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

NCT03008096 | Unknown

• 1 other identifier: LSG-BTC-LVAD
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure; Obesity

Outcome Measures

Primary Outcomes (1)

• BMI (Body-Mass-Index)

  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 Outcomes (8)

• 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

• Work Ability questionnaire

  12 months post-LSG

• WHOQOL-BREF (World Health Organization Quality of Life) questionnaire

  12 months post-LSG

Interventions

Laparoscopic Sleeve Gastrectomy PROCEDURE

Routine Laparoscopic Sleeve Gastrectomy is performed on obese patients supported by Left-Ventricular Assist Device in order to reach a Body Mass Index sufficient for heart transplantation listing.

Also known as: Bariatric Surgery

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Philipp Angleitner: lead

Study Sites (1)

Division of Cardiac Surgery, Medical University of Vienna

Vienna, Vienna, 1090, Austria

RECRUITING

Related Publications (5)

• 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.

  PMID: 26065994 BACKGROUND

• 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.

  PMID: 26454738 BACKGROUND

• 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.

  PMID: 26776864 BACKGROUND

• 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.

  PMID: 26520247 BACKGROUND

• 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.

  PMID: 25105982 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Obesity

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Officials

• Daniel Zimpfer, Priv.-Doz. Dr.

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philipp Angleitner, Dr.

CONTACT

+4314040052620; philipp.angleitner@meduniwien.ac.at

Daniel Zimpfer, Priv.-Doz. Dr.

CONTACT

+4314040052620; daniel.zimpfer@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: December 16, 2016
• First Posted: January 2, 2017
• Study Start: November 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: January 2, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)