Obesity Clinical Trial
Official title:
Laparoscopic Sleeve Gastrectomy as Bridge-to-Candidacy for Obese Left-Ventricular Assist Device Patients
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.
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.
It is unclear, whether laparoscopic sleeve gastrectomy is effective and safe in patients on
CF-LVAD. The literature is limited to case reports and retrospective series of up to 4
patients. This is the first prospective series including more than 4 patients with the
specific aim to enable obese LVAD supported patients to reach a BMI within listing criteria
for heart transplantation by the means of laparoscopic sleeve gastrectomy.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04243317 -
Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults
|
N/A | |
Recruiting |
NCT04101669 -
EndoBarrier System Pivotal Trial(Rev E v2)
|
N/A | |
Terminated |
NCT03772886 -
Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball
|
N/A | |
Completed |
NCT03640442 -
Modified Ramped Position for Intubation of Obese Females.
|
N/A | |
Completed |
NCT04506996 -
Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2
|
N/A | |
Recruiting |
NCT06019832 -
Analysis of Stem and Non-Stem Tibial Component
|
N/A | |
Active, not recruiting |
NCT05891834 -
Study of INV-202 in Patients With Obesity and Metabolic Syndrome
|
Phase 2 | |
Active, not recruiting |
NCT05275959 -
Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI)
|
N/A | |
Recruiting |
NCT04575194 -
Study of the Cardiometabolic Effects of Obesity Pharmacotherapy
|
Phase 4 | |
Completed |
NCT04513769 -
Nutritious Eating With Soul at Rare Variety Cafe
|
N/A | |
Withdrawn |
NCT03042897 -
Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer
|
N/A | |
Completed |
NCT03644524 -
Heat Therapy and Cardiometabolic Health in Obese Women
|
N/A | |
Recruiting |
NCT05917873 -
Metabolic Effects of Four-week Lactate-ketone Ester Supplementation
|
N/A | |
Active, not recruiting |
NCT04353258 -
Research Intervention to Support Healthy Eating and Exercise
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Recruiting |
NCT03227575 -
Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control
|
N/A | |
Completed |
NCT01870947 -
Assisted Exercise in Obese Endometrial Cancer Patients
|
N/A | |
Recruiting |
NCT05972564 -
The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
|
Phase 1/Phase 2 | |
Recruiting |
NCT06007404 -
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
|
||
Recruiting |
NCT05371496 -
Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction
|
Phase 2 |