GAstric Bypass to Treat obEse Patients With steAdy hYpertension

NCT01784848 | Completed Results

• 1 other identifier: IEP2013_HAS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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.

Conditions

Systemic Hypertension; Obesity

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (18)

• 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

Study Arms (2)

Laparoscopic Roux-en-Y gastric bypass

EXPERIMENTAL

Laparoscopic Roux-en-Y gastric bypass performed as a treatment for obesity.

Procedure: Laparoscopic Roux-en-Y gastric bypass (LRYGB); Other: Clinical treatment

Clinical treatment

ACTIVE COMPARATOR

Optimized clinical treatment including medical management of hypertension.

Other: Clinical treatment

Interventions

Laparoscopic Roux-en-Y gastric bypass (LRYGB) PROCEDURE

Laparoscopic Roux-en-Y gastric bypass (LRYGB)is the one of the techniques of bariatric surgery

Laparoscopic Roux-en-Y gastric bypass

Clinical treatment OTHER

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.

Clinical treatment; Laparoscopic Roux-en-Y gastric bypass

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hospital do Coracao: lead
• Ethicon Endo-Surgery: collaborator

Study Sites (3)

Instituto Dante Pazzanese de Cardiologia

São Paulo, São Paulo, 04004-060, Brazil

Location

Instituto do Coração - Hospital das Clínicas de São Paulo

São Paulo, São Paulo, 04004-060, Brazil

Location

Hospital do Coração - Research Institute

São Paulo, 04005-000, Brazil

Location

Related Publications (6)

• 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.

  PMID: 29133606 RESULT

• 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.

  PMID: 30661477 RESULT

• 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.

  PMID: 30679036 RESULT

• 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.

  PMID: 38325988 DERIVED

• 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.

  PMID: 32805133 DERIVED

• 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.

  PMID: 25200559 DERIVED

MeSH Terms

Conditions

Hypertension; Obesity

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr Carlos Schiavon
• Organization: HCor

schiavon.ca@gmail.com

1130536611

Study Officials

• Carlos A Schiavon, MD, PhD

  Hospital do Coração

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2013
• First Posted: February 6, 2013
• Study Start: May 1, 2013
• Primary Completion: May 1, 2017
• Study Completion: February 1, 2022
• Last Updated: April 7, 2022
• Results First Posted: November 6, 2019

Record last verified: 2022-03

Locations

BR (3)