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GAstric Bypass to Treat obEse Patients With steAdy hYpertension (GATEWAY)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Ethicon Endo-Surgery
Information provided by (Responsible Party):
Hospital do Coracao
ClinicalTrials.gov Identifier:
NCT01784848
First received: February 4, 2013
Last updated: May 30, 2016
Last verified: May 2016
  Purpose
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.

Condition Intervention Phase
Systemic Hypertension
Obesity
Procedure: Laparoscopic Roux-en-Y gastric bypass (LRYGB)
Other: Clinical treatment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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.

Further study details as provided by Hospital do Coracao:

Primary Outcome Measures:
  • Efficacy of Roux-en-Y Gastroplasty to decrease the number of antihypertensive drugs. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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:
  • Efficacy of Roux-en-Y Gastroplasty to decrease the number of antihypertensive drugs. [ Time Frame: 24, 36, 48 and 60 months ] [ Designated as safety issue: No ]
    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 in blood pressure levels [ Time Frame: 12, 24, 36, 48 and 60 months ] [ Designated as safety issue: No ]
    Change on systemic blood pressure assessed by ambulatory blood pressure monitoring (ABPM).

  • Effect on central blood pressure augmentation index and pulse wave velocity [ Time Frame: 12, 24, 36, 48 and 60 months ] [ Designated as safety issue: No ]
    Change on central blood pressureaugmentation index and pulse wave velocity as measured by SphygmoCor device

  • Absolute change from baseline on systolic blood pressure [ Time Frame: 12, 24, 36, 48 and 60 months ] [ Designated as safety issue: No ]
    Absolute change from baseline in systolic blood pressure

  • Absolute change from baseline on diastolic blood pressure [ Time Frame: 12, 24, 36, 48 and 60 months ] [ Designated as safety issue: No ]
    Absolute change from baseline in diastolic blood pressure

  • Absolute change from baseline on weight loss and BMI [ Time Frame: 12, 24, 36, 48 and 60 months ] [ Designated as safety issue: No ]
    Absolute change from baseline on weight loss and BMI

  • Absolute change from baseline on waist circumference [ Time Frame: 12, 24, 36, 48 and 60 months ] [ Designated as safety issue: No ]
    Absolute change from baseline on waist circumference

  • Absolute change from baseline on fasting plasm glucose level, HbA1c and insulin resistance [ Time Frame: 12, 24, 36, 48 and 60 months ] [ Designated as safety issue: No ]
    Change from baseline on fasting plasm glucose level, HbA1c and insulin resistance

  • Absolute change from baseline on LDL-cholesterol level [ Time Frame: 12, 24, 36, 48 and 60 months ] [ Designated as safety issue: No ]
    Absolute change from baseline on LDL-cholesterol level

  • Absolute change from baseline on HDL-cholesterol level [ Time Frame: 12, 24, 36, 48 and 60 months ] [ Designated as safety issue: No ]
    Absolute change from baseline on HDL-cholesterol level

  • Absolute change from baseline on triglycerides levels [ Time Frame: 12, 24, 36, 48 and 60 months ] [ Designated as safety issue: No ]
    Absolute change from baseline on triglycerides levels

  • Absolute change from baseline on uric acid levels [ Time Frame: 12, 24, 36, 48 and 60 months ] [ Designated as safety issue: No ]
    Absolute change from baseline on uric acid levels

  • Absolute change from baseline on ultra-sensitive CRP levels [ Time Frame: 12, 24, 36, 48 and 60 months ] [ Designated as safety issue: No ]
    Absolute change from baseline on ultra-sensitive CRP levels

  • Absolute change from baseline of cardiovascular risk [ Time Frame: 12, 24, 36, 48 and 60 months ] [ Designated as safety issue: No ]
    Absolute change from baseline of cardiovascular risk calculated by Framingham Score

  • Change on heart anatomy [ Time Frame: 12, 24, 36, 48 and 60 months ] [ Designated as safety issue: No ]
    Change on heart anatomy as evaluated by echocardiogram

  • Change on sleep quality [ Time Frame: 12, 24, 36, 48 and 60 months ] [ Designated as safety issue: No ]
    Change on sleep quality as evaluated by polissonography

  • Adverse events [ Time Frame: At any time during the study period ] [ Designated as safety issue: Yes ]
    Describe the main adverse events


Estimated Enrollment: 100
Study Start Date: January 2013
Estimated Study Completion Date: May 2021
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Laparoscopic Roux-en-Y gastric bypass
Laparoscopic Roux-en-Y gastric bypass performed as a treatment for obesity.
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 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: Clinical treatment
Optimized clinical treatment including medical management of hypertension.
Other: 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.

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 (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
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01784848

Locations
Brazil
Instituto Dante Pazzanese de Cardiologia
São Paulo, SP, Brazil, 04004-060
Instituto do Coração - Hospital das Clínicas de São Paulo
São Paulo, SP, Brazil, 04004-060
Hospital do Coração - Research Institute
Sao Paulo, Brazil, 04005-000
Sponsors and Collaborators
Hospital do Coracao
Ethicon Endo-Surgery
Investigators
Principal Investigator: Carlos A Schiavon, MD, PhD Hospital do Coração
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hospital do Coracao
ClinicalTrials.gov Identifier: NCT01784848     History of Changes
Other Study ID Numbers: IEP2013_HAS 
Study First Received: February 4, 2013
Last Updated: May 30, 2016
Health Authority: Brazil: National Committee of Ethics in Research
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Hospital do Coracao:
high blood pressure
hypertension
bariatric surgery
Laparoscopic Roux-en-Y gastric bypass (LRYGB)
obesity

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 30, 2016