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Your search keyword '"Cheryl Laffer"' showing total 2 results
Start Over Author "Cheryl Laffer" Topic 030204 cardiovascular system & hematology
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1. Ultrasound renal denervation for hypertension resistant to a triple medication pill (RADIANCE-HTN TRIO): a randomised, multicentre, single-blind, sham-controlled trial

Author

Michel Azizi, Kintur Sanghvi, Manish Saxena, Philippe Gosse, John P Reilly, Terry Levy, Lars C Rump, Alexandre Persu, Jan Basile, Michael J Bloch, Joost Daemen, Melvin D Lobo, Felix Mahfoud, Roland E Schmieder, Andrew S P Sharp, Michael A Weber, Marc Sapoval, Pete Fong, Atul Pathak, Pierre Lantelme, David Hsi, Sripal Bangalore, Adam Witkowski, Joachim Weil, Benjamin Kably, Neil C Barman, Helen Reeve-Stoffer, Leslie Coleman, Candace K McClure, Ajay J Kirtane, Josh Costello, Courtney Krathan, Luot Lewis, Andrew McElvarr, John Reilly, Stephen Jenkins, Michael Cash, Shannon Williams, Maria Jarvis, Cheryl Laffer, James Gainer, Mark Robbins, Sherron Crook, Sarita Maddel, Scott Martin, Edward Portnay, Maryanne Ducey, Suzanne Rose, Elizabeth DelMastro, Stephen Williams, Stanley Cabos, Carolina Rodriguez Alvarez, Thomas Todoran, Eric Powers, Emily Hodskins, Vijay Paladugu, Anna Tecklenburg, Chandan Devireddy, Janice Lea, Bryan Wells, Amanda Fiebach, Claudia Merlin, Florian Rader, Suhail Dohad, Hyun-Min Kim, Mohammad Rashid, Josephine Abraham, Theophilus Owan, Anu Abraham, Iran Lavasani, Hailey Neilson, David Calhoun, Thomas McElderry, William Maddox, Suzanne Oparil, Sheila Kinder, Jai Radhakrishnan, Candido Batres, Suzanne Edwards, Joseph Garasic, Doug Drachman, Randy Zusman, Kenneth Rosenfield, Danny Do, Matheen Khuddus, Suzanne Zentko, James O'Meara, Ilie Barb, Abby Foster, Alice Boyette, Yale Wang, Desmond Jay, Nedaa Skeik, Robert Schwartz, Rose Peterson, Jo Anne Goldman, Jessie Goldman, Gary Ledley, Nancy Katof, Srinivasa Potluri, Scott Biedermann, Jacquelyn Ward, Megan White, Naomi DL Fisher, Laura Mauri, Piotr Sobieszczky, Alex Smith, Laura Aseltine, Rick Stouffer, Alan Hinderliter, Eric Pauley, Tyrone Wade, David Zidar, Mehdi Shishehbor, Barry Effron, Marco Costa, Terence Semenec, Chanwit Roongsritong, Priscilla Nelson, Bridget Neumann, Debbie Cohen, Jay Giri, Robin Neubauer, Thu Vo, Atul R Chugh, Pei-Hsiu Huang, Powell Jose, John Flack, Robert Fishman, Michael Jones, Todd Adams, Christopher Bajzer, Anthony Mathur, Ajay Jain, Armida Balawon, Olivier Zongo, Clare Bent, David Beckett, Nicki Lakeman, Sarah Kennard, Andrew Sharp, Richard J D'Souza, Sarah Statton, Lindsay Wilkes, Christine Anning, Jeremy Sayer, Sudha Ganesh Iyer, Nicholas Robinson, Annaliza Sevillano, Madelaine Ocampo, Robert Gerber, Mohamad Faris, Andrew John Marshall, Janet Sinclair, Hayley Pepper, Justin Davies, Neil Chapman, Paula Burak, Paula Carvelli, Sachin Jadhav, Jane Quinn, Lars Christian Rump, Johannes Stegbauer, Lars Schimmöller, Sebastian Potthoff, Claudia Schmid, Sylvia Roeder, Lukas Hafer, Tolga Agdirlioglu, Tanja Köllner, Michael Böhm, Sebastian Ewen, Saarraaken Kulenthiran, Angelika Wachter, Christina Koch, Philipp Lurz, Karl Fengler, Karl-Philipp Rommel, Kai Trautmann, Martin Petzold, Christian Ott, Axel Schmid, Michael Uder, Ulrike Heinritz, Kerstin Fröhlich-Endres, Sabine Genth-Zotz, Denise Kämpfner, Armin Grawe, Johannes Höhne, Bärbel Kaesberger, Constantin von zur Mühlen, Dennis Wolf, Markus Welzel, Gudrun Heinrichs, Barbara Trabitzsch, Antoine Cremer, Hervé Trillaud, Panteleimon Papadopoulos, Florent Maire, Julie Gaudissard, Erika Cornu, David Fouassier, Marine Livrozet, Aurélien Lorthioir, Valérie Paquet, Benjamin Honton, Marianne Cottin, Frédéric Petit, Constance Berge, Pierre-Yves Courand, Fatou Langevin, Pascal Delsart, Benjamin Longere, Guillaume Ledieu, François Pontana, Coralie Sommeville, Fabien Bertrand, Lida Feyz, Victor Zeijen, Arno Ruiter, Elisabeth Huysken, Peter Blankestijn, Michiel Voskuil, Zwaantina Rittersma, Helma Dolmans, A A Kroon, W H van Zwam, Jeannique Vranken, Claudia de Haan, Jean Renkin, Frédéric Maes, Christophe Beauloye, Jean-Philippe Lengelé, Dominique Huyberechts, Anne Bouvie, Andrzej Januszewicz, Jacek Kdziela, Aleksander Prejbisj, Dagmara Hering, Dariusz Ciecwierz, Milosz J Jaguszewski, Radoslaw Owczuk, RS: Carim - V02 Hypertension and target organ damage, MUMC+: MA Alg Interne Geneeskunde (9), Interne Geneeskunde, RS: Carim - B06 Imaging, RS: Carim - B05 Cerebral small vessel disease, Beeldvorming, MUMC+: DA BV Medisch Specialisten Radiologie (9), RS: CARIM School for Cardiovascular Diseases, and Cardiology

Subjects
Male, Ambulatory blood pressure, medicine.drug_class, medicine.medical_treatment, Sodium Chloride Symporter Inhibitors, Population, Drug Resistance, Calcium channel blocker, 030204 cardiovascular system & hematology, Kidney, law.invention, 03 medical and health sciences, Angiotensin Receptor Antagonists, 0302 clinical medicine, Renal Artery, ADHERENCE, Randomized controlled trial, law, Ultrasonic Surgical Procedures, medicine, Humans, Single-Blind Method, 030212 general & internal medicine, education, Denervation, education.field_of_study, PLACEBO, business.industry, Endovascular Procedures, General Medicine, Blood Pressure Monitoring, Ambulatory, Middle Aged, Calcium Channel Blockers, Blood pressure, Anesthesia, Ambulatory, Hypertension, Female, Diuretic, business
Abstract

Summary Background Endovascular renal denervation reduces blood pressure in patients with mild-to-moderate hypertension, but its efficacy in patients with true resistant hypertension has not been shown. We aimed to assess the efficacy and safety of endovascular ultrasound renal denervation in patients with hypertension resistant to three or more antihypertensive medications. Methods In a randomised, international, multicentre, single-blind, sham-controlled trial done at 28 tertiary centres in the USA and 25 in Europe, we included patients aged 18–75 years with office blood pressure of at least 140/90 mm Hg despite three or more antihypertensive medications including a diuretic. Eligible patients were switched to a once daily, fixed-dose, single-pill combination of a calcium channel blocker, an angiotensin receptor blocker, and a thiazide diuretic. After 4 weeks of standardised therapy, patients with daytime ambulatory blood pressure of at least 135/85 mm Hg were randomly assigned (1:1) by computer (stratified by centres) to ultrasound renal denervation or a sham procedure. Patients and outcome assessors were masked to randomisation. Addition of antihypertensive medications was allowed if specified blood pressure thresholds were exceeded. The primary endpoint was the change in daytime ambulatory systolic blood pressure at 2 months in the intention-to-treat population. Safety was also assessed in the intention-to-treat population. This study is registered with ClinicalTrials.gov , NCT02649426 . Findings Between March 11, 2016, and March 13, 2020, 989 participants were enrolled and 136 were randomly assigned to renal denervation (n=69) or a sham procedure (n=67). Full adherence to the combination medications at 2 months among patients with urine samples was similar in both groups (42 [82%] of 51 in the renal denervation group vs 47 [82%] of 57 in the sham procedure group; p=0·99). Renal denervation reduced daytime ambulatory systolic blood pressure more than the sham procedure (−8·0 mm Hg [IQR –16·4 to 0·0] vs –3·0 mm Hg [–10·3 to 1·8]; median between-group difference –4·5 mm Hg [95% CI –8·5 to –0·3]; adjusted p=0·022); the median between-group difference was –5·8 mm Hg (95% CI –9·7 to –1·6; adjusted p=0·0051) among patients with complete ambulatory blood pressure data. There were no differences in safety outcomes between the two groups. Interpretation Compared with a sham procedure, ultrasound renal denervation reduced blood pressure at 2 months in patients with hypertension resistant to a standardised triple combination pill. If the blood pressure lowering effect and safety of renal denervation are maintained in the long term, renal denervation might be an alternative to the addition of further antihypertensive medications in patients with resistant hypertension. Funding ReCor Medical.

Published
2021

2. Endovascular ultrasound renal denervation to treat hypertension (RADIANCE-HTN SOLO): a multicentre, international, single-blind, randomised, sham-controlled trial

Author

Michel Azizi, Roland E Schmieder, Felix Mahfoud, Michael A Weber, Joost Daemen, Justin Davies, Jan Basile, Ajay J Kirtane, Yale Wang, Melvin D Lobo, Manish Saxena, Lida Feyz, Florian Rader, Philipp Lurz, Jeremy Sayer, Marc Sapoval, Terry Levy, Kintur Sanghvi, Josephine Abraham, Andrew S P Sharp, Naomi D L Fisher, Michael J Bloch, Helen Reeve-Stoffer, Leslie Coleman, Christopher Mullin, Laura Mauri, Desmond Jay, Nedaa Skeik, Robert Schwartz, Suhail Dohad, Ronald Victor, Josh Costello, Courtney Walsh, Theophilus Owan, Anu Abraham, Naomi D.L. Fisher, Piotr Sobieszczky, Jonathan Williams, Michael J. Bloch, Chanwit Roongsritong, Thomas Todoran, Eric Powers, Emily Hodskins, Pete Fong, Cheryl Laffer, James Gainer, Mark Robbins, John P. Reilly, Michael Cash, Jessie Goldman, Sandeep Aggarwal, Gary Ledley, David Hsi, Scott Martin, Edward Portnay, David Calhoun, Thomas McElderry, William Maddox, Suzanne Oparil, Pei-Hsiu Huang, Powell Jose, Matheen Khuddus, Suzanne Zentko, James O'Meara, Ilie Barb, Joseph Garasic, Doug Drachman, Randy Zusman, Kenneth Rosenfield, Chandan Devireddy, Janice Lea, Bryan Wells, Rick Stouffer, Alan Hinderliter, Eric Pauley, Srinivasa Potluri, Scott Biedermann, Sripal Bangalore, Stephen Williams, David Zidar, Mehdi Shishehbor, Barry Effron, Marco Costa, Ajay J. Kirtane, Jai Radhakrishnan, Melvin D. Lobo, Anthony Mathur, Ajay Jain, Sudha Ganesh Iyer, Nicholas Robinson, Sadat Ali Edroos, Amit Patel, David Beckett, Clare Bent, Neil Chapman, Matthew Shun-Shin, James Howard, Andrew S.P. Sharp, Anil Joseph, Richard D'Souza, Robert Gerber, Mohamad Faris, Andrew J. Marshall, Cristina Elorz, Robert Höllriegel, Karl Fengler, Karl-Philipp Rommel, Michael Böhm, Sebastian Ewen, Jelena Lucic, Roland E. Schmieder, Christian Ott, Axel Schmid, Michael Uder, L. Christian Rump, Johannes Stegbauer, Patric Kröpil, Erika Cornu, David Fouassier, Philippe Gosse, Antoine Cremer, Hervé Trillaud, Panteleimon Papadopoulos, Atul Pathak, Benjamin Honton, Pierre Lantelme, Constance Berge, Pierre-Yves Courand, Peter J. Blankestijn, Michiel Voskuil, Zwaantina Rittersma, A.A. Kroon, W.H. van Zwam, Alexandre Persu, Jean Renkin, Université Claude Bernard Lyon 1 (UCBL), Université de Lyon, Centre de Recherche en Acquisition et Traitement de l'Image pour la Santé (CREATIS), Université Jean Monnet [Saint-Étienne] (UJM)-Hospices Civils de Lyon (HCL)-Institut National des Sciences Appliquées de Lyon (INSA Lyon), Université de Lyon-Institut National des Sciences Appliquées (INSA)-Université de Lyon-Institut National des Sciences Appliquées (INSA)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM), and Cardiology

Subjects
Adult, Male, Ambulatory blood pressure, Adolescent, [SDV]Life Sciences [q-bio], Population, 030204 cardiovascular system & hematology, Renal artery stenosis, Kidney, 03 medical and health sciences, Young Adult, 0302 clinical medicine, Renal Artery, medicine.artery, medicine, Humans, Single-Blind Method, 030212 general & internal medicine, Kidney surgery, Renal artery, education, ComputingMilieux_MISCELLANEOUS, Aged, Ultrasonography, Denervation, education.field_of_study, business.industry, Endovascular Procedures, General Medicine, Blood Pressure Monitoring, Ambulatory, Middle Aged, medicine.disease, 3. Good health, Blood pressure, Treatment Outcome, Editorial, Anesthesia, Ambulatory, Hypertension, Female, business
Abstract

Summary Background Early studies suggest that radiofrequency-based renal denervation reduces blood pressure in patients with moderate hypertension. We investigated whether an alternative technology using endovascular ultrasound renal denervation reduces ambulatory blood pressure in patients with hypertension in the absence of antihypertensive medications. Methods RADIANCE-HTN SOLO was a multicentre, international, single-blind, randomised, sham-controlled trial done at 21 centres in the USA and 18 in Europe. Patients with combined systolic–diastolic hypertension aged 18–75 years were eligible if they had ambulatory blood pressure greater than or equal to 135/85 mm Hg and less than 170/105 mm Hg after a 4-week discontinuation of up to two antihypertensive medications and had suitable renal artery anatomy. Patients were randomised (1:1) to undergo renal denervation with the Paradise system (ReCor Medical, Palo Alto, CA, USA) or a sham procedure consisting of renal angiography only. The randomisation sequence was computer generated and stratified by centres with randomised blocks of four or six and permutation of treatments within each block. Patients and outcome assessors were blinded to randomisation. The primary effectiveness endpoint was the change in daytime ambulatory systolic blood pressure at 2 months in the intention-to-treat population. Patients were to remain off antihypertensive medications throughout the 2 months of follow-up unless specified blood pressure criteria were exceeded. Major adverse events included all-cause mortality, renal failure, an embolic event with end-organ damage, renal artery or other major vascular complications requiring intervention, or admission to hospital for hypertensive crisis within 30 days and new renal artery stenosis within 6 months. This study is registered with ClinicalTrials.gov, number NCT02649426. Findings Between March 28, 2016, and Dec 28, 2017, 803 patients were screened for eligibility and 146 were randomised to undergo renal denervation (n=74) or a sham procedure (n=72). The reduction in daytime ambulatory systolic blood pressure was greater with renal denervation (−8·5 mm Hg, SD 9·3) than with the sham procedure (−2·2 mm Hg, SD 10·0; baseline-adjusted difference between groups: −6·3 mm Hg, 95% CI −9·4 to −3·1, p=0·0001). No major adverse events were reported in either group. Interpretation Compared with a sham procedure, endovascular ultrasound renal denervation reduced ambulatory blood pressure at 2 months in patients with combined systolic–diastolic hypertension in the absence of medications. Funding ReCor Medical.

Published
2018

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