Clinical trial NCT01784848: GAstric Bypass to Treat obEse Patients With steAdy hYpertension
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Systemic Hypertension
Obesity
Keywords: high blood pressure
hypertension
bariatric surgery
Laparoscopic Roux-en-Y gastric bypass (LRYGB)
obesity
Lead sponsor: Hospital do Coracao
Sponsor class: OTHER
Collaborators: name: Ethicon Endo-Surgery
First posted: 2013-02-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With a Reduction in the Number of Anti-hypertensive Drugs Used and Maintaining Blood Pressure Below 140x90mmHg
timeFrame: 12 months
Secondary outcomes:
measure: Efficacy of Roux-en-Y Gastroplasty to Decrease the Number of Antihypertensive Drugs.
timeFrame: 12, 24, 36, 48 and 60 months
measure: Absolute Change From Baseline in Blood Pressure Levels
timeFrame: 12, 24, 36, 48 and 60 months
measure: Effect on Central Blood Pressure Augmentation Index and Pulse Wave Velocity
timeFrame: 12, 24, 36, 48 and 60 months
measure: Absolute Change From Baseline on Systolic Blood Pressure
timeFrame: 12, 24, 36, 48 and 60 months
measure: Absolute Change From Baseline on Diastolic Blood Pressure
timeFrame: 12, 24, 36, 48 and 60 months
measure: Absolute Change From Baseline on Weight Loss
timeFrame: 12, 24, 36, 48 and 60 months
measure: Absolute Change From Baseline on BMI
timeFrame: 12, 24, 36, 48 and 60 months
measure: Absolute Change From Baseline on Waist Circumference
timeFrame: 12, 24, 36, 48 and 60 months
measure: Absolute Change From Baseline on Fasting Plasm Glucose Level, HbA1c and Insulin Resistance
timeFrame: 12, 24, 36, 48 and 60 months
measure: Absolute Change From Baseline on LDL-cholesterol Level
timeFrame: 12, 24, 36, 48 and 60 months
measure: Absolute Change From Baseline on HDL-cholesterol Level
timeFrame: 12, 24, 36, 48 and 60 months
measure: Absolute Change From Baseline on Triglycerides Levels
timeFrame: 12, 24, 36, 48 and 60 months
measure: Absolute Change From Baseline on Uric Acid Levels
timeFrame: 12, 24, 36, 48 and 60 months
measure: Absolute Change From Baseline on Ultra-sensitive CRP Levels
timeFrame: 12, 24, 36, 48 and 60 months
measure: Absolute Change From Baseline of Cardiovascular Risk
timeFrame: 12, 24, 36, 48 and 60 months
measure: Change on Heart Anatomy
timeFrame: 12, 24, 36, 48 and 60 months
measure: Change on Sleep Quality
timeFrame: 12, 24, 36, 48 and 60 months
measure: Adverse Events
timeFrame: At any time during the study period
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto Dante Pazzanese de Cardiologia
state: SP
city: São Paulo
country: Brazil
facility: Instituto do Coração - Hospital das Clínicas de São Paulo
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital do Coração - Research Institute
Study officials:
affiliation: Hospital do Coração
name: Carlos A Schiavon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.