FELIX JOSE ALVAREZ RAMIRES

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Instituto do Coração, Hospital das Clínicas, Faculdade de Medicina - Médico
LIM/11 - Laboratório de Cirurgia Cardiovascular e Fisiopatologia da Circulação, Hospital das Clínicas, Faculdade de Medicina

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  • article 57 Citação(ões) na Scopus
    Contemporary Characteristics and Outcomes in Chagasic Heart Failure Compared With Other Nonischemic and Ischemic Cardiomyopathy
    (2017) SHEN, Li; RAMIRES, Felix; MARTINEZ, Felipe; BODANESE, Luiz Carlos; ECHEVERRIA, Luis Eduardo; GOMEZ, Efrain A.; ABRAHAM, William T.; DICKSTEIN, Kenneth; KOBER, Lars; PACKER, Milton; ROULEAU, Jean L.; SOLOMON, Scott D.; SWEDBERG, Karl; ZILE, Michael R.; JHUND, Pardeep S.; GIMPELEWICZ, Claudio R.; MCMURRAY, John J. V.
    BACKGROUND: Chagas' disease is an important cause of cardiomyopathy in Latin America. We aimed to compare clinical characteristics and outcomes in patients with heart failure (HF) with reduced ejection fraction caused by Chagas' disease, with other etiologies, in the era of modern HF therapies. METHODS AND RESULTS: This study included 2552 Latin American patients randomized in the PARADIGM-HF (Prospective Comparison of ARNI With ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure) and ATMOSPHERE (Aliskiren Trial to Minimize Outcomes in Patients With Heart Failure) trials. The investigator-reported etiology was categorized as Chagasic, other nonischemic, or ischemic cardiomyopathy. The outcomes of interest included the composite of cardiovascular death or HF hospitalization and its components and death from any cause. Unadjusted and adjusted Cox proportional hazards models were performed to compare outcomes by pathogenesis. There were 195 patients with Chagasic HF with reduced ejection fraction, 1300 with other nonischemic cardiomyopathy, and 1057 with ischemic cardiomyopathy. Compared with other etiologies, Chagasic patients were more often female, younger, and had lower prevalence of hypertension, diabetes mellitus, and renal impairment (but had higher prevalence of stroke and pacemaker implantation) and had worse health-related quality of life. The rates of the composite outcome were 17.2, 12.5, and 11.4 per 100 person-years for Chagasic, other nonischemic, and ischemic patients, respectively-adjusted hazard ratio for Chagasic versus other nonischemic: 1.49 (95% confidence interval, 1.15-1.94; P= 0.003) and Chagasic versus ischemic: 1.55 (1.18-2.04; P= 0.002). The rates of allcause mortality were also higher. CONCLUSIONS: Despite younger age, less comorbidity, and comprehensive use of conventional HF therapies, patients with Chagasic HF with reduced ejection fraction continue to have worse quality of life and higher hospitalization and mortality rates compared with other etiologies.
  • conferenceObject
    Effect of the angiotensin receptor neprilysin inhibitor LCZ696 compared with enalapril according to systolic blood pressure in PARADIGM-HF
    (2015) BOHM, M.; REFSGAARD, J.; RAMIRES, F. J. A.; ROULEAU, J. L.; SOLOMON, S. D.; SWEDBERG, K.; ZILE, M.; SHI, V. C.; PACKER, M.; MCMURRAY, J. J. V.
  • article 384 Citação(ões) na Scopus
    Cardiac Myosin Activation with Omecamtiv Mecarbil in Systolic Heart Failure
    (2021) TEERLINK, John R.; DIAZ, Rafael; FELKER, G. Michael; MCMURRAY, John J. V.; METRA, Marco; SOLOMON, Scott D.; ADAMS, Kirkwood F.; ANAND, Inder; ARIAS-MENDOZA, Alexandra; BIERING-SORENSEN, Tor; BOHM, Michael; BONDERMAN, Diana; CLELAND, John G. F.; CORBALAN, Ramon; CRESPO-LEIRO, Maria G.; DAHLSTROM, Ulf; ECHEVERRIA, Luis E.; FANG, James C.; FILIPPATOS, Gerasimos; FONSECA, Candida; GONCALVESOVA, Eva; GOUDEV, Assen R.; HOWLETT, Jonathan G.; LANFEAR, David E.; LI, Jing; LUND, Mayanna; MACDONALD, Peter; MAREEV, Viacheslav; MOMOMURA, Shin-ichi; O'MEARA, Eileen; PARKHOMENKO, Alexander; PONIKOWSKI, Piotr; RAMIRES, Felix J. A.; SERPYTIS, Pranas; SLIWA, Karen; SPINAR, Jindrich; SUTER, Thomas M.; TOMCSANYI, Janos; VANDEKERCKHOVE, Hans; VINEREANU, Dragos; VOORS, Adriaan A.; YILMAZ, Mehmet B.; ZANNAD, Faiez; SHARPSTEN, Lucie; LEGG, Jason C.; VARIN, Claire; HONARPOUR, Narimon; ABBASI, Siddique A.; MALIK, Fady I.; KURTZ, Christopher E.
    Among patients with heart failure and a reduced ejection fraction, those who received the cardiac myosin activator omecamtiv mecarbil had a lower incidence of a composite of heart-failure events or cardiovascular death at a median of 22 months than those who received placebo. Background The selective cardiac myosin activator omecamtiv mecarbil has been shown to improve cardiac function in patients with heart failure with a reduced ejection fraction. Its effect on cardiovascular outcomes is unknown. Methods We randomly assigned 8256 patients (inpatients and outpatients) with symptomatic chronic heart failure and an ejection fraction of 35% or less to receive omecamtiv mecarbil (using pharmacokinetic-guided doses of 25 mg, 37.5 mg, or 50 mg twice daily) or placebo, in addition to standard heart-failure therapy. The primary outcome was a composite of a first heart-failure event (hospitalization or urgent visit for heart failure) or death from cardiovascular causes. Results During a median of 21.8 months, a primary-outcome event occurred in 1523 of 4120 patients (37.0%) in the omecamtiv mecarbil group and in 1607 of 4112 patients (39.1%) in the placebo group (hazard ratio, 0.92; 95% confidence interval [CI], 0.86 to 0.99; P=0.03). A total of 808 patients (19.6%) and 798 patients (19.4%), respectively, died from cardiovascular causes (hazard ratio, 1.01; 95% CI, 0.92 to 1.11). There was no significant difference between groups in the change from baseline on the Kansas City Cardiomyopathy Questionnaire total symptom score. At week 24, the change from baseline for the median N-terminal pro-B-type natriuretic peptide level was 10% lower in the omecamtiv mecarbil group than in the placebo group; the median cardiac troponin I level was 4 ng per liter higher. The frequency of cardiac ischemic and ventricular arrhythmia events was similar in the two groups. Conclusions Among patients with heart failure and a reduced ejection, those who received omecamtiv mecarbil had a lower incidence of a composite of a heart-failure event or death from cardiovascular causes than those who received placebo. (Funded by Amgen and others; GALACTIC-HF ClinicalTrials.gov number, ; EudraCT number, 2016-002299-28.)
  • article 50 Citação(ões) na Scopus
    Omecamtiv mecarbil in chronic heart failure with reduced ejection fraction: GALACTIC-HF baseline characteristics and comparison with contemporary clinical trials
    (2020) TEERLINK, John R.; DIAZ, Rafael; FELKER, G. Michael; MCMURRAY, John J. V.; METRA, Marco; SOLOMON, Scott D.; ADAMS, Kirkwood F.; ANAND, Inder; ARIAS-MENDOZA, Alexandra; BIERING-SORENSEN, Tor; BOHM, Michael; BONDERMAN, Diana; CLELAND, John G. F.; CORBALAN, Ramon; CRESPO-LEIRO, Maria G.; DAHLSTROM, Ulf; CORREA, Luis E. Echeverria; FANG, James C.; FILIPPATOS, Gerasimos; FONSECA, Candida; GONCALVESOVA, Eva; GOUDEV, Assen R.; HOWLETT, Jonathan G.; LANFEAR, David E.; LUND, Mayanna; MACDONALD, Peter; MAREEV, Vyacheslav; MOMOMURA, Shin-ichi; O'MEARA, Eileen; PARKHOMENKO, Alexander; PONIKOWSKI, Piotr; RAMIRES, Felix J. A.; SERPYTIS, Pranas; SLIWA, Karen; SPINAR, Jindrich; SUTER, Thomas M.; TOMCSANYI, Janos; VANDEKERCKHOVE, Hans; VINEREANU, Dragos; VOORS, Adriaan A.; YILMAZ, Mehmet B.; ZANNAD, Faiez; SHARPSTEN, Lucie; LEGG, Jason C.; ABBASI, Siddique A.; VARIN, Claire; MALIK, Fady I.; KURTZ, Christopher E.
    Aims The safety and efficacy of the novel selective cardiac myosin activator, omecamtiv mecarbil, in patients with heart failure with reduced ejection fraction (HFrEF) is being tested in the Global Approach to Lowering Adverse Cardiac outcomes Through Improving Contractility in Heart Failure (GALACTIC-HF) trial. Here we describe the baseline characteristics of participants in GALACTIC-HF and how these compare with other contemporary trials. Methods and results Adults with established HFrEF, New York Heart Association (NYHA) functional class >= II, ejection fraction <= 35%, elevated natriuretic peptides and either current hospitalization for heart failure or history of hospitalization/emergency department visit for heart failure within a year were randomized to either placebo or omecamtiv mecarbil (pharmacokinetic-guided dosing: 25, 37.5, or 50 mg bid). A total of 8256 patients [male (79%), non-white (22%), mean age 65 years] were enrolled with a mean ejection fraction 27%, ischaemic aetiology in 54%, NYHA class II 53% and III/IV 47%, and median N-terminal pro-B-type natriuretic peptide 1971 pg/mL. Heart failure therapies at baseline were among the most effectively employed in contemporary heart failure trials. GALACTIC-HF randomized patients representative of recent heart failure registries and trials with substantial numbers of patients also having characteristics understudied in previous trials including more from North America (n = 1386), enrolled as inpatients (n = 2084), systolic blood pressure <100 mmHg (n = 1127), estimated glomerular filtration rate <30 mL/min/1.73 m(2) (n = 528), and treated with sacubitril/valsartan at baseline (n = 1594). Conclusions GALACTIC-HF enrolled a well-treated, high-risk population from both inpatient and outpatient settings, which will provide a definitive evaluation of the efficacy and safety of this novel therapy, as well as informing its potential future implementation.
  • article 41 Citação(ões) na Scopus
    Sacubitril/valsartan reduces serum uric acid concentration, an independent predictor of adverse outcomes in PARADIGM-HF
    (2018) MOGENSEN, Ulrik M.; KOBER, Lars; JHUND, Pardeep S.; DESAI, Akshay S.; SENNI, Michele; KRISTENSEN, Soren L.; DUKAT, Andrej; CHEN, Chen-Huan; RAMIRES, Felix; LEFKOWITZ, Martin P.; PRESCOTT, Margaret F.; SHI, Victor C.; ROULEAU, Jean L.; SOLOMON, Scott D.; SWEDBERG, Karl; PACKER, Milton; MCMURRAY, John J. V.
    Aims Elevated serum uric acid concentration (SUA) has been associated with an increased risk of cardiovascular disease, but this may be due to unmeasured confounders. We examined the association between SUA and outcomes as well as the effect of sacubitril/valsartan on SUA in patients with heart failure with reduced ejection fraction (HFrEF) in PARADIGM-HF. Methods and results The association between SUA and the primary composite outcome of cardiovascular death or heart failure (HF) hospitalization, its components, and all-cause mortality was examined using Cox regression analyses among 8213 patients using quintiles (Q1-Q5) of SUA adjusted for baseline prognostic variables including estimated glomerular filtration rate (eGFR), diuretic dose, and log N-terminal pro-brain natriuretic peptide. Change in SUA from baseline over 12 months was also evaluated in each treatment group. Patients in Q5 (SUA >= 8.6 mg/dL) compared with Q1 (< 5.4 mg/dL) were younger (62.8 vs. 64.2 years), more often male (88.7% vs. 63.1%), had lower systolic blood pressure (119 vs. 123 mmHg), lower eGFR (57.4 vs. 76.6 mL/min/1.73m(2)), and greater diuretic use. Higher SUA was associated with a higher risk of the primary outcome (adjusted hazard ratios) Q5 vs. Q1= 1.28 [95% confidence intervals (1.09-1.50), P = 0.003], cardiovascular death [1.44 (1.11-1.77), P = 0.001], HF hospitalization [1.37 (1.11-1.70), P = 0.004], and all-cause mortality [1.36 (1.13-1.64), P = 0.001]. Compared with enalapril, sacubitril/valsartan reduced SUA by 0.24 (0.17-0.32) mg/dL over 12 months (P < 0.0001). Sacubitril/valsartan improved outcomes, irrespective of SUA concentration. Conclusion Serum uric acid concentration was an independent predictor of worse outcomes after multivariable adjustment in patients with HFrEF. Compared with enalapril, sacubitril/valsartan reduced SUA and improved outcomes irrespective of SUA.
  • article 78 Citação(ões) na Scopus
    A putative placebo analysis of the effects of LCZ696 on clinical outcomes in heart failure
    (2015) MCMURRAY, John; PACKER, Milton; DESAI, Akshay; GONG, Jianjian; GREENLAW, Nicola; LEFKOWITZ, Martin; RIZKALA, Adel; SHI, Victor; ROULEAU, Jean; SOLOMON, Scott; SWEDBERG, Karl; ZILE, Michael R.; ANDERSEN, Karl; ARANGO, Juan Luis; ARNOLD, Malcolm; BELOHLAVEK, Jan; BOEHM, Michael; BOYTSOV, Sergey; BURGESS, Lesley; CABRERA, Walter; CHEN, Chen-Huan; ERGLIS, Andrejs; FU, Michael; GOMEZ, Efrain; GONZALEZ, Angel; HAGEGE, Albert-Alain; KATOVA, Tzvetana; KIATCHOOSAKUN, Songsak; KIM, Kee-Sik; BAYRAM, Edmundo; MARTINEZ, Felipe; MERKELY, Bela; MENDOZA, Ivan; MOSTERD, Arend; NEGRUSZ-KAWECKA, Marta; PEUHKURINEN, Keijo; RAMIRES, Felix; REFSGAARD, Jens; SENNI, Michele; SIBULO JR., Antonio S.; SILVA-CARDOSO, Jose; SQUIRE, Iain; STARLING, Randall C.; VINEREANU, Dragos; TEERLINK, John R.; WONG, Raymond
    Aims Although active-controlled trials with reninangiotensin inhibitors are ethically mandated in heart failure with reduced ejection fraction, clinicians and regulators often want to know how the experimental therapy would perform compared with placebo. The angiotensin receptor-neprilysin inhibitor LCZ696 was compared with enalapril in PARADIGM-HF. We made indirect comparisons of the effects of LCZ696 with putative placebos. Methods and results We used the treatment-arm of the Studies Of Left Ventricular Dysfunction (SOLVD-T) as the reference trial for comparison of an ACE inhibitor to placebo and the Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity-Alternative trial (CHARM-Alternative) as the reference trial for comparison of an ARB to placebo. The hazard ratio of LCZ696 vs. a putative placebo was estimated through the product of the hazard ratio of LCZ696 vs. enalapril (active-control) and that of the historical active-control (enalapril or candesartan) vs. placebo. For the primary composite outcome of cardiovascular death or heart failure hospitalization in PARADIGM-HF, the relative risk reduction with LCZ696 vs. a putative placebo from SOLVD-T was 43% (95%CI 3450%; P < 0.0001) with similarly large effects on cardiovascular death (34%, 2144%; P < 0.0001) and heart failure hospitalization (49%, 3958%; P < 0.0001). For all-cause mortality, the reduction compared with a putative placebo was 28% (95%CI 1539%; P < 0.0001). Putative placebo analyses based on CHARM-Alternative gave relative risk reductions of 39% (95%CI 2748%; P < 0.0001) for the composite outcome of cardiovascular death or heart failure hospitalization, 32% (95%CI 1645%; P < 0.0001) for cardiovascular death, 46% (3356%; P < 0.0001) for heart failure hospitalization, and 26% (95%CI 1139%; P < 0.0001) for all-cause mortality. Conclusion These indirect comparisons of LCZ696 with a putative placebo show that the strategy of combined angiotensin receptor blockade and neprilysin inhibition led to striking reductions in cardiovascular and all-cause mortality, as well as heart failure hospitalization. These benefits were obtained even though LCZ696 was added to comprehensive background beta-blocker and mineralocorticoid receptor antagonist therapy.
  • article 544 Citação(ões) na Scopus
    Angiotensin Receptor Neprilysin Inhibition Compared With Enalapril on the Risk of Clinical Progression in Surviving Patients With Heart Failure
    (2015) PACKER, Milton; MCMURRAY, John J. V.; DESAI, Akshay S.; GONG, Jianjian; LEFKOWITZ, Martin P.; RIZKALA, Adel R.; ROULEAU, Jean L.; SHI, Victor C.; SOLOMON, Scott D.; SWEDBERG, Karl; ZILE, Michael; ANDERSEN, Karl; ARANGO, Juan Luis; ARNOLD, J. Malcolm; BELOHLAVEK, Jan; BOEHM, Michael; BOYTSOV, Sergey; BURGESS, Lesley J.; CABRERA, Walter; CALVO, Carlos; CHEN, Chen-Huan; DUKAT, Andrej; DUARTE, Yan Carlos; ERGLIS, Andrejs; FU, Michael; GOMEZ, Efrain; GONZALEZ-MEDINA, Angel; HAGEGE, Albert A.; HUANG, Jun; KATOVA, Tzvetana; KIATCHOOSAKUN, Songsak; KIM, Kee-Sik; KOZAN, Oemer; LLAMAS, Edmundo Bayram; MARTINEZ, Felipe; MERKELY, Bela; MENDOZA, Ivan; MOSTERD, Arend; NEGRUSZ-KAWECKA, Marta; PEUHKURINEN, Keijo; RAMIRES, Felix J. A.; REFSGAARD, Jens; ROSENTHAL, Arvo; SENNI, Michele; JR, Antonio S. Sibulo; SILVA-CARDOSO, Jose; SQUIRE, Iain B.; STARLING, Randall C.; TEERLINK, John R.; VANHAECKE, Johan; VINEREANU, Dragos; WONG, Raymond Ching-Chiew
    Background-Clinical trials in heart failure have focused on the improvement in symptoms or decreases in the risk of death and other cardiovascular events. Little is known about the effect of drugs on the risk of clinical deterioration in surviving patients. Methods and Results-We compared the angiotensin-neprilysin inhibitor LCZ696 (400 mg daily) with the angiotensin-converting enzyme inhibitor enalapril (20 mg daily) in 8399 patients with heart failure and reduced ejection fraction in a double-blind trial. The analyses focused on prespecified measures of nonfatal clinical deterioration. In comparison with the enalapril group, fewer LCZ696-treated patients required intensification of medical treatment for heart failure (520 versus 604; hazard ratio, 0.84; 95% confidence interval, 0.74-0.94; P=0.003) or an emergency department visit for worsening heart failure (hazard ratio, 0.66; 95% confidence interval, 0.52-0.85; P=0.001). The patients in the LCZ696 group had 23% fewer hospitalizations for worsening heart failure (851 versus 1079; P<0.001) and were less likely to require intensive care (768 versus 879; 18% rate reduction, P=0.005), to receive intravenous positive inotropic agents (31% risk reduction, P<0.001), and to have implantation of a heart failure device or cardiac transplantation (22% risk reduction, P=0.07). The reduction in heart failure hospitalization with LCZ696 was evident within the first 30 days after randomization. Worsening of symptom scores in surviving patients was consistently more common in the enalapril group. LCZ696 led to an early and sustained reduction in biomarkers of myocardial wall stress and injury (N-terminal pro-B-type natriuretic peptide and troponin) versus enalapril. Conclusions-Angiotensin-neprilysin inhibition prevents the clinical progression of surviving patients with heart failure more effectively than angiotensin-converting enzyme inhibition.