GAstric Bypass to Treat obEse Patients With steAdy hYpertension (GATEWAY)

• ClinicalTrials.gov Identifier: NCT01784848
• Recruitment Status: Completed
• First Posted: February 6, 2013
• Results First Posted: November 6, 2019
• Last Update Posted: April 7, 2022
• Sponsor: Hospital do Coracao
• Collaborator: Ethicon Endo-Surgery
• Information provided by (Responsible Party): Hospital do Coracao

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Systemic Hypertension; Obesity	Procedure: Laparoscopic Roux-en-Y gastric bypass (LRYGB); Other: Clinical treatment	Not Applicable

Detailed Description:

Randomization:

The randomization list is electronically generated through specific software. A block randomization is conducted with varying block sizes at the rate of 1:1. Confidentiality of the randomization list is ensured by the central automated randomization system, through the Internet, available 24 hours a day (ACT Clinic - Sistema de Estudos Clínicos do IEP HCor).

Blinding Scheme:

Because the study involves a surgical procedure, investigators and patients cannot be blind for treatment allocated to patients.

Roux-en-Y Gastroplasty Patients allocated to surgical treatment will be admitted to the hospital to be subjected to a Roux-en-Y gastric bypass with a biliopancreatic loop of 100cm and a alimentary limb of 150cm.

Antihypertensive Treatment:

The treatment of hypertension will be standardized for all study patients. Prescribed drugs will include preferably a renin-angiotensin blocking system drug and a calcium channels blocker, except if these are contraindicated or the patient has achieved good blood pressure control using other drugs prior to study recruitment. Other drugs can be added at discretion of the attending investigator to achieve a target blood pressure of 130 x 80 mmHg. Patients are treated individually for the other associated comorbidities. Obesity treatment in the control group includes dietary advice, motivation for the practice of physical activities, and drug treatments for diabetes and dyslipidemias if applicable.

Laboratory tests and other exams:

All patients will be subjected to the following measurements throughout the study:

• Outpatient Blood Pressure Monitoring (ABPM)
• Blood pressure measurements taken in doctors' offices:
• Central pressure and associated measurements (SphygmoCor®)
• Polysomnography
• Anthropometry
• Nutritional survey
• Laboratory tests
• Echocardiogram
• Electrocardiogram
• Abdominal ultrasound
• Upper gastrointestinal endoscopy with H.pylori testing

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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.
• Actual Study Start Date: May 2013
• Actual Primary Completion Date: May 2017
• Actual Study Completion Date: February 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Laparoscopic Roux-en-Y gastric bypass; Laparoscopic Roux-en-Y gastric bypass performed as a treatment for obesity.	Procedure: Laparoscopic Roux-en-Y gastric bypass (LRYGB); Laparoscopic Roux-en-Y gastric bypass (LRYGB)is the one of the techniques of bariatric surgery; Other: Clinical treatment; 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.
Active Comparator: Clinical treatment; Optimized clinical treatment including medical management of hypertension.	Other: Clinical treatment; 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.

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With a Reduction in the Number of Anti-hypertensive Drugs Used and Maintaining Blood Pressure Below 140x90mmHg [ Time Frame: 12 months ]
   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.

Secondary Outcome Measures :

1. Efficacy of Roux-en-Y Gastroplasty to Decrease the Number of Antihypertensive Drugs. [ Time Frame: 12, 24, 36, 48 and 60 months ]
   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).
2. Absolute Change From Baseline in Blood Pressure Levels [ Time Frame: 12, 24, 36, 48 and 60 months ]
   Change on systemic blood pressure assessed by ambulatory blood pressure monitoring (ABPM).
3. Effect on Central Blood Pressure Augmentation Index and Pulse Wave Velocity [ Time Frame: 12, 24, 36, 48 and 60 months ]
   Change on central blood pressure augmentation index and pulse wave velocity as measured by SphygmoCor device
4. Absolute Change From Baseline on Systolic Blood Pressure [ Time Frame: 12, 24, 36, 48 and 60 months ]
   Absolute change from baseline in systolic blood pressure
5. Absolute Change From Baseline on Diastolic Blood Pressure [ Time Frame: 12, 24, 36, 48 and 60 months ]
   Absolute change from baseline in diastolic blood pressure
6. Absolute Change From Baseline on Weight Loss [ Time Frame: 12, 24, 36, 48 and 60 months ]
   Absolute change from baseline on weight loss
7. Absolute Change From Baseline on BMI [ Time Frame: 12, 24, 36, 48 and 60 months ]
   Absolute change from baseline on BMI
8. Absolute Change From Baseline on Waist Circumference [ Time Frame: 12, 24, 36, 48 and 60 months ]
   Absolute change from baseline on waist circumference
9. Absolute Change From Baseline on Fasting Plasm Glucose Level, HbA1c and Insulin Resistance [ Time Frame: 12, 24, 36, 48 and 60 months ]
   Change from baseline on fasting plasm glucose level, HbA1c and insulin resistance
10. Absolute Change From Baseline on LDL-cholesterol Level [ Time Frame: 12, 24, 36, 48 and 60 months ]
    Absolute change from baseline on LDL-cholesterol level
11. Absolute Change From Baseline on HDL-cholesterol Level [ Time Frame: 12, 24, 36, 48 and 60 months ]
    Absolute change from baseline on HDL-cholesterol level
12. Absolute Change From Baseline on Triglycerides Levels [ Time Frame: 12, 24, 36, 48 and 60 months ]
    Absolute change from baseline on triglycerides levels
13. Absolute Change From Baseline on Uric Acid Levels [ Time Frame: 12, 24, 36, 48 and 60 months ]
    Absolute change from baseline on uric acid levels
14. Absolute Change From Baseline on Ultra-sensitive CRP Levels [ Time Frame: 12, 24, 36, 48 and 60 months ]
    Absolute change from baseline on ultra-sensitive CRP levels
15. Absolute Change From Baseline of Cardiovascular Risk [ Time Frame: 12, 24, 36, 48 and 60 months ]
    Absolute change from baseline of cardiovascular risk calculated by Framingham Score
16. Change on Heart Anatomy [ Time Frame: 12, 24, 36, 48 and 60 months ]
    Change on heart anatomy as evaluated by echocardiogram
17. Change on Sleep Quality [ Time Frame: 12, 24, 36, 48 and 60 months ]
    Change on sleep quality as evaluated by polysomnography
18. Adverse Events [ Time Frame: At any time during the study period ]
    Describe the main adverse events

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Adults aged between 18 and 65 years old.
• hypertension diagnosis defined as in use of at least 2 high blood pressure medication at full doses.
• body mass index between 30,0 and 39,9 kg/m2.

Exclusion Criteria:

• hypertension ≥ 180/120 mmHg;
• cerebrovascular diseases in the last 6 months.
• Cardiovascular diseases (myocardial infarction, angina, cardiac failure) in the last 6 months.
• Baseline psychiatric disorders: schizophrenia, bipolar disorder, severe depression, psychosis.
• Renal diseases: diabetic nephropathy, creatinine clearance < 30 ml/min.
• Patients with secondary hypertension except due to the sleep apnea.
• Advanced peripheral arterial disease
• atrophic gastritis
• Diabetes mellitus type 1 and type 2 with HbA1 c >7,0%
• alcoholism or use of illicit drugs
• smokers
• previous laparotomy
• severe hepatic disorders
• Pregnancy or women not using effective contraceptive methods.
• Recent neoplasm (< 5 years)
• Immunosuppressant drugs
• Unable to understanding and follow the study protocol orientations.

Contacts and Locations

Locations

Brazil

Instituto Dante Pazzanese de Cardiologia

São Paulo, SP, Brazil, 04004-060

Instituto do Coração - Hospital das Clínicas de São Paulo

São Paulo, SP, Brazil, 04004-060

Hospital do Coração - Research Institute

Sao Paulo, Brazil, 04005-000

Sponsors and Collaborators

Hospital do Coracao

Ethicon Endo-Surgery

Investigators

• Principal Investigator: Carlos A Schiavon, MD, PhD; Hospital do Coração

  Study Documents (Full-Text)

Documents provided by Hospital do Coracao:

Study Protocol  [PDF] December 1, 2014

Statistical Analysis Plan  [PDF] December 15, 2016

More Information

Publications of Results:

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. Erratum In: Circulation. 2019 Oct;140(14):e718.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Hospital do Coracao
• ClinicalTrials.gov Identifier: NCT01784848
• Other Study ID Numbers: IEP2013_HAS
• First Posted: February 6, 2013
• Results First Posted: November 6, 2019
• Last Update Posted: April 7, 2022
• Last Verified: March 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Keywords provided by Hospital do Coracao:

high blood pressure; hypertension; bariatric surgery; Laparoscopic Roux-en-Y gastric bypass (LRYGB); obesity

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases