GAstric Bypass to Treat obEse Patients With steAdy hYpertension
GAstric Bypass to Treat obEse Patients With steAdy hYpertension
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 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
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.