Systemic HypertensionGATEWAYNCT01784848
GAstric Bypass to Treat obEse Patients With steAdy hYpertension
A study testing Laparoscopic Roux-en-Y gastric bypass (LRYGB) and Clinical treatment in people with Systemic Hypertension and Obesity, run by Hospital do Coracao at 3 sites in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Hypertension, Obesity
- What is being tested?
- Laparoscopic Roux-en-Y gastric bypass (LRYGB) and Clinical treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesBrazil
- Study dates
- May 2013to Feb 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
Brazil3 sites
Instituto Dante Pazzanese de Cardiologia
São Paulo, São Paulo, 04004-060
Instituto do Coração - Hospital das Clínicas de São Paulo
São Paulo, São Paulo, 04004-060
Hospital do Coração - Research Institute
São Paulo, 04005-000
About this study
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.
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.
Read the 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
- Conditions
- Systemic Hypertension, Obesity
- Being tested
- Laparoscopic Roux-en-Y gastric bypass (LRYGB), Clinical treatment
- Keywords
- high blood pressure, hypertension, bariatric surgery, Laparoscopic Roux-en-Y gastric bypass (LRYGB), obesity
- Medical subject headings
- Hypertension, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Roux-en-Y gastric bypass (LRYGB)Procedure or surgery
Laparoscopic Roux-en-Y gastric bypass (LRYGB)is the one of the techniques of bariatric surgery
Clinical treatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Roux-en-Y gastric bypass | Experimental | Laparoscopic Roux-en-Y gastric bypass performed as a treatment for obesity. Receives: Procedure: Laparoscopic Roux-en-Y gastric bypass (LRYGB); Other: Clinical treatment |
| Clinical treatment | Active comparator | Optimized clinical treatment including medical management of hypertension. Receives: Other: Clinical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (18)
Efficacy of Roux-en-Y Gastroplasty to Decrease the Number of Antihypertensive Drugs.
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).
Measured: 12, 24, 36, 48 and 60 months
Absolute Change From Baseline in Blood Pressure Levels
Change on systemic blood pressure assessed by ambulatory blood pressure monitoring (ABPM).
Measured: 12, 24, 36, 48 and 60 months
Effect on Central Blood Pressure Augmentation Index and Pulse Wave Velocity
Change on central blood pressure augmentation index and pulse wave velocity as measured by SphygmoCor device
Measured: 12, 24, 36, 48 and 60 months
Absolute Change From Baseline on Systolic Blood Pressure
Absolute change from baseline in systolic blood pressure
Measured: 12, 24, 36, 48 and 60 months
Absolute Change From Baseline on Diastolic Blood Pressure
Absolute change from baseline in diastolic blood pressure
Measured: 12, 24, 36, 48 and 60 months
Absolute Change From Baseline on Weight Loss
Absolute change from baseline on weight loss
Measured: 12, 24, 36, 48 and 60 months
Absolute Change From Baseline on BMI
Absolute change from baseline on BMI
Measured: 12, 24, 36, 48 and 60 months
Absolute Change From Baseline on Waist Circumference
Absolute change from baseline on waist circumference
Measured: 12, 24, 36, 48 and 60 months
Absolute Change From Baseline on Fasting Plasm Glucose Level, HbA1c and Insulin Resistance
Change from baseline on fasting plasm glucose level, HbA1c and insulin resistance
Measured: 12, 24, 36, 48 and 60 months
Absolute Change From Baseline on LDL-cholesterol Level
Absolute change from baseline on LDL-cholesterol level
Measured: 12, 24, 36, 48 and 60 months
Absolute Change From Baseline on HDL-cholesterol Level
Absolute change from baseline on HDL-cholesterol level
Measured: 12, 24, 36, 48 and 60 months
Absolute Change From Baseline on Triglycerides Levels
Absolute change from baseline on triglycerides levels
Measured: 12, 24, 36, 48 and 60 months
Absolute Change From Baseline on Uric Acid Levels
Absolute change from baseline on uric acid levels
Measured: 12, 24, 36, 48 and 60 months
Absolute Change From Baseline on Ultra-sensitive CRP Levels
Absolute change from baseline on ultra-sensitive CRP levels
Measured: 12, 24, 36, 48 and 60 months
Absolute Change From Baseline of Cardiovascular Risk
Absolute change from baseline of cardiovascular risk calculated by Framingham Score
Measured: 12, 24, 36, 48 and 60 months
Change on Heart Anatomy
Change on heart anatomy as evaluated by echocardiogram
Measured: 12, 24, 36, 48 and 60 months
Change on Sleep Quality
Change on sleep quality as evaluated by polysomnography
Measured: 12, 24, 36, 48 and 60 months
Adverse Events
Describe the main adverse events
Measured: At any time during the study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2017
- Study completionFeb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Systemic HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital do Coracao
- Sponsor type
- University, hospital or other
- Collaborators
- Ethicon Endo-Surgery
- Responsible party
- Sponsor
- Investigators
- Carlos A Schiavon, MD, PhD, Principal investigator, Hospital do Coração
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01784848
- Sponsor's protocol ID
- IEP2013_HAS
- Acronym
- GATEWAY
- Status last verified
- Mar 2022
- First submitted
- 4 Feb 2013
- Last updated
- 7 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29133606Schiavon 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.
PubMed 30661477Schiavon 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.
PubMed 30679036Schiavon 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.
PubMed 38325988Schiavon 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.
PubMed 32805133Schiavon 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.
PubMed 25200559
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01784848
- Acronym / sponsor ID
- GATEWAY / IEP2013_HAS
- Conditions
- Systemic Hypertension, Obesity
- Keywords
- high blood pressure, hypertension, bariatric surgery, Laparoscopic Roux-en-Y gastric bypass (LRYGB), obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hospital do CoracaoUniversity, hospital or other
- Collaborators
- Ethicon Endo-Surgery
- Study start
- May 2013 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Feb 2022 (actual)
- First posted
- 6 Feb 2013 (estimated)
- Results
- Posted 6 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Roux-en-Y gastric bypass | Experimental | Procedure: Laparoscopic Roux-en-Y gastric bypass (LRYGB), Other: Clinical treatmentLaparoscopic Roux-en-Y gastric bypass performed as a treatment for obesity. |
| Clinical treatment | Active comparator | Other: Clinical treatmentOptimized clinical treatment including medical management of hypertension. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic Roux-en-Y gastric bypass (LRYGB)Laparoscopic Roux-en-Y gastric bypass (LRYGB)is the one of the techniques of bariatric surgery | Procedure or surgery | Laparoscopic Roux-en-Y gastric bypass |
| Clinical treatmentMedical 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. | Other | Clinical treatment, Laparoscopic Roux-en-Y gastric bypass |
Primary outcome
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.
18 secondary outcomes
Efficacy of Roux-en-Y Gastroplasty to Decrease the Number of Antihypertensive Drugs.
Time frame: 12, 24, 36, 48 and 60 months
Absolute Change From Baseline in Blood Pressure Levels
Time frame: 12, 24, 36, 48 and 60 months
Effect on Central Blood Pressure Augmentation Index and Pulse Wave Velocity
Time frame: 12, 24, 36, 48 and 60 months
Absolute Change From Baseline on Systolic Blood Pressure
Time frame: 12, 24, 36, 48 and 60 months
Absolute Change From Baseline on Diastolic Blood Pressure
Time frame: 12, 24, 36, 48 and 60 months
Absolute Change From Baseline on Weight Loss
Time frame: 12, 24, 36, 48 and 60 months
Absolute Change From Baseline on BMI
Time frame: 12, 24, 36, 48 and 60 months
Absolute Change From Baseline on Waist Circumference
Time frame: 12, 24, 36, 48 and 60 months
Absolute Change From Baseline on Fasting Plasm Glucose Level, HbA1c and Insulin Resistance
Time frame: 12, 24, 36, 48 and 60 months
Absolute Change From Baseline on LDL-cholesterol Level
Time frame: 12, 24, 36, 48 and 60 months
Absolute Change From Baseline on HDL-cholesterol Level
Time frame: 12, 24, 36, 48 and 60 months
Absolute Change From Baseline on Triglycerides Levels
Time frame: 12, 24, 36, 48 and 60 months
Absolute Change From Baseline on Uric Acid Levels
Time frame: 12, 24, 36, 48 and 60 months
Absolute Change From Baseline on Ultra-sensitive CRP Levels
Time frame: 12, 24, 36, 48 and 60 months
Absolute Change From Baseline of Cardiovascular Risk
Time frame: 12, 24, 36, 48 and 60 months
Change on Heart Anatomy
Time frame: 12, 24, 36, 48 and 60 months
Change on Sleep Quality
Time frame: 12, 24, 36, 48 and 60 months
Adverse Events
Time frame: At any time during the study period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29133606Schiavon 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.
- Results publication: PubMed 30661477Schiavon 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.
- Results publication: PubMed 30679036Schiavon 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.
- Derived from this study: PubMed 38325988Schiavon 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.
- Derived from this study: PubMed 32805133Schiavon 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.
- Derived from this study: PubMed 25200559Schiavon 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos A Schiavon, MD, PhD principal investigator
Hospital do Coração
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Roux-en-Y gastric bypass (LRYGB) and Clinical treatment in people with Systemic Hypertension and Obesity, run by Hospital do Coracao at 3 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With a Reduction in the Number of Anti-hypertensive Drugs Used and Maintaining Blood Pressure Below 140x90mmHg (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01784848, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.