Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ethicon Endo-Surgery | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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 ClÃnicos 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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic Roux-en-Y gastric bypass | Experimental | Laparoscopic Roux-en-Y gastric bypass performed as a treatment for obesity. |
|
| Clinical treatment | Active Comparator | Optimized clinical treatment including medical management of hypertension. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic Roux-en-Y gastric bypass (LRYGB) | Procedure | Laparoscopic Roux-en-Y gastric bypass (LRYGB)is the one of the techniques of bariatric surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 12, 24, 36, 48 and 60 months |
| Absolute Change From Baseline in Blood Pressure Levels |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Carlos A Schiavon, MD, PhD | Hospital do Coração | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Dante Pazzanese de Cardiologia | São Paulo | São Paulo | 04004-060 | Brazil | ||
| Instituto do Coração - Hospital das ClÃnicas de São Paulo |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29133606 | Result | 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. | |
| 30661477 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Laparoscopic Roux-en-Y Gastric Bypass | Laparoscopic Roux-en-Y gastric bypass performed as a treatment for obesity. Laparoscopic Roux-en-Y gastric bypass (LRYGB): Laparoscopic Roux-en-Y gastric bypass (LRYGB)is the one of the techniques of bariatric surgery 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. |
| FG001 | Clinical Treatment | Optimized clinical treatment including medical management of hypertension. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Laparoscopic Roux-en-Y Gastric Bypass | Laparoscopic Roux-en-Y gastric bypass performed as a treatment for obesity. Laparoscopic Roux-en-Y gastric bypass (LRYGB): Laparoscopic Roux-en-Y gastric bypass (LRYGB)is the one of the techniques of bariatric surgery 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 12 months |
|
1 year
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Laparoscopic Roux-en-Y Gastric Bypass | Laparoscopic Roux-en-Y gastric bypass performed as a treatment for obesity. Laparoscopic Roux-en-Y gastric bypass (LRYGB): Laparoscopic Roux-en-Y gastric bypass (LRYGB)is the one of the techniques of bariatric surgery 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rehospitalization | Injury, poisoning and procedural complications | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertensive crisis | Cardiac disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Carlos Schiavon | HCor | 1130536611 | 8201 | schiavon.ca@gmail.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 1, 2014 | Sep 13, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 15, 2016 | Oct 9, 2019 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|
Change on systemic blood pressure assessed by ambulatory blood pressure monitoring (ABPM). |
| 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 | 12, 24, 36, 48 and 60 months |
| Absolute Change From Baseline on Systolic Blood Pressure | Absolute change from baseline in systolic blood pressure | 12, 24, 36, 48 and 60 months |
| Absolute Change From Baseline on Diastolic Blood Pressure | Absolute change from baseline in diastolic blood pressure | 12, 24, 36, 48 and 60 months |
| Absolute Change From Baseline on Weight Loss | Absolute change from baseline on weight loss | 12, 24, 36, 48 and 60 months |
| Absolute Change From Baseline on BMI | Absolute change from baseline on BMI | 12, 24, 36, 48 and 60 months |
| Absolute Change From Baseline on Waist Circumference | Absolute change from baseline on waist circumference | 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 | 12, 24, 36, 48 and 60 months |
| Absolute Change From Baseline on LDL-cholesterol Level | Absolute change from baseline on LDL-cholesterol level | 12, 24, 36, 48 and 60 months |
| Absolute Change From Baseline on HDL-cholesterol Level | Absolute change from baseline on HDL-cholesterol level | 12, 24, 36, 48 and 60 months |
| Absolute Change From Baseline on Triglycerides Levels | Absolute change from baseline on triglycerides levels | 12, 24, 36, 48 and 60 months |
| Absolute Change From Baseline on Uric Acid Levels | Absolute change from baseline on uric acid levels | 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 | 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 | 12, 24, 36, 48 and 60 months |
| Change on Heart Anatomy | Change on heart anatomy as evaluated by echocardiogram | 12, 24, 36, 48 and 60 months |
| Change on Sleep Quality | Change on sleep quality as evaluated by polysomnography | 12, 24, 36, 48 and 60 months |
| Adverse Events | Describe the main adverse events | At any time during the study period |
| São Paulo |
| São Paulo |
| 04004-060 |
| Brazil |
| Hospital do Coração - Research Institute | São Paulo | 04005-000 | Brazil |
| 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. |
| 30679036 | 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. |
| 38325988 | Derived | 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. |
| 32805133 | 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. |
| 25200559 | 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. |
| BG001 | Clinical Treatment | Optimized clinical treatment including medical management of hypertension. 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Anti-hypertensive medications | Median | Inter-Quartile Range | Anti-hypertensive medications |
|
| OG001 |
| Clinical Treatment |
Optimized clinical treatment including medical management of hypertension. 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. |
|
|
| Secondary | 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). | Not Posted | 12, 24, 36, 48 and 60 months | Participants |
| Secondary | Absolute Change From Baseline in Blood Pressure Levels | Change on systemic blood pressure assessed by ambulatory blood pressure monitoring (ABPM). | Not Posted | 12, 24, 36, 48 and 60 months | Participants |
| Secondary | 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 | Not Posted | 12, 24, 36, 48 and 60 months | Participants |
| Secondary | Absolute Change From Baseline on Systolic Blood Pressure | Absolute change from baseline in systolic blood pressure | Not Posted | 12, 24, 36, 48 and 60 months | Participants |
| Secondary | Absolute Change From Baseline on Diastolic Blood Pressure | Absolute change from baseline in diastolic blood pressure | Not Posted | 12, 24, 36, 48 and 60 months | Participants |
| Secondary | Absolute Change From Baseline on Weight Loss | Absolute change from baseline on weight loss | Not Posted | 12, 24, 36, 48 and 60 months | Participants |
| Secondary | Absolute Change From Baseline on BMI | Absolute change from baseline on BMI | Not Posted | 12, 24, 36, 48 and 60 months | Participants |
| Secondary | Absolute Change From Baseline on Waist Circumference | Absolute change from baseline on waist circumference | Not Posted | 12, 24, 36, 48 and 60 months | Participants |
| Secondary | 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 | Not Posted | 12, 24, 36, 48 and 60 months | Participants |
| Secondary | Absolute Change From Baseline on LDL-cholesterol Level | Absolute change from baseline on LDL-cholesterol level | Not Posted | 12, 24, 36, 48 and 60 months | Participants |
| Secondary | Absolute Change From Baseline on HDL-cholesterol Level | Absolute change from baseline on HDL-cholesterol level | Not Posted | 12, 24, 36, 48 and 60 months | Participants |
| Secondary | Absolute Change From Baseline on Triglycerides Levels | Absolute change from baseline on triglycerides levels | Not Posted | 12, 24, 36, 48 and 60 months | Participants |
| Secondary | Absolute Change From Baseline on Uric Acid Levels | Absolute change from baseline on uric acid levels | Not Posted | 12, 24, 36, 48 and 60 months | Participants |
| Secondary | Absolute Change From Baseline on Ultra-sensitive CRP Levels | Absolute change from baseline on ultra-sensitive CRP levels | Not Posted | 12, 24, 36, 48 and 60 months | Participants |
| Secondary | Absolute Change From Baseline of Cardiovascular Risk | Absolute change from baseline of cardiovascular risk calculated by Framingham Score | Not Posted | 12, 24, 36, 48 and 60 months | Participants |
| Secondary | Change on Heart Anatomy | Change on heart anatomy as evaluated by echocardiogram | Not Posted | 12, 24, 36, 48 and 60 months | Participants |
| Secondary | Change on Sleep Quality | Change on sleep quality as evaluated by polysomnography | Not Posted | 12, 24, 36, 48 and 60 months | Participants |
| Secondary | Adverse Events | Describe the main adverse events | Not Posted | At any time during the study period | Participants |
| 0 |
| 49 |
| 6 |
| 49 |
| 0 |
| 49 |
| EG001 | Clinical Treatment | Optimized clinical treatment including medical management of hypertension. 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. | 0 | 47 | 0 | 47 | 1 | 47 |
Not provided
Not provided
| D009748 |
| Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |