ROGERIO DE SOUZA
Projetos de Pesquisa
Unidades Organizacionais
Departamento de Cardio-Pneumologia, Faculdade de Medicina - Docente
Instituto do Coração, Hospital das Clínicas, Faculdade de Medicina - Médico
LIM/09 - Laboratório de Pneumologia, Hospital das Clínicas, Faculdade de Medicina - Líder
Instituto do Coração, Hospital das Clínicas, Faculdade de Medicina - Médico
LIM/09 - Laboratório de Pneumologia, Hospital das Clínicas, Faculdade de Medicina - Líder
18 resultados
Resultados de Busca
Agora exibindo 1 - 10 de 18
- Clinical, demographic and functional evaluation of patients with hypersensitivity pneumonitis and their comparison based on current diagnostic criteria(2023) BRIDI, Guilherme Das Posses; SILVA, Bianca Freire Da; CUNHA, Marieta Cabral Amaral Da; QUEIROZ, Douglas Silva; ALVES- JR., Jose Leonidas; SALGE, Joao Marcos; CARVALHO, Celso R. F. De; KAIRALLA, Ronaldo Adib; SOUZA, Rogerio De; BALDI, Bruno Guedes
- Renal Replacement Therapy in Patients With Acute Decompensated Pulmonary Hypertension Admitted to the Intensive Care Unit(2022) GARCIA, Marcos; SOUZA, Rogerio; CARUSO, PedroBackground: Pulmonary arterial hypertension and chronic thromboemholic pulmonary hypertension (PH) are characterized hemodynamically by pre-capillary PH. Acute worsening of systemic congestion and/or reduced right ventricular flow output in patients with pre-capillary PH characterizes an episode of acute decompensated PH. Acute kidney injury (AKI) is a common complication in this population and those patients frequently use renal replacement therapy (RRT). Predictors and timing for RRT in acute decompensated PH are unknown and mortality of patients who require this therapy is high. We hypothesize that AKI and hypervolemia are associated with use of RRT during episodes of acute decompensated PH in patients with pre-capillary PH requiring intensive care unit (ICU) admission. Aim: Explore variables associated with RRT use, develop a decision tree model to predict use of RRT in acute decompensated PH and analyze ICU, in-hospital and 90-days mortality in this population. Materials and methods: Multicenter retrospective cohort study including patients with pulmonary arterial hypertension and chronic thromboembolic PH with unplanned admission in the ICU for acute decompensated PH. Acute decompensated PH was defined by acute right ventricular failure leading to low cardiac output and elevated right ventricle filling pressures. We employed two multivariable logistic regression models using directed acyclic graphs to identify confounders. Unadjusted and adjusted odds ratios and 95% confidence intervals were used to measure the association between variables and RRT use. Results: Some 73 patients were included, 16.4% (n=12) of patients required RRT during ICU stay. In the univariate analysis, right atrial pressure (RAP) on last right heart catheterization, and creatinine upon ICU admission were associated with use of RRT and were included in the multivariable model and in the decision tree model. The decision tree model based on RAP and creatinine showed sensitivity of 58.3% and specificity of 100% with area under the receiver operating characteristic curve of 0.81 for predicting RRT use in the ICU. In-hospital mortality and 90-days mortality of patients who used RRT were higher than in patients that did not use RRT (75.0% vs. 34.4%, p < 0.01 and 83.3% vs. 42.6%, p = 0.01, respectively). Conclusion: The decision tree model based on creatinine upon admission and RAP, which is a surrogate of hypervolemia, can identify patients at risk for RRT. Increased ICU, in-hospital, and 90-days mortality were observed in patients with acute decompensated PH who used RRT in the ICU.
- Phase 3 Trial of Sotatercept for Treatment of Pulmonary Arterial Hypertension(2023) HOEPER, Marius M.; BADESCH, David B.; GHOFRANI, H. Ardeschir; GIBBS, J. Simon R.; GOMBERG-MAITLAND, Mardi; MCLAUGHLIN, Vallerie V.; PRESTON, Ioana R.; SOUZA, Rogerio; WAXMAN, Aaron B.; GRUENIG, Ekkehard; KOPEC, Grzegorz; MEYER, Gisela; OLSSON, Karen M.; ROSENKRANZ, Stephan; XU, Yayun; MILLER, Barry; FOWLER, Marcie; BUTLER, John; KOGLIN, Joerg; PENA, Janethe de Oliveira; HUMBERT, MarcBACKGROUNDPulmonary arterial hypertension is a progressive disease involving proliferative remodeling of the pulmonary vessels. Despite therapeutic advances, the disease-associated morbidity and mortality remain high. Sotatercept is a fusion protein that traps activins and growth differentiation factors involved in pulmonary arterial hypertension.METHODSWe conducted a multicenter, double-blind, phase 3 trial in which adults with pulmonary arterial hypertension (World Health Organization [WHO] functional class II or III) who were receiving stable background therapy were randomly assigned in a 1:1 ratio to receive subcutaneous sotatercept (starting dose, 0.3 mg per kilogram of body weight; target dose, 0.7 mg per kilogram) or placebo every 3 weeks. The primary end point was the change from baseline at week 24 in the 6-minute walk distance. Nine secondary end points, tested hierarchically in the following order, were multicomponent improvement, change in pulmonary vascular resistance, change in N-terminal pro-B-type natriuretic peptide level, improvement in WHO functional class, time to death or clinical worsening, French risk score, and changes in the Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT) Physical Impacts, Cardiopulmonary Symptoms, and Cognitive-Emotional Impacts domain scores; all were assessed at week 24 except time to death or clinical worsening, which was assessed when the last patient completed the week 24 visit.RESULTSA total of 163 patients were assigned to receive sotatercept and 160 to receive placebo. The median change from baseline at week 24 in the 6-minute walk distance was 34.4 m (95% confidence interval [CI], 33.0 to 35.5) in the sotatercept group and 1.0 m (95% CI, -0.3 to 3.5) in the placebo group. The Hodges-Lehmann estimate of the difference between the sotatercept and placebo groups in the change from baseline at week 24 in the 6-minute walk distance was 40.8 m (95% CI, 27.5 to 54.1; P < 0.001). The first eight secondary end points were significantly improved with sotatercept as compared with placebo, whereas the PAH-SYMPACT Cognitive-Emotional Impacts domain score was not. Adverse events that occurred more frequently with sotatercept than with placebo included epistaxis, dizziness, telangiectasia, increased hemoglobin levels, thrombocytopenia, and increased blood pressure.CONCLUSIONSIn patients with pulmonary arterial hypertension who were receiving stable background therapy, sotatercept resulted in a greater improvement in exercise capacity (as assessed by the 6-minute walk test) than placebo. (Funded by Acceleron Pharma, a subsidiary of MSD; STELLAR ClinicalTrials.gov number, .)
- Loss of response to calcium channel blockers after long-term follow-up treatment in patients with idiopathic pulmonary arterial hypertension(2023) PILOTO, Bruna; FERNANDES, Caio Julio Cesar dos Santos; JARDIM, Carlos; CASTRO, Marcela; ALVES- JR., Jose Leonidas; SOUZA, RogerioIdiopathic pulmonary arterial hypertension (PAH) patients with a positive response to acute vasodilator challenge and a clinical response to calcium channel blockers (CCBs) for at least one year are traditionally designated true responders. Nevertheless, little is known about a sustained response to CCBs over longer periods of time. We evaluated the loss of response to CCBs after long-term treatment in a cohort of idiopathic PAH patients previously classified as being true responders. Our data suggest that idiopathic PAH patients can lose clinical response to CCBs even after one year of clinical stability, reinforcing the need for constant multidimensional reevaluation to assess the need for targeted PAH therapies and to classify these patients correctly.
- Baseline characteristics of patients included into the ERS Clinical Research Collaboration: ""Pulmonary Hemodynamics during Exercise - Research Network"" (PEX-NET) registry(2022) KOVACS, G.; HUMBERT, M.; HERVE, P.; AVIAN, A.; GALIE, N.; LEWIS, G.; SOUZA, R.; ULRICH, S.; NOORDEGRAAF, A. Vonk; ANDERSEN, M.; BARBERA, J. A.; BLANCO, I; CONDLIFFE, R.; D'ALTO, M.; EGENLAUF, B.; EWERT, R.; GRUENIG, E.; HEINE, A.; HERKENRATH, S.; HSU, S.; KASPEROWICZ, K.; MAK, S.; MARON, B.; MCCABE, C.; OLIVEIRA, R.; ROSENKRANZ, S.; SAVALE, L.; SAXER, S.; SYSTROM, D.; TEDFORD, R.; TORBICKI, A.; OLSCHEWSKI, H.
- Unusual Forms of Pulmonary Hypertension(2023) PARENTE, Yuri de Deus Montalverne; SILVA, Natalia Fernandes da; SOUZA, Rogerio
- Reply to: ""Mortality and prognostic factors in connective tissue disease-associated pulmonary arterial hypertension patients complicated with right heart failure""(2023) GARCIA, Marcos Vinicius Fernandes; SOUZA, Rogerio; CARUSO, Pedro
- Sotatercept for the treatment of pulmonary arterial hypertension: PULSAR open-label extension(2023) HUMBERT, Marc; MCLAUGHLIN, Vallerie; GIBBS, J. Simon R.; GOMBERG-MAITLAND, Mardi; HOEPER, Marius M.; PRESTON, Ioana R.; SOUZA, Rogerio; WAXMAN, Aaron B.; GHOFRANI, Hossein-Ardeschir; SUBIAS, Pilar Escribano; FELDMAN, Jeremy; MEYER, Gisela; MONTANI, David; OLSSON, Karen M.; MANIMARAN, Solaiappan; PENA, Janethe de Oliveira; BADESCH, David B.Background In participants with pulmonary arterial hypertension, 24 weeks of sotatercept resulted in a significantly greater reduction from baseline in pulmonary vascular resistance than placebo. This report characterises the longer-term safety and efficacy of sotatercept in the PULSAR open-label extension. We report cumulative safety, and efficacy at months 18-24, for all participants treated with sotatercept. Methods PULSAR was a phase 2, randomised, double-blind, placebo-controlled study followed by an open-label extension, which evaluated sotatercept on top of background pulmonary arterial hypertension therapy in adults. Participants originally randomised to placebo were re-randomised 1:1 to sotatercept 0.3 or 0.7 mg center dot kg(-1) ( placebo-crossed group); those initially randomised to sotatercept continued the same sotatercept dose (continued-sotatercept group). Safety was evaluated in all participants who received >= 1 dose of sotatercept. The primary efficacy endpoint was change from baseline to months 18-24 in pulmonary vascular resistance. Secondary endpoints included 6-min walk distance and functional class. Two prespecified analyses, placebo-crossed and delayed-start, evaluated efficacy irrespective of dose. Results Of 106 participants enrolled in the PULSAR study, 97 continued into the extension period. Serious treatment-emergent adverse events were reported in 32 (30.8%) participants; 10 (9.6%) reported treatment-emergent adverse events leading to study discontinuation. Three (2.9%) participants died, none considered related to study drug. The placebo-crossed group demonstrated significant improvement across primary and secondary endpoints and clinical efficacy was maintained in the continued-sotatercept group. Conclusion These results support the longer-term safety and durability of clinical benefit of sotatercept for pulmonary arterial hypertension.
- Long-term survival after acute decompensated pulmonary hypertension: A propensity-score matched study(2023) GARCIA, M. V. F.; SOUZA, R.; CARUSO, P.
- Risk assessment validation in patients with pulmonary arterial hypertension: Data from a Southern Brazil registry (RESPHIRAR study)(2023) SPILIMBERGO, Fernanda Brum; RODRIGUES, Roger Pirath; DIAS-PINTO, Marcelo Credidio; BLANCO, Daniela Cavalet; BARBIERI, Glaucia Maria; ANDRADE-LIMA, Marina; FAGUNDES, Ariovaldo Leal; GAZZANA, Marcelo Basso; RONCATO, Gabriela; MELLO, Marcelo Martins; WATTE, Guilherme; ASSMANN, Tais Silveira; CAURIO, Cassia Ferreira Braz; SOUZA, Rogerio; MEYER, Gisela Martina BohnsPulmonary arterial hypertension (PAH) is a severe and progressive disease characterized by increased pulmonary vascular resistance, ultimately leading to right heart failure and death. Registries are a valuable tool in the research of rare conditions such as PAH. Moreover, the risk assessment strategy has been validated in European and North American registries and has been reported to provide an accurate prediction of mortality and the clinical advantage of reaching low-risk status. However, there is no available data from Brazil. Thus, the aim of the present study was to describe the characteristics of a sample of PAH from Southern Brazil and to retrospectively validate the risk assessment at our population. The RESPHIRAR is a retrospective and multicentric registry on pulmonary hypertension. With a join collaboration from nine centers in Southern Brazil, demographics, clinical presentation, and hemodynamics data of PAH were collected between 2007 and 2017. Moreover, the REVEAL 2.0 and REVEAL 2.0 Lite risk assessments were validated in our population. Overall, 370 PAH patients were included in the present study. Patients were predominantly female (78.5%) and had a mean age of 41.8 +/- 18.8 years. Most patients (33.4%) had idiopathic PAH, 30.2% had PAH associated with congenital heart disease, and 23.5% had PAH associated with connective tissue disease. The low-risk group showed significantly lower mortality than the intermediated- or high-risk group at diagnosis (p < 0.05). In conclusion, our data suggest that REVEAL 2.0 and REVEAL 2.0 Lite risk assessments can predict mortality risk in PAH patients in Southern Brazil.