Overview

This trial is active, not recruiting.

Conditions systemic hypertension, obesity
Treatments laparoscopic roux-en-y gastric bypass (lrygb), clinical treatment
Phase phase 3
Sponsor Hospital do Coracao
Collaborator Ethicon Endo-Surgery
Start date January 2013
End date May 2017
Trial size 100 participants
Trial identifier NCT01784848, IEP2013_HAS

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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.
(Active Comparator)
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.

Primary Outcomes

Measure
Efficacy of Roux-en-Y Gastroplasty to decrease the number of antihypertensive drugs.
time frame: 12 months

Secondary Outcomes

Measure
Efficacy of Roux-en-Y Gastroplasty to decrease the number of antihypertensive drugs.
time frame: 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 and 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

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.

Additional Information

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.
Principal investigator Carlos A Schiavon, MD, PhD
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 (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®) - Polissonography - Anthropometry - Nutritional survey - Laboratory tests - Echocardiogram - Electrocardiogram - Abdominal ultrasound - Upper gastrointestinal endoscopy with H.pilory testing
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Hospital do Coracao.