricular Esquerda/induzido quimicamente , Disfunção Ventricular Esquerda/fisiopatologia
18.
Heart ; 105(21): 1649-1655, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31129611

RESUMO

OBJECTIVE: We examined use of ECG monitoring in oncology patients prescribed QT-prolonging drugs. METHODS: Patients ≥66 years diagnosed with cancer between 2005 and 2011 were identified through the Ontario Cancer Registry and linked to multiple population-based administrative databases to ascertain demographics, comorbidities, prescription drug use, systemic therapy and ECG. QT-prolonging drugs were identified as per drug lists developed by the Arizona Center for Education and Research on Therapeutics. Univariable and multivariable analyses were used to examine factors associated with ECG use in patients on first-line systemic therapy. RESULTS: A total of 48 236 patients (median age 74; 49% women) received one or more drugs associated with a risk of QT-interval prolongation but only 27% of patients had an ECG performed. Factors associated with more ECG use on multivariable analysis included recent cancer diagnosis (p for trend <0.001 between 2005 and 2011), use of concurrent QT-prolonging drugs (OR=1.15 per each additional QT-prolonging drug, 95% CI 1.12 to 1.17) and the presence of coronary artery disease (OR 1.31; 95% CI 1.25 to 1.38) and heart failure (OR 1.25; 95% CI 1.17 to 1.35). Use of anticancer (OR 0.74; 95% CI 0.70 to 0.79) and antiemetic (OR 0.93; 95% CI 0.88 to 0.99) QT-prolonging drugs was paradoxically associated with less ECG use. CONCLUSIONS: Our study highlights common use of QT-prolonging drugs and underuse of ECG in oncology patients. Since ECG is an inexpensive, non-invasive and widely available test, it may be readily incorporated in the monitoring of patients for toxicities in routine clinical practice.

19.
Can J Cardiol ; 35(5): 653-660, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-31030866

RESUMO

BACKGROUND: Although it is known that women do not participate in trials as frequently as men, there are limited recent data examining how women recruitment has changed over time. METHODS: We conducted MEDLINE search using a validated strategy for randomized trials published in New England Journal of Medicine, Lancet, and Journal of the American Medical Association between 1986 and 2015, and included trials evaluating pharmacologic or nonpharmacologic therapies. We abstracted data on demographics, intervention type, clinical indication, and trial design characteristics, and examined their relationships with women enrollment. RESULTS: In total, 598 trials met inclusion criteria. Women enrollment increased significantly over time (21% between 1986 and 1990 to 33% between 2011 and 2015; Pfor trend < 0.001) and did not differ by journal or funding source. Women enrollment varied with clinical indication, comprising 37% for non-coronary artery disease vascular trials, 30% for coronary artery disease trials, 28% for heart failure trials, and 28% for arrhythmia trials (P < 0.001), which were all significantly lower than the expected proportion in disease populations (P < 0.001). Women enrollment varied with trial type (31%, 29%, and 26% for pharmacologic, device, and procedural trials, respectively; P = 0.001). These findings were corroborated using multivariable analysis. We found significant positive correlations between women enrolled, and mean age and total number of participants. Fewer women were enrolled in trials reporting statistically significant results than those who did not (P = 0.001). CONCLUSIONS: Although enrollment of women has increased over time, it remains lower than the relative proportion in the disease population. Future studies should elucidate the reasons for persistent under-representation of women in clinical trials.


Assuntos
Seleção de Pacientes , Ensaios Clínicos Controlados Aleatórios como Assunto , Sujeitos da Pesquisa/estatística & dados numéricos , Saúde da Mulher , Doenças Cardiovasculares , Feminino , Humanos
20.
J Acad Nutr Diet ; 119(7): 1160-1167, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-30928321

RESUMO

BACKGROUND: Thiamin is a required coenzyme in energy production reactions that fuel myocardial contraction. Therefore, thiamin deficiency (TD) may aggravate cardiac dysfunction in patients with systolic heart failure (HF). OBJECTIVE: To determine the prevalence of TD in ambulatory participants with HF as well as the relationships between thiamin status and HF severity, dietary thiamin intake, diuretic use, and circulating neurohormones. DESIGN: A cross-sectional study comparing the prevalence of TD in ambulatory patients with HF with that of controls. Demographic, anthropometric, nutrition, medication use, and heart function data were collected from direct interviewing, questionnaires, and medical records. Blood samples were obtained to measure levels of neurohormones and assess TD. PARTICIPANTS/SETTING: Fifty age-matched control participants without HF and 100 outpatients with HF and reduced left ventricular function were recruited from clinics at St Michael's Hospital, University Health Network and Mount Sinai Hospital, Toronto, Ontario, Canada, between September 2009 and February 2011. MAIN OUTCOME MEASURES: To assess TD, erythrocyte thiamin pyrophosphate (TPP) was measured using high-performance liquid chromatography. TD was defined as TPP<6.07 µg/dL (180 nmol/L). STATISTICAL ANALYSES PERFORMED: Prevalence rates were analyzed using χ2 test. Nonparametric statistics (Jonckheere-Terpstra, Kruskal-Wallis, Spearman's correlation) were used to assess TPP levels in relation to HF severity, medication use and plasma concentrations of F2-isoprostanes, norepinephrine, and N-terminal pro-brain natriuretic peptide (NT-proBNP). RESULTS: There was no significant difference in the prevalence of TD in outpatients with HF (6%) and controls (6%) (P=0.99). No relationship was found between heart function, thiamin intake, use or dose of diuretics, and TD. A positive relationship was observed between erythrocyte TPP and F2-isoprostane levels (rs=0.22, P=0.03) but not between erythrocyte TPP and norepinephrine (P=0.45) and NT-proBNP (P=0.58). CONCLUSION: The prevalence of TD was low in ambulatory HF participants suggesting that, unlike hospitalized patients, ambulatory patients may be at a low risk for TD.

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