- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03008096
Laparoscopic Sleeve Gastrectomy as Bridge-to-Candidacy for Obese Left-Ventricular Assist Device Patients (LSG-BTC-LVAD)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Philipp Angleitner, Dr.
- Phone Number: +4314040052620
- Email: philipp.angleitner@meduniwien.ac.at
Study Contact Backup
- Name: Daniel Zimpfer, Priv.-Doz. Dr.
- Phone Number: +4314040052620
- Email: daniel.zimpfer@meduniwien.ac.at
Study Locations
-
-
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Vienna, Austria, 1090
- Recruiting
- Division of Cardiac Surgery, Medical University of Vienna
-
Contact:
- Philipp Angleitner, Dr.
- Phone Number: +4314040052620
- Email: philipp.angleitner@meduniwien.ac.at
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Absolute contraindications to subsequent heart transplantation other than obesity
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BMI (Body-Mass-Index)
Time Frame: 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.
|
12 months post-LSG
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
NYHA (New York Heart Association) Class
Time Frame: 12 months post-LSG
|
Patients' NYHA Class (I, II, IIIa, IIIb, IV) is assessed pre-operatively and at 3, 6, and 12 months post-LSG and changes are noted.
|
12 months post-LSG
|
6-min Walking Test
Time Frame: 12 months post-LSG
|
Patients are performing the 6-min walking test pre-operatively and at 3, 6, and 12 months post-LSG and changes of the distance walked (m) are assessed.
|
12 months post-LSG
|
EQ-5D (EuroQol five dimensions) questionnaire
Time Frame: 12 months post-LSG
|
Patients are undertaking the EQ-5D quality-of-life questionnaire (mobility, self care, usual activities, pain/discomfort, anxiety/depression, and visual analog scale) pre-operatively and at 3, 6, and 12 months post-LSG to assess changes in the post-operative quality of life.
|
12 months post-LSG
|
Work Ability questionnaire
Time Frame: 12 months post-LSG
|
Patients are undertaking the Work Ability questionnaire including questions about their current or former occupation pre-operatively and at 3, 6, and 12 months post-LSG to assess changes in occupational issues.
|
12 months post-LSG
|
WHOQOL-BREF (World Health Organization Quality of Life) questionnaire
Time Frame: 12 months post-LSG
|
Patients are undertaking the WHOQOL-BREF questionnaire including questions regarding their quality of life pre-operatively and at 3, 6, and 12 months post-LSG to assess changes regarding social, emotional, and health-related issues.
|
12 months post-LSG
|
LVEF (Left-Ventricular Ejection Fraction)
Time Frame: 12 months post-LSG
|
LVEF (%) is going to be measured by echocardiography pre-operatively and at 3, 6, and 12 months post-LSG to investigate changes of cardiac function.
|
12 months post-LSG
|
VO2 max (maximum rate of oxygen consumption)
Time Frame: 12 months post-LSG
|
Patients are undergoing spiroergometry pre-operatively and at 3, 6, and 12 months post-LSG to investigate changes of cardiac performance.
|
12 months post-LSG
|
Severe adverse events
Time Frame: 12 months post-LSG
|
Adverse and severe adverse events including death, unplanned hospital readmission, reoperation, major bleeding, cardiac arrhythmia, pericardial fluid collection, device malfunction, hemolysis, hepatic dysfunction, hypertension, major infection, myocardial infarction, neurological dysfunction, psychiatric episodes, renal dysfunction, respiratory failure, right heart failure, arterial non-CNS (central nervous system) thromboembolism, venous thromboembolism, wound dehiscence, gastroesophageal reflux disease, vomiting, gastric anastomotic leak, trocar site infection, trocar site hernia, gastric pouch dilation, and others are assessed in the immediately post-operative phase and at 3, 6, and 12 months post-LSG.
|
12 months post-LSG
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Daniel Zimpfer, Priv.-Doz. Dr., Medical University of Vienna
Publications and helpful links
General Publications
- Lund LH, Edwards LB, Kucheryavaya AY, Benden C, Dipchand AI, Goldfarb S, Levvey BJ, Meiser B, Rossano JW, Yusen RD, Stehlik J. The Registry of the International Society for Heart and Lung Transplantation: Thirty-second Official Adult Heart Transplantation Report--2015; Focus Theme: Early Graft Failure. J Heart Lung Transplant. 2015 Oct;34(10):1244-54. doi: 10.1016/j.healun.2015.08.003. Epub 2015 Aug 28. No abstract available.
- Colquitt JL, Pickett K, Loveman E, Frampton GK. Surgery for weight loss in adults. Cochrane Database Syst Rev. 2014 Aug 8;2014(8):CD003641. doi: 10.1002/14651858.CD003641.pub4.
- Mancini D, Colombo PC. Left Ventricular Assist Devices: A Rapidly Evolving Alternative to Transplant. J Am Coll Cardiol. 2015 Jun 16;65(23):2542-55. doi: 10.1016/j.jacc.2015.04.039.
- Mehra MR, Canter CE, Hannan MM, Semigran MJ, Uber PA, Baran DA, Danziger-Isakov L, Kirklin JK, Kirk R, Kushwaha SS, Lund LH, Potena L, Ross HJ, Taylor DO, Verschuuren EAM, Zuckermann A; International Society for Heart Lung Transplantation (ISHLT) Infectious Diseases, Pediatric and Heart Failure and Transplantation Councils. The 2016 International Society for Heart Lung Transplantation listing criteria for heart transplantation: A 10-year update. J Heart Lung Transplant. 2016 Jan;35(1):1-23. doi: 10.1016/j.healun.2015.10.023. No abstract available.
- Kirklin JK, Naftel DC, Pagani FD, Kormos RL, Stevenson LW, Blume ED, Myers SL, Miller MA, Baldwin JT, Young JB. Seventh INTERMACS annual report: 15,000 patients and counting. J Heart Lung Transplant. 2015 Dec;34(12):1495-504. doi: 10.1016/j.healun.2015.10.003. Epub 2015 Oct 8.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LSG-BTC-LVAD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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