Systemic Hypertension | GAstric Bypass to Treat obEse Patients With steAdy hYpertension
Systemic Hypertension research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Procedure:Laparoscopic Roux-en-Y gastric bypass (LRYGB)Laparoscopic Roux-en-Y gastric bypass (LRYGB)is the one of the techniques of bariatric surgery
Other: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.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Laparoscopic Roux-en-Y gastric bypassLaparoscopic Roux-en-Y gastric bypass performed as a treatment for obesity.
Clinical treatmentOptimized clinical treatment including medical management of hypertension.
Active, not recruiting
Start Date: May 2013
Completed Date: May 2021
Primary Outcome: Efficacy of Roux-en-Y Gastroplasty to decrease the number of antihypertensive drugs.
Secondary Outcome: Efficacy of Roux-en-Y Gastroplasty to decrease the number of antihypertensive drugs.
Study sponsors, principal investigator, and references
Principal Investigator: Carlos A Schiavon, MD, PhD
Lead Sponsor: Hospital do Coracao
Collaborator: Ethicon Endo-Surgery