Clinical studies

Clinical studies

Clinical studies

IP-HCor has a relevant role in national and international projects: to participate in steering committees, to exercise national coordination and to act in event validation committees and as a research center.

Besides that, it also coordinates and offers all the necessary guidance for the own research projects development, with emphasis on applied clinical research, which allows to evaluate the effectiveness of treatments and diagnosis precision.

  • TREAT

    Administration of Ticagrelor in patients with ST-segment elevation myocardial infarction treated with pharmacological thrombolysis

    Randomized, multicenter, phase III, open-label clinical study with endpoint blinded for evaluators. The focus is in exploring the safety and efficacy of Ticagrelor compared to Clopidogrel in patients with ST-segment elevation acute coronary syndrome treated with pharmacological thrombolysis.  A total of 3800 patients will be included in 11 countries: Argentina, Australia, Brazil, Canada, China, Colombia, New Zealand, Peru, Russia e Ukraine. All patients will be followed-up for 12 months. This study is supported by AstraZeneca. To date, 1427 patients have been included distributed across 11 participating countries.

  • RIVER

    To explore the safety and efficacy of Rivaroxaban compared to vitamin K antagonist

    Randomized, phase 2, open-label and non-inferiority clinical trial to explore the safety and efficacy of Rivaroxaban compared to vitamin K antagonist in patients with atrial fibrillation and biological mitral valve prosthesis. The main objective of this project is to explore the effects of Rivaroxaban compared to Warfarin for 12 months on combined safety and efficacy endpoints.  The study expects to include 1000 patients. To date, 193 patients have been included in 31 approved national centers.  This study is funded by the Ministry of Health, through the Program of Support to Institutional Development of SUS – PROADI-SUS, and has the educational support of Bayer Health Care.

  • BRIDGE Cardiovascular Prevention

    Effectiveness of a clinical practice improvement program for therapies in high-risk cardiovascular patients

    Clinical, pragmatic and randomized trial in clusters. The focus is on testing the effectiveness of a program aimed at improving clinical practice for adherence to evidence-based therapies in high-risk cardiovascular patients.  This study aims to assess the impact of a multifaceted educational strategy on adherence to local guidelines for prescribing evidence-based interventions for high-risk cardiovascular patients (cholesterol reducers, aspirin and ACE inhibitors). Another field of evaluation will be related to the impact of a multifaceted educational strategy on prescribing cholesterol-lowering agents and other evidence-based interventions for high-risk cardiovascular patients for reducing these events.  The study expects to include 1680 patients. To date, 1100 patients have been included in 42 approved participating centers.  Thirty-six hospitals from three countries (Brazil, Peru and Argentina) participate in the study. In the first phase, 832 patients were included and, in the second phase, 1800 patients will be included.  This study is funded by the Ministry of Health, through the Program of Support to Institutional Development of SUS – PROADI-SUS, and has the educational support of BOEHRINGER-INGELHEIM.

  • BRIDGE STROKE

    Evidence on the acute care of stroke patients

    Cluster randomized clinical trial to assess whether the multifaceted strategy for improving clinical practice is more effective than usual care regarding the pattern of prescription of evidence-based therapies in the acute care of stroke patients.  The BRIDGE-STROKE study is comprised of two phases. In the first, a registry-based observational study was carried out to document the clinical practice of stroke treatment in the hospitals included, as well as to identify the main barriers to the incorporation of evidence into practice.  For the second phase, a randomized clinical trial will be carried out in clusters, where hospitals were randomized to receive or not receive a multifaceted intervention; after the end of the second phase, centers that had not previously received the tools will have them this time.

  • BASICS

    Balanced Solution versus Saline in Intensive Care Study

    A randomized, factorial study designed to evaluate the impact of two interventions on 90-day mortality in critically ill patients: Plasma-Lyte versus Salina; Rapid expansion (999 mL/h) versus slow (333 mL/h).  The study is in the final regulatory phase (approval in the RECs – Local Research Ethics Committees) and will begin the enrolment of patients in early 2017.  There will be more than 100 centers participating in the study, with a total of 11000 patients to be included.

  • ART

    About 130 intensive care units from different countries participate in the study

    Randomized, pragmatic, academic, multicenter clinical trial. The objective of this study is to determine whether the maximum-stepwise alveolar recruitment strategy associated with the maintenance of PEEP titrated by the static compliance of the respiratory system is capable of increasing the survival of patients with acute respiratory distress syndrome by 28 days compared to the conventional treatment (ARDSNet strategy).  About 130 intensive care units from different countries participate in the study: Brazil, Colombia, Argentina, Chile, Uruguay, Portugal, Italy, Spain, Poland, Malaysia. To date, 2112 patients were screened and 957 randomized.  This study is funded by the Ministry of Health, through the Program of Support to Institutional Development of SUS – PROADI-SUS.

    Publications:
  • SECURE

    To determine the administration of a loading dose of atorvastatin 80 mg

    Randomized, blind-allocation, multicenter, pragmatic, placebo-controlled, clinical study with intention-to-treat analysis. This study aimed to determine whether the administration of a loading dose of atorvastatin 80 mg (previous to percutaneous coronary intervention in a patient with acute myocardial infarction associated with a booster dose 24 hours after the procedure) is able to reduce the rate of major cardiovascular events, defined as a combined endpoint of cardiovascular mortality, peri-procedure myocardial infarction, or new target vessel revascularization.  The study intends to include 4192 patients. Currently, 3156 participants have been already included. Fifty hospitals participate in this study throughout the national territory.  This study is funded by the Ministry of Health, through the Program of Support to Institutional Development of SUS – PROADI-SUS.

  • Brazilian Cardioprotective Diet

    The DICA Br Project proposes a Brazilian cardioprotective diet

    Randomized and multicenter clinical trial to evaluate the effect of the Brazilian cardioprotective diet program on the reduction of events and risk factors in secondary prevention for cardiovascular disease. The DICA Br Project proposes a Brazilian cardioprotective diet considering that, despite the evidence regarding the effectiveness of the Mediterranean diet among interventions in the prevention and control of cardiovascular diseases, adherence to the Mediterranean diet does not correspond to the Brazilian reality. Therefore, the Brazilian cardioprotective diet program, proposed by the DICA Br project, is based on three concepts:
    • dietary prescription guided by the nutritional recommendations of the national guidelines for the treatment of cardiovascular diseases;;
    • a nutritional education program based on playful strategies with accessible food;
    • intense follow-up through individual sessions, group sessions and by phone.
    A total of 2535 subjects were enrolled in 35 approved research centers in Brazill. This study is funded by the Ministry of Health, through the Program of Support to Institutional Development of SUS – PROADI-SUS.
  • GATEWAY

    To evaluate the efficacy of Roux-en-Y gastric bypass (Bariatric Surgery) in reducing the number of antihypertensive medications in hypertensive patients with grade 1 and 2 obesity

    Details: A randomized, unicenter, open-label, phase III clinical trial evaluating the efficacy of Roux-en-Y gastric bypass in reducing antihypertensive drug prescription and its effect on arterial hypertension and other cardiovascular risk factors compared to clinical treatment for obesity and hypertension. The study involved 100 obese subjects of grade 1 and 2, hypertensive, who will be followed up for five years, and the study is expected to be finalized by 2021.  This study is funded by Johnson & Johnson Medical Brasil.

    Publications:
  • BYPASS

    Brazilian registry of cardiovascular surgeries in adults to estimate the incidence of cardiovascular events and death

    Brazilian registry of cardiovascular surgeries in adults to estimate the incidence of cardiovascular events and death. The following surgeries will be included in this registry: coronary-artery bypass grafting; aortic surgery; valve surgery; surgical correction of atrial fibrillation; heart transplantation; mechanical circulatory assistance and congenital cardiopathies in adults. A total of 2462 patients are expected to be included. There are 30 participating hospitals throughout the country and the study has more than 2,000 patients already included. This study is an initiative and intellectual partnership of the SBCCV – Brazilian Society of Cardiovascular Surgery.

  • ACCESS-C

    A hospital-based, cross-sectional observational study (registry) aimed to document characteristics of patients with primary diagnosis of CHC in Brazil

    A study coordinated by the IP HCor, designed by Dr. Maria Lucia Ferraz – UNIFESP to verify the access profile of patients to health services specialized in the treatment of hepatitis C. This study aims to describe the epidemiological scenario of patients with chronic hepatitis C (CHC) in reference centers in Brazil, identifying demographic characteristics, time spent and route traveled to access health services, and identify patients with CHC who are already under follow-up in health services describing their baseline characteristics and eligibility for treatment. With this information, it will be possible to propose changes that improve patient access and contribute to a more effective treatment targeting the needs of the patient. Sixteen centers participate in this study and the goal is to include 2000 participants. This study is sponsored by Indústria Gilead.
  • RECALL

    To document the clinical practice in patients with diagnosed permanent or persistent paroxysmal atrial fibrillation by electrocardiogram.

    Brazilian Registry of Atrial Fibrillation with the objective of documenting the clinical practice in patients diagnosed with permanent or persistent paroxysmal atrial fibrillation (at least two episodes in the last three months) by electrocardiogram, 24-hour Holter or pacemaker/implantable cardioverter defibrillator interrogation.  The Brazilian Cardiovascular Registries are an initiative and intellectual property of the Brazilian Society of Cardiology. To date, 2613 patients have been included in 51 study centers.

    Publications:
  • BREATHE EXTENSION

    Brazilian registry of heart failure with longitudinal follow-up of 90, 180 and 365 days

    Brazilian registry of heart failure with longitudinal follow-up of 90, 180 and 365 days. The study aimed to evaluate the demographic, clinical and prognostic characteristics of patients admitted with a clinical diagnosis of decompensated heart failure, as well as to describe in-hospital mortality, to assess adherence to evidence-based approaches (recommended by guidelines), and to measure quality of care indicators (JCAHO).  In the project’s first phase, 1260 patients were enrolled.  In the BREATHE extension, the aim is to include more 1800 patients, reaching over 3000 patients. Currently, 1330 patients were included in the study. The expectation is that approximately 50 centers from all Brazilian states participate in the study.  Publications:

  • Mapping and evaluation of the Brazilian capacity for conducting clinical trials

    Study coordinated by the Brazilian Association of Collective Health – ABRASCO

    Evaluation and mapping of clinical research centers in Brazil with respect to their infrastructure, workforce and experience. The objective is to provide support for the formulation of policies and actions by Decit/SCTIE and Anvisa, in order to strengthen the national capacity for conducting clinical trials in the National System of Health Innovation.  A study coordinated by the Brazilian Association of Public Health (ABRASCO), as part of the Program to Support Institutional Development of the Unified Health System (Proadi-SUS), in partnership with HCor and the National Cancer Institute (INCA), by request of the Science and Technology Department – Decit of the Secretariat of Science, Technology and Strategic Inputs – SCTIE of the Ministry of Health and the National Health Surveillance Agency – ANVISA.

  • MELODY

    Multicenter, Phase IV, uncontrolled clinical trial of patients with congenital heart disease submitted to percutaneous or periventricular pulmonary valve implantation

    Multicenter, Phase IV, uncontrolled clinical trial of patients with congenital heart disease submitted to percutaneous or periventricular pulmonary valve implantation: clinical impact and quality of life. The study aimed to test the hypothesis that the percutaneous or periventricular pulmonary valve implantation Melody® (Medtronic) in the right ventricular outflow tract is effective and implies a positive clinical impact after the six-month period and one year after the procedure. To date, 19 patients are enrolled in the study in 3 approved centers.

  • ACCEPT

    Register with the objective of recognizing clinical practice in acute coronary syndrome in hospitals

    Register with the objective of recognizing the clinical practice in acute coronary syndrome in public and private hospitals, in order to identify the adherence of the incorporation of diagnostic methods and therapeutic interventions, as well as to assess the incidence and predictors of serious events. In total, 5018 patients were included. The Brazilian Cardiovascular Registries are an initiative and intellectual property of the Brazilian Society of Cardiology.

    Publications:

    Ministry of Health and National Health Surveillance Agency – ANVISA.

  • ACT

    N-Acetylcysteine in the Prevention of Contrast-Induced Nephropathy

    Randomized, pragmatic, academic, national, multicenter, placebo-controlled, blind clinical trial. Carried out to evaluate the efficacy of N-acetylcysteine in the prevention of contrast-induced nephropathy as primary endpoint. In this study, patients who underwent iodinated contrast procedures were randomized to receive either 1200 mg of N-acetylcysteine or placebo in 4 doses every 12 hours, with two doses being preferably given before and two after the procedure. Both arms of the study (active ingredient and placebo) received hydration before and after the contrast procedure. The definition of contrast-induced nephropathy was elevated serum creatinine by 25% compared to baseline creatinine. The randomization was central, via the web, with blind allocation and the analyses followed the methodological principle of intention-to-treat. Forty-six institutions from all Brazilian regions participated, including 2308 patients.  This study was funded by the Ministry of Health, through the Program of Support to Institutional Development of SUS – PROADI-SUS.

    Publications:
  • BLESS

    Evaluates the feasibility of continuous electrical stimulation of the ventromedial hypothalamus (VMH) bilaterally for the treatment of obesity

    Experimental, phase I, prospective, uncontrolled, single-center study to evaluate the feasibility of continuous electrical stimulation of the ventromedial hypothalamus (VMH) bilaterally in 06 patients with morbid obesity. In addition to safety, weight loss was assessed during the 12-month follow-up of the patients in the study. The results are under review for future publications.  This study was funded by the Ministry of Health, through the Program of Support to Institutional Development of SUS – PROADI-SUS.

  • BRIDGE ACS

    Project to improve the quality of care in public hospitals linked to SUS in Acute Coronary Syndrome

    Project to improve the quality of care, through the incorporation of evidence-based interventions, in public hospitals linked to the Unified Health System (SUS) in Acute Coronary Syndrome (ACS). Pragmatic, cluster randomized clinical trial to assess whether the multifaceted strategy for improving clinical practice is more effective than usual care for the pattern of evidence-based interventions in the care of ACS patients. A total of 1150 patients were included in 34 emergency units (clusters).  BRIDGE-ACS demonstrated that the multifaceted strategy was effective in significantly increasing the adoption of evidence-based interventions in the care of ACS patients.  This study was funded by the Ministry of Health, through the Program of Support to Institutional Development of SUS – PROADI-SUS.

    Publications:
  • CETRAT

    Evaluate the efficacy of pharmacotherapy (nicotine replacement) associated with cognitive-behavioral therapy

    A randomized, one-year follow-up clinical trial to assess the efficacy of pharmacotherapy (nicotine replacement) associated with group cognitive-behavioral therapy and compared to standard nicotine replacement therapy for smoking cessation for patients intending to quit smoking, in addition to determine the effect of treatment on the level of anxiety, depression, and to verify the relapse rate at 52 weeks after randomization of the groups. This study was funded by the Ministry of Health, through the Program of Support to Institutional Development of SUS – PROADI-SUS.

  • CHAIN

    Brazilian registry of cardiac catheterization in congenital heart diseases.

    Details: Brazilian registry of cardiac catheterization in congenital heart diseases. In total, 1720 patients with congenital heart diseases were included throughout the national territory. Publications:

  • CHECKLIST – ICU TRIAL

    Randomized cluster clinical trial aimed to verify whether the use of intervention including checklists with evaluation of daily care goals during the multidisciplinary visit and clinician prompting can reduce hospital mortality of patients admitted to intensive care units.

    Randomized cluster clinical trial aimed to verify whether the use of intervention including checklists with evaluation of daily care goals during the multidisciplinary visit and clinician prompting can reduce hospital mortality of patients admitted to intensive care units. In addition, the participating ICUs were characterized according to the criteria of the relevant ANVISA resolutions (RDC no. 7/2010 and RDC no. 26/2012), and evaluations were carried out by the team of professionals who work in the care of critically ill patients using the Safety Attitudes Questionnaire (SAQ).  A total of 13635 patients were included and more than 12791 professionals answered SAQ in 118 intensive care units (ICUs) in Brazil.  The main results were the improved quality of care provided to critically ill patients and the improved safety climate with the adoption of checklists and clinical alerts, although there was no impact on mortality and other clinical endpoints. This study was funded by the Banco Nacional de Desenvolvimento Econômico e Social – BNDES, through the Program of Support to Institutional Development of SUS – PROADI-SUS.

    Publicações:
  • LOAD

    Atorvastatin for the prevention of cardiovascular events in patients submitted to noncardiac surgery

    The main objective of this project is to evaluate the feasibility of conducting a randomized, multicenter clinical trial at the perioperative period and the safety and efficacy of the use of generic atorvastatin administered in the preoperative period of noncardiac surgeries to reduce major vascular events, as well as its action in the prevention of elevation of myocardial necrosis markers (troponin) in the postoperative period of patients at high cardiovascular risk over 40 years of age, submitted to noncardiac surgery with expected hospitalization for at least 24 hours. The study included 648 patients and 32 approved centers.  The study was neutral in its results, not demonstrating a reduction in the major cardiovascular complications after the use of statin in the perioperative period. However, it has been demonstrated that a large, randomized, multicenter, blind clinical trial with statin use during the perioperative period in patients without prior statin use is feasible, and a definitive study should be carried out to definitively establish the efficacy and safety of statin in this population of patients.

    Publications:
  • MANAGE

    A large, randomized, international, placebo-controlled clinical trial to assess the impact of dabigatran (direct thrombin inhibitor) and omeprazole (proton pump inhibitor) in patients with myocardial injury after noncardiac surgery

    Study coordinated in Brazil by IP HCor. The MANAGE Study is an international RCT that will include patients who have suffered MINS, who will be randomized to receive dabigatran or placebo. In addition, the MANAGE Study will use a 2X2 partial factorial design to randomize patients not treated with a PPI to receive omeprazole or placebo. Patients, health professionals, data collection professionals, endpoint assessors and investigators (e.g. Steering Committee members) will all be blind to group allocation.  This project aims to include 3200 patients in the study. At the moment, 1399 participants were included worldwide (Brazil, Argentina, Peru, Colombia, USA, Canada, Spain, Italy, Poland, Denmark, Czech Republic, India, Australia, United Kingdom, South Africa), 466 participating in the factorial of Omeprazole. In Brazil, we included 31 participants in the study and, among them, 08 participating in the factorial of Omeprazole.

  • PILL PILOT

    Program to Improve Life and Longevity

    Randomized, international, multicenter, placebo-controlled clinical trial of four fixed-dose combined active ingredients in subjects at increased risk of cardiovascular disease. The main objective was to evaluate the efficacy (change in systolic blood pressure and LDL cholesterol) and the polypill tolerability in a population presenting an absolute risk of a major cardiovascular event in the next 5 years of 7.5% or more, based on the risk predicted by Framingham score. The pilot study included 378 patients. Publications:

  • POISE 2

    Assess the impact of clonidine and acetylsalicylic acid (ASA) on patients submitted to noncardiac surgery

    Randomized, international, academic, controlled and factorial design clinical trial. Carried out to assess the impact of clonidine and acetylsalicylic acid (ASA) on patients submitted to noncardiac surgery who were at risk for a perioperative cardiovascular event. Publications:

  • PREVER

    Evaluates the efficacy of a population-based intervention to prevent hypertension and target organ damage

    Randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy, safety and feasibility of a population-based intervention to prevent the incidence of hypertension and the development of target organ damage. A total of 1250 participants aged between 30 and 70 years with pre-hypertension were included.  This research was led by the Division of Cardiology of the Clinical Hospital of Porto Alegre, Federal University of Rio Grande do Sul. IP-HCor participated in study data management. Publications:

  • PROTECT

    Prophylaxis of thromboembolic events in critically ill patients

    Randomized, multicenter, blinded clinical trial, commissioned by the Canadian government and developed by the McMaster University (Canada), with the HCor Research Institute (IP – HCor) as national coordinator. The focus is on the comparison of efficacy between two classes of heparins – unfractionated heparin and low molecular weight heparin – in the prevention of thromboembolic events in patients admitted to Intensive Care Units.

    Publications:
  • QUALITI

    Quality Improvement Program in Intensive Care

    Programa aprimoramento de QUALIdade assistencial em Terapia Intensiva. [quality improvement program in intensive care]. The objective is to improve care quality in intensive care units of hospitals geographically distant in Brazil by adopting evidence-based medical practices adapted to the local reality. This study was funded by the Ministry of Health, through the Program of Support to Institutional Development of SUS – PROADI-SUS.

  • REACT

    Recognize clinical practice regarding the care of high-risk cardiovascular patients.

    Register with the objective of recognizing the clinical practice regarding the care of the high-risk cardiovascular patients, in order to identify the adherence of the incorporation of diagnostic methods and therapeutic interventions, as well as to assess the incidence and predictors of serious events. In total, 5000 patients were included. The Brazilian Cardiovascular Registries are an initiative and intellectual property of the Brazilian Society of Cardiology. Publications:

  • TREND

    Proposed study of peripheral trigeminal stimulation for the treatment of resistant major depression

    Randomized, single-center, double-blind, electrical stimulation, placebo-controlled clinical trial to evaluate the efficacy of trigeminal stimulation in patients with Major Unipolar Depression disorder. Seventy patients were included, of whom 50 received external trigeminal stimulation and 20 received subcutaneous trigeminal stimulation during the 12 months of study follow-up.  The results are under review for future publications. This study was funded by the Ministry of Health, through the Program of Support to Institutional Development of SUS – PROADI-SUS.

  • VISION

    Vascular events In noncardiac Surgery patIents cOhort evaluatioN study

    Study evaluating vascular events in a cohort of patients submitted to non-cardiac surgery. It is the largest study of history in the area of noncardiac perioperative medicine. It is an academic, prospective, multicenter, international, observational, cohort study involving 40000 patients in 10 countries. The main objectives are to determine the incidence of major vascular events, the optimal clinical model (risk index) to predict major vascular events in the perioperative period, to which extent the measurement of troponin after surgery may identify silent myocardial infarctions and predict major vascular events within 1 year. This research is the product of an international collaboration led by the Canadian McMaster University, in which IP-HCor researchers participated effectively in the preparation of the protocol.  This study was funded by the Ministry of Health, through the Program of Support to Institutional Development of SUS – PROADI-SUS.

    Publications: