36-month durability of ultrasound renal denervation for hypertension resistant to combination therapy in RADIANCE-HTN TRIO

On behalf of the RADIANCE-HTN Investigators

doi:10.1038/s41440-024-01854-w

36-month durability of ultrasound renal denervation for hypertension resistant to combination therapy in RADIANCE-HTN TRIO

On behalf of the RADIANCE-HTN Investigators

Research output: Contribution to journal › Article › peer-review

1 Scopus citations

Abstract

Endovascular ultrasound renal denervation (uRDN) reduced blood pressure (BP) compared to sham at 2 months in patients with resistant hypertension in the multicenter, blinded, randomized, sham-controlled RADIANCE-HTN TRIO trial. This analysis evaluates longer-term outcomes of patients randomized to uRDN. Patients with resistant hypertension to a 3-drug combination pill were randomized to uRDN (n = 69) or sham (n = 67). From 2-5 months, patients followed a standardized anti-hypertensive medication (AHM) titration protocol. At 6 months, patients were unblinded and received AHM per standard of care. In the uRDN group, 71% (49/69) completed 36-month follow-up. Screening office BP was 159/103 on 3.9 AHM. Baseline office BP on the single-pill combination was 153/99 mmHg. At 36 months, office BP changed by −14.5 ± 26.1/−9.0 ± 14.8 mmHg from screening (p < 0.001 for both) and −8.0 ± 24.5/−5.0 ± 14.6 mmHg from baseline (p = 0.007; p = 0.022) on 3.7 AHM. The efficacy of uRDN was durable to 36 months in patients with resistant hypertension with no safety concerns. (Figure presented.)

Original language	English (US)
Pages (from-to)	3467-3472
Number of pages	6
Journal	Hypertension Research
Volume	47
Issue number	12
DOIs	https://doi.org/10.1038/s41440-024-01854-w
State	Published - Dec 2024

Funding

Yale Wang15, Nedaa Skeik15, Richard Bae15, Amy McMeans15, JoAnne Goldman15, Rose Peterson15, James Stephen Jenkins16, Isabelle Tutor16, Michael Harrison16, Angel Penning16, Chandan Devireddy17, Janice Lea17, Amanda Fiebach17, Claudia Merlin17, Florian Rader18, Suhail Dohad18, Anne Tran18, Kirin Bhatia18, Naomi D L Fisher19, Piotr Sobieszczyk19, Ian Halliday19, Tay Munson19, Jason Lindsey20, Steven Laster20, Mathew Bunte20, Anthony Hart20, Dana King20, Jamie Hall20, Kintur Sanghvi21, Courtney Krathen21, Luot Lewis21, Ashley Willitts21, Thomas Todoran22, Jan Basile22, Anthony Awkar22, Casey Palmer22, Anna Tecklenburg22, John Schindler23, John Pacella23, Matthew Muldoon23, MaryJo Albright23, Tracy Nicholson23, John Flack24, Youseff Chami24, Abdul Moiz Hafiz24, Emily Starkey24, Kristal Adams24, Nelson Bernardo25, Judith Veis25, Hayder Hashim25, Suman Singh25, Donna Whitman25, Rick Stouffer26, Alan Hinderliter26, Meghan Allen26, Tatum Scholl26, Pete Fong27, James Gainer27, Sherron Crook27, Ellen Hatchcock27, Debbie Cohen28, Jay Giri28, Taisei Kobayashi28, Robin Neubauer28, Suveeksha Naidu28, Ajay J. Kirtane29, Jai Radhakrishnan29, Candido Batres29, Suzanne Edwards29, Matheen Khuddus30, Suzanne Zentko30, Abby Touchton30, Marti Roberson30, Michael J. Bloch2, Abhilash Akinapelli2, Lisa English2, Bridget Neumann2, Farrel Mendelsohn31, Hutton Brantley31, Thomas Cawthon31, Susan DeRamus31, Wesley Wade31, Robert Fishman32, Edward Tuohy32, Jessica LeBlanc32, Tina McCurry32, Amar Krishnaswamy33, Luke Laffin33, Christopher Bajzer33, Marilyn Boros33, Monica Branche33, Josephine Abraham34, Anu Abraham34, Inge Stijleman34, David Hsi35, Scott Martin35, Edward Portnay35, Maryann Fiebach35, Carolina Garavito35, Todd Adams36, Andrew Teklinski36, Adam Leech36, Patrick Drilling36, Lynda Tulik36, Keith Benzuly37, James Paparello37, Dan Fintel37, Haydee Ramirez37, Lauren Kats37, Paul Huang38, Santanu Biswas38, Serena Risher38, Kristina Pratt38, Uzoma Ibebuogu39, Karen Johnson39, William Cushman39, Lisa Jones39, Leigh Jackson39, David Landers40, Tilak Pasala40, Thomas Salazer40, Peter Canino40, Patricia Arakelian40, Yi-Ming Yang41, Asma Khaliq41, Mitchell Weinberg41, Yihenew Abetu41, Alana Gulliver41, J. P. Reilly42, Joseph Garasic43, Atul Chugh44, Barry Bertolet45, Brian Go46, Raghava Gallapudi47, Joel Cohn48, Kevin Rogers49, Manish Saxena50, Anthony Mathur50, Ajay Jain50, Armida Balawon50, Oliver Zongo50, Christine Topham50, Andrew Sharp51, Richard Anderson51, Elizabeth Thompson51, Nikki Spiro51, Elizabeth Hodges51, Jaqueline Holder51, Timothy Ellam52, Alan Bagnall52, Ralph Jackson52, Victoria Bridgett52, Peter Wilson52, Neelanjan Das53, Timothy Doulton53, David Loader53, Gemma Hector53, Terry Levy54, Clare Bent54, Vivek Kodoth54, Stephanie Horler54, Sara Nix54, Nicholas Robinson55, Firas Al-Janabi55, Jeremy Sayer55, Sudha Ganesh Iyer55, Emily Redman55, Jonaifah Ramirez55, Sandosh Padmanabhan56, Faisal Sharif57, Aishah Alhmoudi57, Mattia Lunardi57, Eileen Coen57, Nicola Glynn57, Felix Mahfoud58, Lucas Lauder58, Saarraaken Kulenthiran58, Christina Koch58, Angelika Wachter58, Roland Schmieder59, Axel Schmid59, Dennis Kannenkeril59, Ulrike Heinritz59, Kerstin Endres-Frohlich59, Philipp Lurz60, Karl Rommel60, Fengler60, Martin Petzold60, Margit B\u00FCttner60, Joachim Weil61, Tolga Agdirlioglu61, Tanja K\u00F6llner61, Jeannine Stephan61, Nikolaos Dagkonakis62, Frank Hamann62, Ute Ettl62, Ulrike Petzsche62, Peter Reimer63, Martin Hausberg63, Ralf Hinrichs63, Isabella Di Ponio-Voit63, Matthias Lutz64, Philippe Gosse65, Antoine Cremer65, Panteleimon Papadopoulos65, Julie Gaudissard65, Florent Maire65, Michel Azizi66, Marc Sapoval66, Marine Livrozet66, Asma Regrag66, Valerie Paquet66, Pascal Delsart67, Justin Hennicaux67, Coralie Sommeville67, Fabien Bertrand67, Joost Daemen68, Melvin Lafeber68, Victor Zeijen68, Amo Ruiter68, Elisabeth Huijskens68, Jan van Ramshorst69, Panagiotis Xaplanteris70, Rachid Briki70, Quentin de Hemptinne70, Severine Pascal70, Katty Renard70, Pascal Lefebvre71, Bert Ferdinande72, Juan F. Iglesias73, Georg Ehert73, Laetitia Gallego73, Kevin Dobretz73, Sylviane Bottone73, Kintur Sanghvi21, Josh Costello21, Courtney Krathan21, Luot Lewis21, Andrew McElvarr21, John Reilly16, Stephen Jenkins16, Michael Cash16, Shannon Williams16, Maria Jarvis16, Pete Fong27, Cheryl Laffer27, James Gainer27, Mark Robbins27, Sherron Crook27, Sarita Maddel27, David Hsi35, Scott Martin35, Edward Portnay35, Maryanne Ducey35, Suzanne Rose35, Elizabeth DelMastro35, Sripal Bangalore74, Stephen Williams74, Stanley Cabos74, Carolina Rodriguez Alvarez74, Thomas Todoran22, Jan Basile22, Eric Powers22, Emily Hodskins22, Vijay Paladugu22, Anna Tecklenburg22, Chandan Devireddy17, Janice Lea17, Bryan Wells17, Amanda Fiebach17, Claudia Merlin17, Florian Rader18, Suhail Dohad18, Hyun-Min Kim18, Mohammad Rashid18, Josephine Abraham34, Theophilus Owan34, Anu Abraham34, Iran Lavasani34, Hailey Neilson34, David Calhoun75, Thomas McElderry75, William Maddox75, Suzanne Oparil75, Sheila Kinder75, Ajay J. Kirtane29, Jai Radhakrishnan29, Candido Batres29, Suzanne Edwards29, Joseph Garasic76, Doug Drachman76, Randy Zusman76, Kenneth Rosenfield76, Danny Do76, Matheen Khuddus30, Suzanne Zentko30, James O\u2019Meara30, Ilie Barb30, Abby Foster30, Alice Boyette30, Yale Wang15, Desmond Jay15, Nedaa Skeik15, Robert Schwartz15, Rose Peterson15, Jo Anne Goldman15, Jessie Goldman77, Gary Ledley77, Nancy Katof77, Srinivasa Potluri78, Scott Biedermann Jacquelyn Ward78, Megan White78, Naomi DL Fisher19, Laura Mauri19, Piotr Sobieszczky19, Alex Smith19, Laura Aseltine19, Rick Stouffer26, Alan Hinderliter26, Eric Pauley26, Tyrone Wade26, David Zidar79, Mehdi Shishehbor79, Barry Effron79, Marco Costa79, Terence Semenec79, Michael J. Bloch2, Chanwit Roongsritong2, Priscilla Nelson2, Bridget Neumann2, Debbie Cohen80, Jay Giri80, Robin Neubauer80, Thu Vo80, Atul R. Chugh44, Pei-Hsiu Huang81, Powell Jose81, John Flack24, Robert Fishman32, Michael Jones82, Todd Adams36, Christopher Bajzer33, Manish Saxena83, Melvin D. Lobo83, Anthony Mathur83, Ajay Jain83, Armida Balawon83, Olivier Zongo83, Terry Levy84, Clare Bent84, David Beckett84, Nicki Lakeman84, Sarah Kennard84, Andrew Sharp85, Richard J D\u2019Souza85, Sarah Statton85, Lindsay Wilkes85, Christine Anning85, Jeremy Sayer86, Sudha Ganesh Iyer86, Nicholas Robinson86, Annaliza Sevillano86, Madelaine Ocampo86, Robert Gerber87, Mohamad Faris87, Andrew John Marshall87, Janet Sinclair87, Hayley Pepper87, Justin Davies88, Neil Chapman88, Paula Burak88, Paula Carvelli88, Sachin Jadhav89, Jane Quinn89, Lars Christian Rump90, Johannes Stegbauer90, Lars Schimm\u00F6ller90, Sebastian Potthoff90, Claudia Schmid90, Sylvia Roeder90, Joachim Weil61, Lukas Hafer61, Tolga Agdirlioglu61, Tanja K\u00F6llner61, Felix Mahfoud91, Michael B\u00F6hm91, Sebastian Ewen91, Saarraaken Kulenthiran91, Angelika Wachter91, Christina Koch91, Philipp Lurz60, Karl Fengler60, Karl-Philipp Rommel60, Kai Trautmann60, Martin Petzold60, Roland E. Schmieder92, Christian Ott92, Axel Schmid92, Michael Uder92, Ulrike Heinritz92, Kerstin Fr\u00F6hlich-Endres92, Sabine Genth-Zotz93, Denise K\u00E4mpfner93, Armin Grawe93, Johannes H\u00F6hne93, B\u00E4rbel Kaesberger93, Constantin von zur M\u00FChlen94, Dennis Wolf94, Markus Welzel94, Gudrun Heinrichs94, Barbara Trabitzsch94, Philippe Gosse65, Antoine Cremer65, Herv\u00E9 Trillaud65, Panteleimon Papadopoulos65, Florent Maire65, Julie Gaudissard65, Michel Azizi66, Marc Sapoval66, Erika Cornu66, David Fouassier66, Marine Livrozet66, Aur\u00E9lien Lorthioir66, Val\u00E9rie Paquet66, Atul Pathak95, Benjamin Honton95, Marianne Cottin95, Fr\u00E9d\u00E9ric Petit95, Pierre Lantelme96, Constance Berge96, Pierre-Yves Courand96, Fatou Langevin96, Pascal Delsart67, Benjamin Longere67, Guillaume Ledieu67, Fran\u00E7ois Pontana67, Coralie Sommeville67, Fabien Bertrand67, Joost Daemen68, Lida Feyz68, Victor Zeijen68, Arno Ruiter68, Elisabeth Huyskens68, Peter Blankestijn97, Michiel Voskuil97, Zwaantina Rittersma97, Helma Dolmans97, A. A. Kroon98, W. H. van Zwam98, Jeannique Vranken98, Claudia de Haan98, Alexandre Persu99, Jean Renkin99, Fr\u00E9d\u00E9ric Maes99, Christophe Beauloye99, Jean-Philippe Lengel\u00E999, Dominique Huyberechts99, Anne Bouvier99, Adam Witkowski100, Andrzej Januszewicz100, Jacek K\u0105dziela100, Aleksander Prejbisj100, Dagmara Hering101, Dariusz Ciecwierz101, Milosz J. Jaguszewski101, Radoslaw Owczuk101, Dariusz Ciecwierz101, Milosz J. Jaguszewski101, Yale Wang15, Desmond Jay15, Nedaa Skeik15, Robert Schwartz15, Florian Rader18, Suhail Dohad18, Ronald Victor18, Kintur Sanghvi21, Josh Costello21, Courtney Walsh21, Josephine Abraham34, Theophilus Owan34, Anu Abraham34, Naomi D L Fisher19, Laura Mauri19, Piotr Sobieszczky19, Jonathan Williams19, Michael J. Bloch2, Chanwit Roongsritong2, Thomas Todoran22, Jan Basile22, Eric Powers22, Emily Hodskins22, Pete Fong27, Cheryl Laffer27, James Gainer27, Mark Robbins27, John Reilly16, Michael Cash16, Jessie Goldman77, Sandeep Aggarwal77, Gary Ledley77, David Hsi35, Scott Martin35, Edward Portnay35, David Calhoun75, Thomas McElderry75, William Maddox75, Suzanne Oparil75, Pei-Hsiu Huang81, Powell Jose81, Matheen Khuddus30, Suzanne Zentko30, James O\u2019Meara30, Ilie Barb30, Joseph Garasic76, Doug Drachman76, Randy Zusman76, Kenneth Rosenfield76, Chandan Devireddy17, Janice Lea17, Bryan Wells17, Rick Stouffer26, Alan Hinderliter26, Eric Pauley26, Srinivasa Potluri78, Scott Biedermann78, Sripal Bangalore74, Stephen Williams74, David Zidar79, Mehdi Shishehbor79, Barry Effron79, Marco Costa79, Ajay J. Kirtane29, Jai Radhakrishnan29, Melvin D. Lobo83, Manish Saxena83, Anthony Mathur83, Ajay Jain83, Jeremy Sayer102, Sudha Ganesh Iyer102, Nicholas Robinson102, Sadat Ali Edroos102, Terry Levy54, Amit Patel54, David Beckett54, Clare Bent54, Justin Davies103, Neil Chapman103, Matthew Shun Shin103, James Howard103, Andrew S P Sharp85, Anil Joseph85, Richard D\u2019Souza85, Robert Gerber104, Mohamad Faris104, Andrew John Marshall104, Cristina Elorz104, Philipp Lurz105, Robert H\u00F6llriegel105, Karl Fengler105, Karl-Philipp Rommel105, Felix Mahfoud58, Michael B\u00F6hm58, Sebastian Ewen58, Jelena Lucic58, Roland E. Schmieder59, Christian Ott59, Axel Schmid59, Michael Uder59, Christian Rump106, Johannes Stegbauer106, Patric Kr\u00F6pil106, Michel Azizi66, Marc Sapoval66, Erika Cornu66, David Fouassier66, Philippe Gosse65, Antoine Cremer65, Herv\u00E9 Trillaud65, Panteleimon Papadopoulos65, Atul Pathak95, Benjamin Honton95, Pierre Lantelme96, Constance Berge96, Pierre-Yves Courand96, Joost Daemen68, Lida Feyz68, Peter Blankestijn97, Michiel Voskuil97, Zwaantina Rittersma97, A. A. Kroon98, W. H. van Zwam98, Alexandre Persu99, Jean Renkin99

Keywords

Hypertension
blood pressure
renal denervation
ultrasound

ASJC Scopus subject areas

Internal Medicine
Physiology
Cardiology and Cardiovascular Medicine

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10.1038/s41440-024-01854-w

Cite this

@article{b20aa59698364231a3a1bec899a0bfe8,

title = "36-month durability of ultrasound renal denervation for hypertension resistant to combination therapy in RADIANCE-HTN TRIO",

abstract = "Endovascular ultrasound renal denervation (uRDN) reduced blood pressure (BP) compared to sham at 2 months in patients with resistant hypertension in the multicenter, blinded, randomized, sham-controlled RADIANCE-HTN TRIO trial. This analysis evaluates longer-term outcomes of patients randomized to uRDN. Patients with resistant hypertension to a 3-drug combination pill were randomized to uRDN (n = 69) or sham (n = 67). From 2-5 months, patients followed a standardized anti-hypertensive medication (AHM) titration protocol. At 6 months, patients were unblinded and received AHM per standard of care. In the uRDN group, 71% (49/69) completed 36-month follow-up. Screening office BP was 159/103 on 3.9 AHM. Baseline office BP on the single-pill combination was 153/99 mmHg. At 36 months, office BP changed by −14.5 ± 26.1/−9.0 ± 14.8 mmHg from screening (p < 0.001 for both) and −8.0 ± 24.5/−5.0 ± 14.6 mmHg from baseline (p = 0.007; p = 0.022) on 3.7 AHM. The efficacy of uRDN was durable to 36 months in patients with resistant hypertension with no safety concerns. (Figure presented.)",

keywords = "Hypertension, blood pressure, renal denervation, ultrasound",

author = "{On behalf of the RADIANCE-HTN Investigators} and Bloch, {Michael J.} and Kirtane, {Ajay J.} and Michel Azizi and Felix Mahfoud and Jan Basile and Joost Daemen and Manish Saxena and Lisa Thackeray and Maureen McGuire and Lisa Claude and Schmieder, {Roland E.} and Patric Kr{\"o}pil and Johannes Stegbauer and Christian Rump and Michael Uder and Christian Ott and Jelena Lucic and Sebastian Ewen and Michael B{\"o}hm and Rommel, {Karl Philipp} and Karl Fengler and Robert H{\"o}llriegel and Philipp Lurz and Cristina Elorz and Marshall, {Andrew John} and Mohamad Faris and Robert Gerber and Richard D{\textquoteright}Souza and Anil Joseph and Sharp, {Andrew S.P.} and James Howard and Shin, {Matthew Shun} and Neil Chapman and Justin Davies and David Beckett and Amit Patel and Edroos, {Sadat Ali} and Nicholas Robinson and Iyer, {Sudha Ganesh} and Jeremy Sayer and Scott Biedermann and Sandeep Aggarwal and Jonathan Williams and Courtney Walsh and Ronald Victor and Radoslaw Owczuk and Jaguszewski, {Milosz J.} and Dan Fintel and James Paparello and Keith Benzuly",

note = "Publisher Copyright: {\textcopyright} The Author(s) 2024.",

year = "2024",

month = dec,

doi = "10.1038/s41440-024-01854-w",

language = "English (US)",

volume = "47",

pages = "3467--3472",

journal = "Hypertension Research",

issn = "0916-9636",

publisher = "Springer Nature",

number = "12",

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T1 - 36-month durability of ultrasound renal denervation for hypertension resistant to combination therapy in RADIANCE-HTN TRIO

AU - On behalf of the RADIANCE-HTN Investigators

AU - Bloch, Michael J.

AU - Kirtane, Ajay J.

AU - Azizi, Michel

AU - Mahfoud, Felix

AU - Basile, Jan

AU - Daemen, Joost

AU - Saxena, Manish

AU - Thackeray, Lisa

AU - McGuire, Maureen

AU - Claude, Lisa

AU - Schmieder, Roland E.

AU - Kröpil, Patric

AU - Stegbauer, Johannes

AU - Rump, Christian

AU - Uder, Michael

AU - Ott, Christian

AU - Lucic, Jelena

AU - Ewen, Sebastian

AU - Böhm, Michael

AU - Rommel, Karl Philipp

AU - Fengler, Karl

AU - Höllriegel, Robert

AU - Lurz, Philipp

AU - Elorz, Cristina

AU - Marshall, Andrew John

AU - Faris, Mohamad

AU - Gerber, Robert

AU - D’Souza, Richard

AU - Joseph, Anil

AU - Sharp, Andrew S.P.

AU - Howard, James

AU - Shin, Matthew Shun

AU - Chapman, Neil

AU - Davies, Justin

AU - Beckett, David

AU - Patel, Amit

AU - Edroos, Sadat Ali

AU - Robinson, Nicholas

AU - Iyer, Sudha Ganesh

AU - Sayer, Jeremy

AU - Biedermann, Scott

AU - Aggarwal, Sandeep

AU - Williams, Jonathan

AU - Walsh, Courtney

AU - Victor, Ronald

AU - Owczuk, Radoslaw

AU - Jaguszewski, Milosz J.

AU - Fintel, Dan

AU - Paparello, James

AU - Benzuly, Keith

PY - 2024/12

Y1 - 2024/12

N2 - Endovascular ultrasound renal denervation (uRDN) reduced blood pressure (BP) compared to sham at 2 months in patients with resistant hypertension in the multicenter, blinded, randomized, sham-controlled RADIANCE-HTN TRIO trial. This analysis evaluates longer-term outcomes of patients randomized to uRDN. Patients with resistant hypertension to a 3-drug combination pill were randomized to uRDN (n = 69) or sham (n = 67). From 2-5 months, patients followed a standardized anti-hypertensive medication (AHM) titration protocol. At 6 months, patients were unblinded and received AHM per standard of care. In the uRDN group, 71% (49/69) completed 36-month follow-up. Screening office BP was 159/103 on 3.9 AHM. Baseline office BP on the single-pill combination was 153/99 mmHg. At 36 months, office BP changed by −14.5 ± 26.1/−9.0 ± 14.8 mmHg from screening (p < 0.001 for both) and −8.0 ± 24.5/−5.0 ± 14.6 mmHg from baseline (p = 0.007; p = 0.022) on 3.7 AHM. The efficacy of uRDN was durable to 36 months in patients with resistant hypertension with no safety concerns. (Figure presented.)

AB - Endovascular ultrasound renal denervation (uRDN) reduced blood pressure (BP) compared to sham at 2 months in patients with resistant hypertension in the multicenter, blinded, randomized, sham-controlled RADIANCE-HTN TRIO trial. This analysis evaluates longer-term outcomes of patients randomized to uRDN. Patients with resistant hypertension to a 3-drug combination pill were randomized to uRDN (n = 69) or sham (n = 67). From 2-5 months, patients followed a standardized anti-hypertensive medication (AHM) titration protocol. At 6 months, patients were unblinded and received AHM per standard of care. In the uRDN group, 71% (49/69) completed 36-month follow-up. Screening office BP was 159/103 on 3.9 AHM. Baseline office BP on the single-pill combination was 153/99 mmHg. At 36 months, office BP changed by −14.5 ± 26.1/−9.0 ± 14.8 mmHg from screening (p < 0.001 for both) and −8.0 ± 24.5/−5.0 ± 14.6 mmHg from baseline (p = 0.007; p = 0.022) on 3.7 AHM. The efficacy of uRDN was durable to 36 months in patients with resistant hypertension with no safety concerns. (Figure presented.)

KW - Hypertension

KW - blood pressure

KW - renal denervation

KW - ultrasound

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DO - 10.1038/s41440-024-01854-w

M3 - Article

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SN - 0916-9636

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JO - Hypertension Research

JF - Hypertension Research

IS - 12

ER -

36-month durability of ultrasound renal denervation for hypertension resistant to combination therapy in RADIANCE-HTN TRIO

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