GAstric Bypass to Treat obEse Patients With steAdy hYpertension

Not Applicable

Completed

Conditions: Systemic Hypertension
Obesity

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

Registration Number: NCT01784848

Lead Sponsor: Hospital do Coracao

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.

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 100

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopic Roux-en-Y gastric bypass	Clinical treatment	Laparoscopic Roux-en-Y gastric bypass performed as a treatment for obesity.
Laparoscopic Roux-en-Y gastric bypass	Laparoscopic Roux-en-Y gastric bypass (LRYGB)	Laparoscopic Roux-en-Y gastric bypass performed as a treatment for obesity.
Clinical treatment	Clinical treatment	Optimized clinical treatment including medical management of hypertension.

Primary Outcome Measures

Name	Time	Method
Number of Participants With a Reduction in the Number of Anti-hypertensive Drugs Used and Maintaining Blood Pressure Below 140x90mmHg	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

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

Trial Locations

Locations (3): Instituto Dante Pazzanese de Cardiologia
🇧🇷
São Paulo, SP, Brazil
Instituto do Coração - Hospital das Clínicas de São Paulo
🇧🇷
São Paulo, SP, Brazil
Hospital do Coração - Research Institute
🇧🇷
Sao Paulo, Brazil