N/A
N=100
GAstric Bypass to Treat obEse Patients With steAdy hYpertension
Systemic Hypertension · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT01784848 ↗Enrolled (actual)
100
Serious AEs
6.3%
Results posted
Nov 2019
Primary outcome: Primary: Number of Participants With a Reduction in the Number of Anti-hypertensive Drugs Used and Maintaining Blood Pressure Below 140x90mmHg — 41; 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Laparoscopic Roux-en-Y gastric bypass (LRYGB) (Procedure); Clinical treatment (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hospital do Coracao
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Reduction in the Number of Anti-hypertensive Drugs Used and Maintaining Blood Pressure Below 140x90mmHg |
41; 6 | — |
| SECONDARY Efficacy of Roux-en-Y Gastroplasty to Decrease the Number of Antihypertensive Drugs. |
— | — |
| SECONDARY Absolute Change From Baseline in Blood Pressure Levels |
— | — |
| SECONDARY Effect on Central Blood Pressure Augmentation Index and Pulse Wave Velocity |
— | — |
| SECONDARY Absolute Change From Baseline on Systolic Blood Pressure |
— | — |
| SECONDARY Absolute Change From Baseline on Diastolic Blood Pressure |
— | — |
| SECONDARY Absolute Change From Baseline on Weight Loss |
— | — |
| SECONDARY Absolute Change From Baseline on BMI |
— | — |
| SECONDARY Absolute Change From Baseline on Waist Circumference |
— | — |
| SECONDARY Absolute Change From Baseline on Fasting Plasm Glucose Level, HbA1c and Insulin Resistance |
— | — |
| SECONDARY Absolute Change From Baseline on LDL-cholesterol Level |
— | — |
| SECONDARY Absolute Change From Baseline on HDL-cholesterol Level |
— | — |
| SECONDARY Absolute Change From Baseline on Triglycerides Levels |
— | — |
| SECONDARY Absolute Change From Baseline on Uric Acid Levels |
— | — |
| SECONDARY Absolute Change From Baseline on Ultra-sensitive CRP Levels |
— | — |
| SECONDARY Absolute Change From Baseline of Cardiovascular Risk |
— | — |
| SECONDARY Change on Heart Anatomy |
— | — |
| SECONDARY Change on Sleep Quality |
— | — |
| SECONDARY Adverse Events |
— | — |
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.
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 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.
Data sourced from ClinicalTrials.gov (NCT01784848). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.