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临床试验/NCT03008096
NCT03008096Unknown不适用

Laparoscopic Sleeve Gastrectomy as Bridge-to-Candidacy for Obese Left-Ventricular Assist Device Patients

Philipp Angleitner1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2016年11月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
10
试验地点
1
主要终点
BMI (Body-Mass-Index)

研究概览

简要总结

In LVAD (Left-Ventricular Assist Device) patients, evidence is lacking regarding the safety and efficacy of Laparoscopic Sleeve Gastrectomy (LSG) as a means to reach a Body Mass Index (BMI) within listing criteria for heart transplantation. To our knowledge, this is the first prospective study to evaluate laparoscopic sleeve gastrectomy in LVAD patients as bridge-to-candidacy for heart transplantation.

详细描述

Continuous-flow left-ventricular assist devices are increasingly used for the treatment of acute or chronic end-stage heart failure (Mancini 2015). Three main implantation strategies exist: destination therapy (support until end of life), bridge to transplantation (support until transplantation), and bridge to candidacy (support until transplantation criteria are met). Although LVAD support delivers excellent short-term and long-term results, the current gold standard and last resort of treatment for end-stage heart failure remains orthotopic heart transplantation (Lund 2015).

Obesity increases mortality in heart transplantat recipients and therefore is included in the 2006 transplantation criteria. The heart transplant program of the Medical University of Vienna uses a BMI of 30 kg/m2 as the upper limit to be listed for heart transplantation (Mehra 2016).

Ambulatory patients on CF-LVAD support have a tendency to gain weight because of reduced physical fitness, inability to work, and genetic predisposition. In many cases, binge eating is used as a coping mechanism to alleviate depression and anxiety associated with heart failure and LVAD therapy.

Conservative measures to reduce weight and increase physical fitness fail in many patients. As a result, in many cases these patients remain ineligible for heart transplantation for months or years. For the entire period of ineligibility, they are subject to the constant life-threatening risks of LVAD treatment, most importantly ischemic and hemorrhagic stroke, pump thrombosis, infection, right heart failure, and bleeding episodes in the gastrointestinal tract or other organ systems (Kirklin 2015).

Bariatric surgery has been shown to be superior to conservative measures of weight reduction in morbidly obese patients. Laparoscopic sleeve gastrectomy, one of the most commonly employed bariatric procedures, reduces body weight by a non-malabsorptive mechanism (Colquitt 2014). Gastric volume reduction is achieved by resection along the stomach's greater curvature and creation of a gastric tube, leading to reduced capacity for ingested food, decreased appetite and earlier satiety. In contrast to malabsorptive bariatric procedures, resorption and efficacy of immunosuppressive drugs, an inevitable feature of post-transplant therapy, are only minimally influenced following sleeve gastrectomy. Furthermore, there is less requirement for substitution of trace elements and vitamins, for example Vitamin B12. Due to the fact that the majority of obese LVAD patients are within a BMI range of 30 to 40 kg/m2, the moderate weight loss achieved by sleeve gastrectomy is expected to be sufficient for reaching the eligibility criterion for heart transplantation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Ambulatory patients on LVAD-support for end-stage heart failure
  • •Bridge-to-Candidacy strategy
  • •BMI > 35kg/m2
  • •Failure to reach BMI < 30kg/m2 with conservative measures
  • •Age > 18 years
  • •Ability to give informed consent

排除标准

  • •- Absolute contraindications to subsequent heart transplantation other than obesity

结局指标

主要结局

BMI (Body-Mass-Index)

时间窗: 12 months post-LSG

Patient weight is measured and BMI is calculated at the time of LSG and at 3, 6, and 12 months post-LSG. The rate of patients with successful weight reduction to a BMI lower than 30kg/m2 is calculated.

次要结局

  • WHOQOL-BREF (World Health Organization Quality of Life) questionnaire(12 months post-LSG)
  • Work Ability questionnaire(12 months post-LSG)
  • NYHA (New York Heart Association) Class(12 months post-LSG)
  • 6-min Walking Test(12 months post-LSG)
  • EQ-5D (EuroQol five dimensions) questionnaire(12 months post-LSG)
  • LVEF (Left-Ventricular Ejection Fraction)(12 months post-LSG)
  • VO2 max (maximum rate of oxygen consumption)(12 months post-LSG)
  • Severe adverse events(12 months post-LSG)

研究者

发起方
Philipp Angleitner
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Philipp Angleitner

Resident

Medical University of Vienna

研究点 (1)

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