2013 Late-Breaking Clinical Trial Abstracts
2013; Lippincott Williams & Wilkins; Volume: 128; Issue: 24 Linguagem: Inglês
10.1161/01.cir.0000441317.09886.ce
ISSN1524-4539
AutoresNishat Siddiqi, Margaret Bruce, Christopher Neil, Graeme MacLennan, Seonaidh Cotton, Sofia Papadopoulou, Baljit Jagpal, Sue Brown, Fátima Pérez González, Satnam Singh, Konstantin Schwarz, Martin Feelisch, Nicholas Bunce, Pitt Lim, David Hildick‐Smith, John D. Horowitz, Melanie Madhani, Nicholas A. Boon, Dana Dawson, Juan Carlos Kaski, Michael Frenneaux, Dept of Cardiovascular Rsch, Univ of Aberdeen, Aberdeen, United Kingdom, Health Sciences Building, Centre for Healthcare Randomised Trials, Aberdeen, United Kingdom, Cardiovascular Sciences Rsch Centre, St George's Univ of London, London London, United Kingdom, Faculty of Medicine, Univ of Southampton, Southampton, Cardiology Dept, St George's Healthcare NHS Trust, Cardiology Research Unit, Brighton and Sussex Univ Hospitals, Brighton, United Kingdom, Basil Hetzel Unit for Translational Health Research, The Queen Elizabeth Hospital, Adelaide, Centre for Cardiovascular Sciences, U Birmingham, Birmingham, United Kingdom, Centre for Cardiovascular Sciences, Univ of Edinburgh, Edinburgh, United Kingdom, School of Medicine and Dentistry, Univ of Aberdeen, Aberdeen,
Tópico(s)Advanced Causal Inference Techniques
ResumoHomeCirculationVol. 128, No. 242013 Late-Breaking Clinical Trial Abstracts Free AccessResearch ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessResearch ArticlePDF/EPUB2013 Late-Breaking Clinical Trial Abstracts Originally published17 Dec 2013https://doi.org/10.1161/01.cir.0000441317.09886.ceCirculation. 2013;128:2704–2722Late-Breaking Clinical Trials: Acute Cardiovascular and Cerebrovascular CareNitrites in Acute Myocardial InfarctionNishat Siddiqi1, Margaret Bruce1, Christopher J. Neil1, Graeme MacLennan2, Seonaidh Cotton2, Sofia A. Papadopoulou3, Baljit Jagpal1, Sue Brown3, Fatima Perez Gonzalez3, Satnam Singh1, Konstantin Schwarz1, Martin Feelisch4, Nicholas Bunce5, Pitt O Lim5, David Hildick-Smith6, John Horowitz7, Melanie Madhani8, Nicholas Boon9, Dana Dawson10, Juan-Carlos Kaski3, Michael P Frenneaux10. 1Dept of Cardiovascular Rsch, Univ of Aberdeen, Aberdeen, United Kingdom, 2Health Sciences Building (third floor), Centre for Healthcare Randomised Trials (CHaRT), Aberdeen, United Kingdom, 3Cardiovascular Sciences Rsch Centre, St George's Univ of London, London, United Kingdom, 4Faculty of Medicine, Univ of Southampton, Southampton, 5Cardiology Dept, St George's Healthcare NHS Trust, 6Cardiology Research Unit, Brighton and Sussex Univ Hospitals, Brighton, United Kingdom, 7Basil Hetzel Unit for Translational Health Research, The Queen Elizabeth Hospital, Adelaide, 8Centre for Cardiovascular Sciences, Univ of Birmingham, Birmingham, United Kingdom, 9Centre for Cardiovascular Sciences, Univ of Edinburgh, Edinburgh, United Kingdom, 10School of Medicine and Dentistry, Univ of Aberdeen, AberdeenIntroduction:Despite reperfusion therapy for acute myocardial infarction (AMI), heart failure remains a major sequel. Reperfusion leads to further damage, described as ischemia-reperfusion-injury (IRI). This contributes up to 50% of the final infarct size. In pre-clinical models nitrite potently protects against IRI in the heart and other organs. Hypothesis:Intravenous (iv) sodium nitrite, administered immediately before opening of the infarct-related artery, results in significant reduction of IRI in patients with acute ST elevation MI (STEMI). Methods:In this phase II, randomised, placebo-controlled, double-blind, multicentre trial, 220 patients with first acute STEMI and TIMI 0 or 1 flow were randomised in a double-blind fashion to 70micromol iv sodium nitrite or matching placebo over 5 minutes immediately preceding opening of the infarct-related artery. The primary end point was the difference in infarct size between sodium nitrite and placebo groups using cardiovascular magnetic resonance imaging (CMR) at 6-8 days following AMI, adjusted for area at risk (AAR), diabetes status and center. Secondary end points comprised (i) Infarct size (CMR) at six months; (ii) plasma CK and Troponin I measured over 72 hours after injection of the study medication; (iii) Infarct size corrected for AAR measured using T2 weighted CMR; (iv) left ventricular (LV) ejection fraction and LV end systolic volume index measured by CMR at 6-8 days and at six months. Results: Infarct size at 6-8 days by CMR did not differ between nitrite and placebo groups (effect size -0.7% 95%CI -2.2,+0.7; p=0.34). There were no significant differences in the predefined secondary end points. There was no treatment effect in non-diabetics, but in diabetics was -4.5% (95%CI -8.8,-0.2; p=0.041) but the interaction was not significant (p=0.067). Conclusion: Sodium nitrite administered iv immediately prior to reperfusion in patients with acute STEMI did not reduce infarct size. A potential benefit in diabetics warrants further study. Funding, Ethics, Regulatory Approvals and Registration: This study was funded by the UK Medical Research Council. All UK regulatory approvals were obtained. NCT01388504 and ISRCTN57596739.Author Disclosures: N. Siddiqi: None. M. Bruce: None. C.J. Neil: None. G. MacLennan: None. S. Cotton: None. S.A. Papadopoulou: None. B. Jagpal: None. S. Brown: None. F. Perez Gonzalez: None. S. Singh: None. K. Schwarz: None. M Feelisch: None. N. Bunce: None. P.O. Lim: None. D. Hildick-Smith: None. J. Horowitz: None. M. Madhani: None. N. Boon: None. J. Kaski: None. D. Dawson: None. M.P. Frenneaux: None.Key Words: Myocardial infarction, STEMI; Percutaneous coronary intervention; Reperfusion injury; Cardioprotection; Cardiac MRIBlood Pressure Reduction Among Acute Ischemic Stroke Patients: A Randomized Controlled Clinical TrialJiang He1, Yonghong Zhang2, Tan Xu2, Weijun Tong2, Shaoyan Zhang2, Chung-Shiuan Chen1, Qi Zhao1, Jing Chen1; 1Dept of Epidemiology, Tulane Univ, New Orleans, LA, 2Dept of Epidemiology, Soochow Univ, Suzhou, ChinaStroke is a major cause of death and disability globally. We conducted a randomized controlled trial to test the effect of blood pressure (BP) reduction on short-term case-fatality and major disability among patients with acute ischemic stroke in China. From August 2009 to May 2013, we recruited 4,071 patients with acute (within 48 hours of onset) ischemic stroke, with a systolic BP ≥140 mmHg. They were randomly assigned to antihypertensive treatment (lowering systolic BP by 10-25% within the first 24 hours after randomization and BP <140/90 mmHg within 7 days) or control (discontinuing all home antihypertensive medications). The primary outcome was a combination of death and major disability (defined by a modified Rankin scale ≥3) at 14 days or discharge and at 3 months. The secondary outcome was recurrent stroke, death, and vascular events during 3-months of follow-up. Mean systolic blood pressure was reduced from 166.7 mmHg to 144.7 (-12.7%) within 24 hours and to 135.2 by day 14 in the treatment group and from 165.6 mmHg to 152.9 (-7.2%) within 24 hours and to 143.7 by day 14 in the control group (p<0.0001 for group-differences). The primary outcome event rate was 33.6% in the treatment group and 33.6% in the control group (p=0.98) at 14 days or discharge. The primary outcome event rate was 25.2% in the treatment group and 25.3% in the control group (p=0.93) at 3 months. The event rates of recurrent stroke, vascular disease, and all-cause mortality were 1.4% and 2.2% (p=0.07), 2.4% and 3.0% (p=0.28), and 3.4% and 2.7% (p=0.20) in the treatment and control groups, respectively. In conclusion, this randomized trial indicates that antihypertensive treatment in patients with acute ischemic stroke within 48 hours of symptom onset does not reduce or increase death and major disability.Author Disclosures: J. He: None. Y. Zhang: None. T. Xu: None. W. Tong: None. S. Zhang: None. C. Chen: None. Q. Zhao: None. J. Chen: None.Key Words: Blood pressure; Antihypertensive agents; StrokeRandomized Clinical Trial of Pre-hospital Induction of Mild Hypothermia in Out-of-Hospital Cardiac Arrest Patients Using a Rapid Infusion of 4oC Normal SalineFrancis Kim1, Graham Nichol2, Charles Maynard3, Al Hallstrom2, Peter Kudenchuk1, Thomas Rea2, Michael Copass4, David Carlbom2, Steven Deem5, WT Longstreth4, Michele Olsufka2, Leonard Cobb1; 1Medicine/Cardiology, Univ of Washington, Seattle, WA, 2Medicine, Univ of Washington, Seattle, WA, 3Health Services, Univ of Washington, Seattle, WA, 4Neurology, Univ of Washington, Seattle, WA, 5Anesthesiology, Univ of Washington, Seattle, WABackground: In animal models of cardiac arrest, the benefit of therapeutic hypothermia declines when initiated more than 15 minutes after reperfusion. Although delayed hospital cooling has been demonstrated to improve outcome after cardiac arrest, pre-hospital cooling started immediately following return of spontaneous circulation may be more beneficial. The aims of this randomized clinical trial were to determine whether early in-field cooling improves survival and functional status in resuscitated cardiac arrest patients with ventricular fibrillation (VF) and without (non-VF). Methods: In a prospective, randomized clinical trial, we assigned adults with out-of-hospital cardiac arrest to either rapid pre-hospital cooling with an infusion of up to 2 liters of 4oC normal saline as soon as possible following resuscitation or to standard care. Nearly all of the resuscitated VF patients admitted to the hospital received hospital cooling regardless of their randomization. The primary outcome was survival to hospital discharge and functional status at discharge. Results: A total of 1359 patients (583 VF and 776 non-VF) were randomized to receive standard care with or without pre-hospital cooling. Among patients with VF, the intervention group had a mean core temperature decrease of 1.2 C +1.1 by hospital arrival, achieving a temperature of less than 34 C 1.3 hours sooner than the standard care group. Survival to hospital discharge was 62.5% in the intervention group vs. 64.3% in the control group, p=0.69. Among patients with non-VF, survival to discharge was 19.2% in the intervention group vs. 16.3% in the control group, p=0.3. Regardless of the initial rhythm, functional status at discharge was not significantly different between the treatment and control groups. The intervention was associated with increased incidence of re-arrest in the field (26% vs. 21%, p=0.007) as well as pulmonary edema on first chest x-ray and increased diuretic use, which all resolved within 12 hours after admission. Conclusions: Although use of early, pre-hospital cooling reduced core temperature by hospital arrival and reduced the time to reach 34 C, it did not improve survival or functional status among patients resuscitated from out-of-hospital VF or non-VF.Author Disclosures: F. Kim: None. G. Nichol: None. C. Maynard: None. A. Hallstrom: None. P. Kudenchuk: None. T. Rea: None. M. Copass: None. D. Carlbom: None. S. Deem: None. W. Longstreth: None. M. Olsufka: None. L. Cobb: None.Key Words: Cardiac arrest; Hypothermia; Ventricular fibrillationTarget Temperature Management 33°C versus 36°C after Out-of-hospital Cardiac Arrest, a Randomized, Parallel Group, Assessor Blinded Clinical TrialNiklas Nielsen1, Jørn Wetterslev2, Tobias Cronberg3, David Erlinge4, Yvan Gasche5, Christian Hassager6, Janneke Horn7, Jan Hovdenes8, Jesper Kjaergaard6, Michael Kuiper9, Tommaso Pellis10, Pascal Stammet11, Micahel Wanscher6, Matthew P Wise12, Anders Åneman13, Nawaf al-Subaie14, Søren Boesgaard6, Jon Bro-Jeppesen6, Iole Brunetti15, Jan F Bugge16, Christopher D Hingston12, Nicole Juffermans7, Matty Koopmans17, Lars Køber6, Jørund Langørgen18, Gisela Lilja3, Jakob E Møller6, Malin Rundgren19, Christian Rylander20, Ondrej Smid21, Christophe Werer22, Per Winkel2, Hans Friberg19; 1Dept of Anesthesiology and Intensive Care, Helsingborg Hosp, Lund Univ, Helsingborg, Sweden; 2Copenhagen Trial Unit, Copenhagen Univ Hosp, Copenhagen, Denmark; 3Dept of Neurology, Lund Univ Hosp, Lund, Sweden; 4Dept of Cardiology, Lund Univ Hosp, Lund, Sweden; 5Dept of Intensive Care, Geneve Univ Hosp, Geneve, Switzerland; 6Heart Cntr, Copenhagen Univ Hosp, Copenhagen, Denmark; 7Dept of Intensive Care, Academic Med Cntr, Amsterdam, Netherlands; 8Anesthesiology and Intensive Care, Oslo Univ Hosp, Oslo, Norway; 9Dept of Intensive Care, Leeuwarden Med Cntr, Leeuwarden, Netherlands; 10Dept of Intensive Care, Santa Maria degli Angeli Hosp, Pordenone, Italy; 11Dept of Intensive Care, Cntr Hospier de Luxembourg, Luxembourg, Luxembourg; 12Dept of Adult Critical Care, Univ Hosp of Wales, Cardiff, United Kingdom; 13Dept of Intensive Care, Liverpool Hosp, Liverpool, Sydney, Australia; 14Dept of Intensive Care, St George Hosp NHS Trust, Tooting, London, United Kingdom; 15Dept of Intensive Care, San Martino Hosp, Genoa, Italy; 16Dept of Anesthesiology and Intensive Care, Oslo Univ Hosp, Oslo, Norway; 17Dept of Intensive Care, Leeuwarden Med Cntr, leeuwarden, Netherlands; 18Dept of Cardiology, medical intensive care unit, Haukeland Univ Hosp, Bergen, Norway; 19Dept of Anesthesiology and Intensive Care, Lund Univ Hosp, Lund, Sweden; 20Dept of Anesthesiology and Intensive Care, Sahlgrenska Univ Hosp, Göteborg, Sweden; 21Critical Care Unit, General Univ Hosp in Prague, Prague, Czech Republic; 22Dept of Anesthesiology and Intensive Care, Cntr Hospier de Luxembourg, Luxembourg, LuxembourgIntroduction and objective: Unconscious patients with return of spontaneous circulation (ROSC) after out-of-hospital cardiac arrest (OHCA) have a high risk of death and poor neurological function. Temperature regulation is recommended in guidelines to improve outcome, but the optimal target temperature management strategy is not known. Our objective was to test two essentially different temperature levels, both avoiding hyperthermia, on the outcomes of survival and poor neurological function. Methods: In a multi-center, parallel-group, assessor blinded trial, conducted in 36 intensive care units, we centrally randomized 950 unconscious adults with ROSC after OHCA of presumed cardiac cause, to a target temperature management of 33°C or 36°C. The primary outcome is survival until end of trial (180 days after last randomization) adjusted for site as the stratification variable. The secondary outcomes are poor neurological function or death at 180 days and adverse events (bleeding, infection, arrhythmia, electrolyte- and metabolic disturbances) within the first seven days. Secondary multi-variate analyses will be performed adjusting for age, gender, initial rhythm, time to ROSC and presence of shock at admission. Results: Nine hundred and fifty patients were randomized between November 2010 and January 2013. The cohort baseline characteristics are: median age 65 years (inter quartile range 56-73), 81 % male gender, and 78 % ventricular fibrillation or non-perfusing tachycardia. The last follow up will be performed in July 2013. Data on demographics, temperature and critical care management, primary outcome (survival) and secondary outcomes (neurological function and adverse events) will be presented. Conclusion: The target temperature management 33°C versus 36°C after out-of-hospital cardiac arrest-trial is the largest trial to date investigating target temperature management after cardiac arrest. Results will be available end of August. (NCT01020916)Author Disclosures: N. Nielsen: None. J. Wetterslev: None. T. Cronberg: None. D. Erlinge: None. Y. Gasche: None. C. Hassager: None. J. Horn: None. J. Hovdenes: None. J. Kjaergaard: None. M. Kuiper: None. T. Pellis: None. P. Stammet: None. M. Wanscher: None. M.P. Wise: None. A. Åneman: None. N. al-Subaie: None. S. Boesgaard: None. J. Bro-Jeppesen: None. I. Brunetti: None. J.F. Bugge: None. C.D. Hingston: None. N. Juffermans: None. M. Koopmans: None. L. Køber: None. J. Langørgen: None. G. Lilja: None. J.E. Møller: None. M. Rundgren: None. C. Rylander: None. O. Smid: None. C. Werer: None. P. Winkel: None. H. Friberg: None.Key Words: Cardiac arrest; Hypothermia; OutcomesLate-Breaking Clinical Trials: Prevention: From Schools to CountriesPromotion of Cardiovascular Health in Preschool Children: 36-month Cohort Follow-upJaime Céspedes1, German Briceño1, Michael Farkouh2, Rajesh Vedanthan3, Jorge Baxter4, Martha Leal1, Paolo Boffetta3, Marilyn Hunn3, Rodolfo Dennis5, Valentin Fuster6; 1Pediatría, Fundación CardioInfantil Instituto de Cardiología, Bogotá, Colombia; 2Cardiology, Icahn Sch of Medicine at Mount Sinai; Peter Munk Cardiac Cntr and Li Ka Shing Knowledge Institute, Univ of Toronto, Toronto, Canada; 3Cardiology, Icahn Sch of Medicine at Mount Sinai, New York, NY, 4Global Education, Sesame Workshop, New York, NY, 5Investigaciones, Fundación CardioInfantil Instituto de Cardiología, Bogotá, Colombia; 6Cardiology, Icahn Sch of Medicine at Mount Sinai; Cntr Nacional de Investigaciones Cardiovasculares, New York, NYBackground: Educational interventions in preschool children could improve dietary behavior and physical activity, and prevent unhealthy body weights in low- and middle- income countries. We have previously reported the beneficial impact of an educational intervention in preschoolers in a six month trial. We now report extended results after 36 months. Methods: Evaluating the cohort of previously intervened children, baseline measurements were made in May 2009 in 14 preschool facilities in Usaquén (Bogotá, Colombia). Follow-up measurements were performed at 18 and 36 months. The primary outcome was the mean change in children's knowledge and attitudes scores regarding healthy eating and living an active lifestyle, including habits scores related to physical activity. Secondary outcomes were the change over time of children's nutritional status and the mean change in parent's knowledge, attitudes and habits. RESULTS: We included 1,216 children, 3-5 years of age, and 928 parents. After adjusting by sex and age of children, socioeconomic status, age of parents, age and education level of teachers, we found a significant increase in mean knowledge, attitudes and habits scores at 36 months, compared to baseline: 87.94 vs. 76.15 (p<0.001); 86.39 vs. 57.03 (p<0.001); and 66.29 vs. 48.72 (p<0.001) respectively. We observed a similar increase in knowledge and attitude scores in parents:73.45 vs. 70.01 (p<0.001); and 78.08 vs. 74.65(p<0.001). The proportion of eutrophic children increased from 62.1% at baseline to 75.0% at 36 months (p<0.0001). Conclusions: After 36 months, the educational intervention maintained a beneficial trend towards a healthy lifestyle in children and their parents. Key Words: Cardiovascular disease prevention • Nutrition • Physical activityAuthor Disclosures: J. Céspedes: None. G. Briceño: None. M. Farkouh: None. R. Vedanthan: None. J. Baxter: None. M. Leal: None. P. Boffetta: None. M. Hunn: None. R. Dennis: None. V. Fuster: None.Key Words: Health promotion; Health education; Cardiovascular disease prevention; Behavior change; Community-based careRandomized Trial of Social Network Lifestyle Intervention for Obesity: MICROCLINIC Intervention Results and 16-Month Follow-upEric L Ding1, Kathleen T Watson2, Nancy Bui2, Leila Makarechi2, Leslie Lang2, Marta R Prescott2, Sha'Tia N Safford3, Dipti Banerjee3, Harold W Campbell4, Josh A Rushakoff4, Daniel E Zoughbie3; 1Dept of Nutrition, Harvard Sch of Public Health, Boston, MA, 2MCI Rsch Div, Microclinic International, San Francisco, CA, 3Executive office, Microclinic International, San Francisco, CA, 4Executive Office, Microclinic International, San Francisco, CABACKGROUND: Obesity has been suggested to propagate within social networks. A social network program was engineered to contagiously propagate healthy lifestyles and leverage pre-existing social networks to decrease obesity. We expand upon a 9- to 10-month intervention program with 16 month followup to investigate the power of social networks in the first ever long-term randomized trial. METHODS: Based in rural Appalachian region of Kentucky, we investigate the Microclinic Social Network Behavioral Health Invervention (MSN) lifestyle intervention in a resource-limited but socially cohesive area with high obesity prevalence. Social clusters of 2-8 individuals who participated together in a program with weekly physical activity, nutrition, health education and social activity sessions led by health-educators; controls had access to standard care from local county health department. Body weight and waist circumference were collected in followup waves during intervention, plus at 16 months after baseline in a 52% sample subcohort. Longitudinal analyses utilized multilevel repeated-measures mixed models, with multilevels of neighborhood center, classroom, and social cluster (i.e. microclinic) to examine the change in health outcomes in program participants vs. controls. RESULTS: Study enrolled 552 participants, comprised of 242 social clusters, among 27 classroom clusters, and from 5 neighborhood cohorts. Participants were 85.8% women, mean age 50.9 years (13.8), mean BMI 36.2 (7.6). From baseline to end of intervention period, MSN intervention group showed decreased body weight of -6.52 lbs (95% CI: -8.57 to -4.47; P<0.001), and improved central adiposity with decreased waist circumference of -1.24 inches (-1.85 to -0.63; P 0.80 in the year after hospital discharge using pharmacy refill data for clopidogrel, beta-blockers, HMG CoA reductase inhibitors (statins), and angiotensin converting enzyme inhibitor (ACE)/angiotensin receptor blocker (ARB)). Secondary outcomes included achievement of blood pressure and low-density lipoprotein cholesterol targets. Results: Of 253 patients, 241 (95%) completed the study (122 in INT and 119 in UC). In the intervention group, 89.3% of patients were adherent compared to 73.9% in UC group (p=0.003). Mean PDC was higher in INT as well (0.94 vs. 0.87; INT vs. UC p=<0.001). A greater proportion of intervention patients were adherent to clopidogrel (87% vs. 71%; p=0.03), statins (93% vs. 82%; p<0.001), and ACE/ARB (93% vs. 82%; p=0.03) but not for beta-blockers (88% vs. 85%; p=0.59). There were no differences in achievement of BP and LDL goals. Conclusions and Relevance: A multifaceted intervention comprised of pharmacist-led medication reconciliation and tailoring, patient education, collaborative care between pharmacist and primary care provider/cardiologist, and voice messaging improved adherence to cardiac medications in the year after ACS hospital discharge. These findings may provide a framework to improve medication adherence.Author Disclosures: M. Ho: None. A. Lambert-Kerzner: None. E. Carey: None. I. Fahdi: None. C. Bryson: None. D.S. Melnyk: None. H. Bosworth: None. T. Radcliff: None. C. Barnett: None. R. Davis: None. H. Mun: None. J. Weaver: None. E. Del Giacco: None.Key Words: Adherence; Behavioral medicine; Outcomes; Acute coronary syndromesChina Rural Health Initiative - Sodium Reduction Study: the Effects of a Community-Based Sodium Reduction Program on 24hr Urinary Sodium and Blood Pressure in Rural ChinaNicole Li1, Lijing Yan2, Wenyi Niu3, Chen Yao4, Xiangxian Feng5, Jianxin Zhang6, Jingpu Shi7, Yuhong Zhang8, Ruijuan Zhang9, Zhixin Hao2, Hongling Chu4, Jing Zhang10, Xian Li11, Zhifang Li12, Jixin Sun13, Bo Zhou7, Yi Zhao8, Yan Yu9, Darwin Labarthe14, Jixiang Ma15, Elizabeth Delong16, Paul Elliott17, Stephen MacMahon18, Yangfeng Wu19, Bruce Neal20; 1Food Policy, The George Institute for Global Health, Sydney, Australia; 2Rsch and Development, The George Institute for Global Health, China, Beijing, China; 3Sch of Public Health, Peking Univ Health Science Cntr, Beijing, China; 4Peking Univ Clinical Rsch Institute, Peking Univ Health Science Cntr, Beijing, China; 5Changzhi Med College, Changzhi Med College, Changzhi, China; 6Head Office, Hebei Province Cntr for Disease Prevention and Control, Shijiazhuang, China; 7Sch of Public Health, China Med Univ, Shenyang, China; 8Sch of Public Health, Ningxia Med Univ, Yinchuan, China; 9Dept of Public Health, Xi'an Jiaotong Univ, Xi'an, China; 10Rsch and Development, The George Institute for Global Health, China, Beijing, China; 11Data Management, The George Institute for Global Health, China, Beijing, China; 12Dept of Preventive Medicine, Changzhi Med College, Changzhi, China; 13Institute for Chronic Disease Prevention and Control, Hebei Province Cntr for Disease Prevention and Control, Shijiazhuang, China; 14Dept of Preventive Medicine, Northwestern Univ, Chicago, IL, 15Cntr for Chronic Disease Prevention and Control, Chinese Cntr for Disease Control and Prevention, Beijing, China; 16Sch of Medicine, Duke Univ, Durham, NC, 17Sch of Public Health, Imperial College Faculty of Medicine, London, Australia; 18Principal Director's Office, The George Institute for Global Health, Sydney, Australia; 19Executive Director, The George Institute for Global Health, China, Beijing, China; 20Senior Director, The George Institute for Global Health, Sydney, AustraliaBackground: Cardiovascular diseases are the leading cause of death in rural China. High blood pressure caused by excessive sodium consumption has been identified as an important modifiable risk factor. An effective low cost population-based strategy to reduce sodium intake in rural China has significant public health potential. Methods: The study is a large-scale, cluster-randomized trial done in five Northern provinces in China. Two counties have been selected from each province and 12 townships enrolled from each county making a total of 120 clusters. One village from each township was selected for participation and randomized to intervention or control with stratification by county. The 60 control group villages received no intervention and simply continued with their usual practices. The 60 intervention villages received general community health education advising reduced salt intake, specific health education targeting salt reduction messages to patients at high risk of cardiovascular diseases, and a food supply strategy designed to promote the sale of a reduced sodium added potassium salt substitute through the village convenience stores. The 60 intervention villages were further randomised into two equal groups, such that 30 villages had access to salt substitute at a price parity with normal salt and 30 had salt substitute available at market price (about twice the cost of normal salt). The intervention was implemented for 18 months. An age- and sex-stratified random sample of 2400 men and women from the 120 villages (20 from each village) were selected at the end of the intervention period for outcome evaluation. The primary outcome is 24-hour urinary sodium and secondary outcomes are blood pressure, 24 hour urinary potassium, urinary sodium:potassium ratio and the proportion with hypertension. Results Data have been collected as planned and are currently being analyzed. Results for the primary and secondary outcome measures will be reported. Conclusions: The study has successfully completed the implementation and evaluation of a novel, practical, scalable strategy for vascular disease prevention in rural China. The findings will have significant implications for health policy.Author Disclosures: N. Li: None. L. Yan: None. W. Niu: None. C. Yao: None. X. Feng: None. J. Zhang: None. J. Shi: None. Y. Zhang: None. R. Zhang: None. Z. Hao: None. H. Chu: None. J. Zhang: None. X. Li: None. Z. Li: None. J. Sun: None. B. Zhou: None. Y. Zhao: None. Y. Yu: None. D. Labarthe: None. J. Ma: None. E. Delong: None. P. Elliott: None. S. MacMahon: None. Y. Wu: None. B. Neal: None.Key Words: Community-based care; Health education; Blood pressure; Sodium; Cardiovascular disease preventionLate-Breaking Clinical Trials: Medical and Surgical Approaches to Improving Heart Failure OutcomesAtrial Antitachycardia Pacing and Managed Ventricular Pacing Reduce the Endpoint Composed by Death, Cardiovascular Hospitalizations and Permanent Atrial Fibrillation Compared to Conventional Dual Chamber Pacing in Bradycardia Patients: Results of the Minerva Randomized StudyGiuseppe Boriani1, Raymond Tukkie2, Lluis Mont3, Helmut Pürerfellner4, Antonis S Manolis5, Massimo Santini6, Giuseppe Inama7, Paolo Serra8, Silvia Parlanti9, Lorenza Mangoni9
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