Hemodynamic Changes and Vascular Tone Control After Bariatric Surgery. Prognostic Value Regarding Hypertension and Target Organ Damage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Mean changes 24h-aortic systolic-blood pressure (SBP) measured in mmHg
研究概览
简要总结
Obese patients have increased cardiovascular risk and target organ damage (TOD) as compared to people with normal weight. Weight loss reduces cardiovascular risk and TOD. These changes have been associated mainly to changes in inflammatory and pro-atherogenic markers. Office peripheral blood pressure (BP) appears to decrease after bariatric surgery, but information on changes in 24h-ambulatory-BP-monitoring (24h-ABPM) and central-BP(cBP), or about the possible role of renin-angiotensin-aldosterone (RAAS), serotonin(STS) and endocannabinoid(ECS) systems is scarce. Our hypothesis is that the hemodynamic changes mediated by alterations in the RAAS, STS and ECS after weight loss are also responsible for the reduction of TOD.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 - 65 years,
- •who have medical indication for treatment with bariatric surgery and agreeing to undergo the intervention,with
- •given informed consent
排除标准
- •Unmeeting the above Inclusion Criteria.
结局指标
主要结局
Mean changes 24h-aortic systolic-blood pressure (SBP) measured in mmHg
时间窗: From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.
次要结局
- Mean changes in peripheral- 24h, daytime and nighttime blood pressure estimates measured in mmHg(From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.)
- Mean change in arterial stiffness parameters (I)(From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.)
- Mean change in Left atrium diameter(From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.)
- Mean changes in aortic- 24h, daytime and nighttime blood pressure estimates others than 24h systolic blood pressure measured in mmHg(From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.)
- Mean change in office blood pressure estimates measured in mmHg(From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.)
- Mean change in left ventricular remodeling index(From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.)
- Mean change in the serotonergic system components(From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.)
- Mean change in arterial stiffness parameters (II)(From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.)
- Mean change in Left ventricular mass index(From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.)
- Mean change in Ejection fraction(From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.)
- Mean change in carotid intima-media thickness measured in mm(From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.)
- Mean change in biochemical parameters measured in mg/dl or mmol/L(From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.)
- Mean change in the components of the renin-angiotensin system(From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.)
- Mean change in the components of the endocannabinoid system(From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.)
- Mean change in pro-atherosclerotic markers(From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.)
研究者
Anna Oliveras
Head of Hypertension & Vascular Risk Unit. Nephrology Department
Parc de Salut Mar