GATEWAY
Phase 3 Randomized Controlled Trial Evaluating the Effect of Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) on Hypertension Medication Reduction, Blood Pressure Levels and Others Cardiovascular Risk Factors.
Sponsor study identifier
interventional
100
1 country
3
Study Start
May 2013
Actual (reported)Primary Completion
May 2017
Actual (reported)Study Completion
February 2022
Actual (reported)Phase 3, unicentric, randomized clinical trial, with allocation concealment and intention-to-treat analysis to evaluate the efficacy of videolaparoscopic Roux-en-Y Gastroplasty to decrease the prescription of antihypertensive drugs maintaining normal levels of blood pressure, decrease systemic arterial blood pressure and other risk factors for cardiovascular events compared to clinical treatments of patients with arterial hypertension.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 4, 2013
Actual (reported)February 6, 2013
Actual (reported)May 2013
Actual (reported)May 2017
Actual (reported)November 6, 2019
Actual (reported)February 2022
Actual (reported)Number of Participants With a Reduction in the Number of Anti-hypertensive Drugs Used and Maintaining Blood Pressure Below 140x90mmHg
Evaluate the efficacy of Roux-en-Y Gastric Bypass on the reduction of the number of antihypertensive drugs, maintaining a controlled blood pressure (\<140x90 mmHg), in 12 months.
12 months
Efficacy of Roux-en-Y Gastroplasty to Decrease the Number of Antihypertensive Drugs.
12, 24, 36, 48 and 60 months
Absolute Change From Baseline in Blood Pressure Levels
12, 24, 36, 48 and 60 months
Effect on Central Blood Pressure Augmentation Index and Pulse Wave Velocity
12, 24, 36, 48 and 60 months
Absolute Change From Baseline on Systolic Blood Pressure
12, 24, 36, 48 and 60 months
Absolute Change From Baseline on Diastolic Blood Pressure
12, 24, 36, 48 and 60 months
Laparoscopic Roux-en-Y gastric bypass performed as a treatment for obesity.
Optimized clinical treatment including medical management of hypertension.
Laparoscopic Roux-en-Y gastric bypass (LRYGB)is the one of the techniques of bariatric surgery
Medical treatment aiming the control of risk factors for cardiovascular diseases (including adequate control of blood pressure), psychological assistance and dietetic advice for body weight reduction.
Instituto Dante Pazzanese de Cardiologia
São Paulo, São Paulo, 04004-060, Brazil
Instituto do Coração - Hospital das Clínicas de São Paulo
São Paulo, São Paulo, 04004-060, Brazil
Hospital do Coração - Research Institute
São Paulo, 04005-000, Brazil
Schiavon CA, Bersch-Ferreira AC, Santucci EV, Oliveira JD, Torreglosa CR, Bueno PT, Frayha JC, Santos RN, Damiani LP, Noujaim PM, Halpern H, Monteiro FLJ, Cohen RV, Uchoa CH, de Souza MG, Amodeo C, Bortolotto L, Ikeoka D, Drager LF, Cavalcanti AB, Berwanger O. Effects of Bariatric Surgery in Obese Patients With Hypertension: The GATEWAY Randomized Trial (Gastric Bypass to Treat Obese Patients With Steady Hypertension). Circulation. 2018 Mar 13;137(11):1132-1142. doi: 10.1161/CIRCULATIONAHA.117.032130. Epub 2017 Nov 13.
Schiavon CA, Ikeoka D, Santucci EV, Santos RN, Damiani LP, Bueno PT, Oliveira JD, Torreglosa CR, Bersch-Ferreira AC, Miranda TA, Barros S, Halpern H, Monteiro FLJ, Cohen RV, Noujaim PM, de Souza MG, Amodeo C, Bortolotto LA, Berwanger O, Cavalcanti AB, Drager LF. Effects of Bariatric Surgery Versus Medical Therapy on the 24-Hour Ambulatory Blood Pressure and the Prevalence of Resistant Hypertension. Hypertension. 2019 Mar;73(3):571-577. doi: 10.1161/HYPERTENSIONAHA.118.12290.
Carlos A Schiavon, MD, PhD
Hospital do Coração
100 participants (actual enrollment reported by the registry).
First Submitted
February 4, 2013
First Posted
February 6, 2013
Study Start
May 2013
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Schiavon CA, Santos RN, Santucci EV, Noujaim PM, Cavalcanti AB, Drager LF. Does the RYGB common limb length influence hypertension remission and cardiometabolic risk factors? Data from the GATEWAY trial. Surg Obes Relat Dis. 2019 Feb;15(2):211-217. doi: 10.1016/j.soard.2018.11.022. Epub 2018 Nov 27.
Schiavon CA, Cavalcanti AB, Oliveira JD, Machado RHV, Santucci EV, Santos RN, Oliveira JS, Damiani LP, Junqueira D, Halpern H, Monteiro FLJ, Noujaim PM, Cohen RV, de Sousa MG, Bortolotto LA, Berwanger O, Drager LF. Randomized Trial of Effect of Bariatric Surgery on Blood Pressure After 5 Years. J Am Coll Cardiol. 2024 Feb 13;83(6):637-648. doi: 10.1016/j.jacc.2023.11.032.
Schiavon CA, Bhatt DL, Ikeoka D, Santucci EV, Santos RN, Damiani LP, Oliveira JD, Machado RHV, Halpern H, Monteiro FLJ, Noujaim PM, Cohen RV, de Souza MG, Amodeo C, Bortolotto LA, Berwanger O, Cavalcanti AB, Drager LF. Three-Year Outcomes of Bariatric Surgery in Patients With Obesity and Hypertension : A Randomized Clinical Trial. Ann Intern Med. 2020 Nov 3;173(9):685-693. doi: 10.7326/M19-3781. Epub 2020 Aug 18.
Schiavon CA, Ikeoka DT, de Sousa MG, Silva CR, Bersch-Ferreira AC, de Oliveira JD, Noujaim PM, Cohen RV, Amodeo C, Berwanger O; GATEWAY (GAstric bypass surgery to TrEat patients With steAdy hYpertension) Investigators. Effects of gastric bypass surgery in patients with hypertension: rationale and design for a randomised controlled trial (GATEWAY study). BMJ Open. 2014 Sep 8;4(9):e005702. doi: 10.1136/bmjopen-2014-005702.
Primary Completion
May 2017
Actual (reported)Study Completion
February 2022
Actual (reported)Last Updated
April 7, 2022
Results First Posted
November 6, 2019
Record last verified: 2022-03
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Source: ClinicalTrials.gov.
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