27 research outputs found

    Effects of Renal Denervation vs Sham in Resistant Hypertension after Medication Escalation:Prespecified Analysis at 6 Months of the RADIANCE-HTN TRIO Randomized Clinical Trial

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    IMPORTANCE: Although early trials of endovascular renal denervation (RDN) for patients with resistant hypertension (RHTN) reported inconsistent results, ultrasound RDN (uRDN) was found to decrease blood pressure (BP) vs sham at 2 months in patients with RHTN taking stable background medications in the Study of the ReCor Medical Paradise System in Clinical Hypertension (RADIANCE-HTN TRIO) trial. OBJECTIVES: To report the prespecified analysis of the persistence of the BP effects and safety of uRDN vs sham at 6 months in conjunction with escalating antihypertensive medications. DESIGN, SETTING, AND PARTICIPANTS: This randomized, sham-controlled, clinical trial with outcome assessors and patients blinded to treatment assignment, enrolled patients from March 11, 2016, to March 13, 2020. This was an international, multicenter study conducted in the US and Europe. Participants with daytime ambulatory BP of 135/85 mm Hg or higher after 4 weeks of single-pill triple-combination treatment (angiotensin-receptor blocker, calcium channel blocker, and thiazide diuretic) with estimated glomerular filtration rate (eGFR) of 40 mL/min/1.73 m(2 )or greater were randomly assigned to uRDN or sham with medications unchanged through 2 months. From 2 to 5 months, if monthly home BP was 135/85 mm Hg or higher, standardized stepped-care antihypertensive treatment starting with aldosterone antagonists was initiated under blinding to treatment assignment. INTERVENTIONS: uRDN vs sham procedure in conjunction with added medications to target BP control. MAIN OUTCOMES AND MEASURES: Six-month change in medications, change in daytime ambulatory systolic BP, change in home systolic BP adjusted for baseline BP and medications, and safety. RESULTS: A total of 65 of 69 participants in the uRDN group and 64 of 67 participants in the sham group (mean [SD] age, 52.4 [8.3] years; 104 male [80.6%]) with a mean (SD) eGFR of 81.5 (22.8) mL/min/1.73 m(2) had 6-month daytime ambulatory BP measurements. Fewer medications were added in the uRDN group (mean [SD], 0.7 [1.0] medications) vs sham (mean [SD], 1.1 [1.1] medications; P = .045) and fewer patients in the uRDN group received aldosterone antagonists at 6 months (26 of 65 [40.0%] vs 39 of 64 [60.9%]; P = .02). Despite less intensive standardized stepped-care antihypertensive treatment, mean (SD) daytime ambulatory BP at 6 months was 138.3 (15.1) mm Hg with uRDN vs 139.0 (14.3) mm Hg with sham (additional decreases of −2.4 [16.6] vs −7.0 [16.7] mm Hg from month 2, respectively), whereas home SBP was lowered to a greater extent with uRDN by 4.3 mm Hg (95% CI, 0.5-8.1 mm Hg; P = .03) in a mixed model adjusting for baseline and number of medications. Adverse events were infrequent and similar between groups. CONCLUSIONS AND RELEVANCE: In this study, in patients with RHTN initially randomly assigned to uRDN or a sham procedure and who had persistent elevation of BP at 2 months after the procedure, standardized stepped-care antihypertensive treatment escalation resulted in similar BP reduction in both groups at 6 months, with fewer additional medications required in the uRDN group. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT0264942

    Extension's Dining with Diabetes: Helping People Prevent and Manage Diabetes in Ohio and throughout the Nation

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    Diabetes is a common, serious and expensive disease in Ohio, the United States and around the world. The complications of untreated or undertreated diabetes are devastating and include heart, kidney, eye and nerve diseases. Studies have shown that when blood glucose is controlled, complications of diabetes are delayed or possibly prevented. Extension's Dining with Diabetes (DWD) program is designed for people with diabetes, their family members and those at risk; and it consists of education, cooking demonstrations, and taste testing. Participants are engaged on the topics of healthy cooking strategies, meal planning, portion control, label reading, physical activity, and goal setting. The program is delivered as a series of four face-to-face sessions with a three-month reunion led by Extension educators partnering with registered nurses, certified diabetes educators or registered dietatians. In addition to Extension offices, local community centers, faith-based organizations, libraries and hospitals are often used as locations in which to offer the program. State and local health departments, clinics, hospitals, pharmacies and community health coalitions are active in marketing the program. DWD has been implemented in Ohio for more than a decade, and is now a national program with more than 38 states participating. Dining with Diabetes has a successful history of being implemented in Ohio and adapted by other states. The national program and evaluation provides the opportunity to demonstrate national impact and how Ohio's efforts compare with other states in terms of improving diabetes outcomes. The national program evaluation includes assessment of knowledge, attitudes and skill gains related to diabetes management. Medium-term outcomes include reported behavior change in the areas of food selection, food preparation, label reading, and physical activity. Participants who reported at three months follow-up demonstrated the ability to maintain or improve dietary change after completing the program.AUTHOR AFFILIATION: Dan Remley, Field Specialist, Food, Nutrition and Wellness, The Ohio State University Extension, [email protected] (Corresponding Author); Shari Gallup, Educator, Family and Consumer Sciences, The Ohio State University Extension; Margaret Jenkins, Educator, Family and Consumer Sciences, The Ohio State University Extension; Tammy Jones, Educator, Family and Consumer Sciences, The Ohio State University Extension; Jenny Lobb, Educator, Family and Consumer Sciences, The Ohio State University Extension; Susan Zies, Educator, Family and Consumer Sciences, The Ohio State University Extension; Marie Economos, Educator, Family and Consumer Sciences, The Ohio State University Extension; Chris Kendle, Educator, Family and Consumer Sciences, The Ohio State University Extension; Chelsea Peckny, Assistant Professor, College of Pharmacy; Joyce Riley, Educator, Family and Consumer Sciences, The Ohio State University Extension; Amy Meehan, Healthy People Program Specialist; Brian Butler, Evaluation Specialist, The Ohio State University Extension; Ingrid Adams, Associate Professor; Lisa Barlage, Educator, Family and Consumer Sciences, The Ohio State University Extension; Candace Heer, Associate Professor; Amanda Bohlen, Educator, Family and Consumer Sciences, The Ohio State University Extension.Diabetes is a common, serious and expensive disease in Ohio, the United States and around the world. The complications of untreated or undertreated diabetes are devastating and include heart, kidney, eye and nerve diseases. Extension's Dining with Diabetes (DWD) program engages participants on the topics of healthy cooking strategies, meal planning, portion control, label reading, physical activity, and goal setting. The program is delivered as a series of four face-to-face sessions with a three-month reunion led by Extension educators partnering with registered nurses, certified diabetes educators or registered dietitians. DWD has a national curricula and evaluation, providing the opportunity to demonstrate national and state-level impact on knowledge, attitudes and skills related to diabetes management

    Integrated genomic characterization of pancreatic ductal adenocarcinoma

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    We performed integrated genomic, transcriptomic, and proteomic profiling of 150 pancreatic ductal adenocarcinoma (PDAC) specimens, including samples with characteristic low neoplastic cellularity. Deep whole-exome sequencing revealed recurrent somatic mutations in KRAS, TP53, CDKN2A, SMAD4, RNF43, ARID1A, TGFβR2, GNAS, RREB1, and PBRM1. KRAS wild-type tumors harbored alterations in other oncogenic drivers, including GNAS, BRAF, CTNNB1, and additional RAS pathway genes. A subset of tumors harbored multiple KRAS mutations, with some showing evidence of biallelic mutations. Protein profiling identified a favorable prognosis subset with low epithelial-mesenchymal transition and high MTOR pathway scores. Associations of non-coding RNAs with tumor-specific mRNA subtypes were also identified. Our integrated multi-platform analysis reveals a complex molecular landscape of PDAC and provides a roadmap for precision medicine
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