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.
  • 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 14 Citação(ões) na Scopus
    Post hoc analyses of SHIFT and PARADIGM-HF highlight the importance of chronic Chagas' cardiomyopathy Comment on: ""Safety profile and efficacy of ivabradine in heart failure due to Chagas heart disease: a post hoc analysis of the SHIFT trial"" by Bocchi et al.
    (2018) RAMIRES, Felix J. A.; MARTINEZ, Felipe; GOMEZ, Efrain A.; DEMACQ, Caroline; GIMPELEWICZ, Claudio R.; ROULEAU, Jean L.; SOLOMON, Scott D.; SWEDBERG, Karl; ZILE, Michael R.; PACKER, Milton; MCMURRAY, John J. V.
  • 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 1 Citação(ões) na Scopus
    Omecamtiv Mecarbil in Black Patients With Heart Failure and Reduced Ejection Fraction Insights From GALACTIC-HF
    (2023) LANFEAR, David E.; NJOROGE, Joyce N.; ADAMS, Kirkwood F.; ANAND, Inder; FANG, James C.; RAMIRES, Felix; SLIWA-HAHNLE, Karen; BADAT, Aysha; BURGESS, Lesley; GORODESKI, Eiran Z.; WILLIAMS, Celeste; DIAZ, Rafael; FELKER, Gary M.; MCMURRAY, John J. V.; METRA, Marco; SOLOMON, Scott; MIAO, Zi Michael; CLAGGETT, Brian L.; HEITNER, Stephen B.; KUPFER, Stuart; MALIK, Fady I.; TEERLINK, John R.
    BACKGROUND Omecamtiv mecarbil improves cardiovascular outcomes in patients with heart failure (HF) with reduced ejection fraction (EF). Consistency of drug benefit across race is a key public health topic. OBJECTIVES The purpose of this study was to evaluate the effect of omecamtiv mecarbil among self-identified Black patients. METHODS In GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure) patients with symptomatic HF, elevated natriuretic peptides, and left ventricular ejection fraction (LVEF) #35% were randomized to omecamtiv mecarbil or placebo. The primary outcome was a composite of time to first event of HF or cardiovascular death. The authors analyzed treatment effects in Black vs White patients in countries contributing at least 10 Black participants. RESULTS Black patients accounted for 6.8% (n = 562) of overall enrollment and 29% of U.S. enrollment. Most Black patients enrolled in the United States, South Africa, and Brazil (n = 535, 95%). Compared with White patients enrolled from these countries (n = 1,129), Black patients differed in demographics, comorbid conditions, received higher rates of medical therapy and lower rates of device therapies, and experienced higher overall event rates. The effect of omecamtiv mecarbil was consistent in Black vs White patients, with no difference in the primary endpoint (HR = 0.83 vs 0.88, P-interaction = 0.66), similar improvements in heart rate and N-terminal pro-B-type natriuretic peptide, and no sig-nificant safety signals. Among endpoints, the only nominally significant treatment-by-race interaction was the placebo -corrected change in blood pressure from baseline in Black vs White patients (+3.4 vs-0.7 mm Hg, P for interaction = 0.02). CONCLUSIONS GALACTIC-HF enrolled more Black patients than other recent HF trials. Black patients treated with ome-camtiv mecarbil had similar benefit and safety compared with White counterparts. (J Am Coll Cardiol HF 2023;11:569-579) & COPY; 2023 The Authors.
  • 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.
  • article 118 Citação(ões) na Scopus
    Comparing LCZ696 With Enalapril According to Baseline Risk Using the MAGGIC and EMPHASIS-HF Risk Scores
    (2015) SIMPSON, Joanne; JHUND, Pardeep S.; CARDOSO, Jose Silva; MARTINEZ, Felipe; MOSTERD, Arend; RAMIRES, Felix; RIZKALA, Adel R.; SENNI, Michele; SQUIRE, Iain; GONG, Jianjian; LEFKOWITZ, Martin P.; SHI, Victor C.; DESAI, Akshay S.; ROULEAU, Jean L.; SWEDBERG, Karl; ZILE, Michael R.; MCMURRAY, John J. V.; PACKER, Milton; SOLOMON, Scott D.
    BACKGROUND Although most patients in the PARADIGM-HF (Prospective Comparison of ARNI With ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure) trial had mild symptoms, there is a poor correlation between reported functional limitation and prognosis in heart failure. OBJECTIVES The aim of this study was to examine the spectrum of risk in PARADIGM-HF and the effect of LCZ696 across that spectrum. METHODS This study analyzed rates of the primary composite outcome of cardiovascular death or heart failure hospitalization, its components, and all-cause mortality using the MAGGIC (Meta-Analysis Global Group in Chronic Heart Failure) and EMPHASIS-HF (Eplerenone in Mild Patients Hospitalization and Survival Study in Heart Failure) risk scores to categorizepatients. The authors determined whether risk, on the basis of these scores, modified the treatment effect of LCZ696. RESULTS The complete MAGGIC risk score was available for 8,375 of the 8,399 patients in PARADIGM-HF. The median MAGGIC score was 20 (IQR: 16 to 24). An increase of 1 point was associated with a 6% increased risk for the primary endpoint (p < 0.001) and a 7% increased risk for cardiovascular death (p < 0.001). The benefit of LCZ696 over enalapril for the primary endpoint was similar across the spectrum of risk (p = 0.159). Treating 100 patients for 2 years with LCZ696 instead of enalapril led to 7 fewer patients in the highest quintile of risk experiencing primary outcomes, compared with 3 in the lowest quintile. Analyses using the EMPHASIS-HF risk score gave similar findings. CONCLUSIONS Although most PARADIGM-HF patients had mild symptoms, many were at high risk for adverse outcomes and obtained a large absolute benefit from LCZ696, compared with enalapril, over a relatively short treatment period. LCZ696's benefit was consistent across the spectrum of risk. (PARADIGM-HF trial [Prospective Comparison of ARNI With ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure]; NCT01035255) (C) 2015 by the American College of Cardiology Foundation.