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GAstric Bypass to Treat obEse Patients With steAdy hYpertension

NCT01784848 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-04-07

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Ethicon Endo-Surgery

    collaborator INDUSTRY

  • Hospital do Coracao

    lead OTHER

Principal Investigators

  • Carlos A Schiavon, MD, PhD · Hospital do Coração

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2017-05-31
Completion
2022-02-28

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01784848 on ClinicalTrials.gov