- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03008096
Laparoscopic Sleeve Gastrectomy as Bridge-to-Candidacy for Obese Left-Ventricular Assist Device Patients (LSG-BTC-LVAD)
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Vienna, Østerrike, 1090
- Rekruttering
- Division of Cardiac Surgery, Medical University of Vienna
-
Ta kontakt med:
- Philipp Angleitner, Dr.
- Telefonnummer: +4314040052620
- E-post: philipp.angleitner@meduniwien.ac.at
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
BMI (Body-Mass-Index)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
NYHA (New York Heart Association) Class
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Daniel Zimpfer, Priv.-Doz. Dr., Medical University of Vienna
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- LSG-BTC-LVAD
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Hjertefeil
-
Istanbul UniversityHar ikke rekruttert ennåTidlig mobilisering, Open-Heart Surgery, Virtual RealityTyrkia
-
Region SkanePåmelding etter invitasjonHjertesvikt New York Heart Association (NYHA) klasse II | Hjertesvikt New York Heart Association (NYHA) klasse IIISverige
-
Medical University of BialystokMedical University of Lodz; Poznan University of Medical Sciences; Nicolaus... og andre samarbeidspartnereAvsluttetHjertesvikt, systolisk | Hjertesvikt med redusert utkastningsfraksjon | Hjertesvikt New York Heart Association Klasse IV | Hjertesvikt New York Heart Association klasse IIIPolen
-
Luigi Sacco University HospitalIRCCS Azienda Ospedaliero-Universitaria di Bologna; University of Padova; Università degli Studi di Ferrara og andre samarbeidspartnereRekrutteringAtrieflimmer | Block Complete HeartItalia, Belgia, Sveits
-
University of WashingtonAmerican Heart AssociationFullførtHjertesvikt, Kongestiv | Mitokondriell endring | Hjertesvikt New York Heart Association Klasse IVForente stater
-
Portuguese Association of Interventional CardiologyMedtronicRekrutteringAlvorlig symptomatisk aortastenose (definert som New York Heart Association (NYHA) klasse ≥ II)Portugal
-
Novartis PharmaceuticalsFullførtPasienter som har fullført den 12-måneders behandlingsperioden i kjernestudien (de Novo Heart-mottakere) som var interessert i å bli behandlet med EC-MPS
-
University Hospital, GasthuisbergUkjentTransient Left Ventricular Ballooning SyndromeBelgia
-
NYU Langone HealthRekrutteringTako-tsubo kardiomyopati | Takotsubo kardiomyopati | Broken Heart SyndromeForente stater
-
French Cardiology SocietyFullført
Kliniske studier på Laparoscopic Sleeve Gastrectomy
-
Bambino Gesù Hospital and Research InstituteFullførtNAFLD | Sykelig fedme
-
Instituto de Investigación Marqués de ValdecillaRekrutteringIkke-alkoholisk Steatohepatitt (NASH)Spania
-
Tel-Aviv Sourasky Medical CenterFullførtVekttap | Lever Steatose | LeverfibroseIsrael
-
ARKSurgicalUkjent
-
North Shore Hospital, New ZealandFullførtOvervekt | Type 2 diabetes mellitusNew Zealand
-
University Hospital of FerraraFullførtKirurgi | Rektal prolaps | Avføringsforstyrrelse | Rectocele; HunnItalia
-
King Saud UniversityNew You Medical CenterFullførtKandidat for fedmekirurgi | Fedme, barndom | Kardiovaskulær risikofaktorSaudi-Arabia
-
Fudan UniversityUkjentAdenokarsinom i Esophagogastric Junction.Kina
-
Ricard CorcellesRekrutteringLivskvalitet | Overvekt | Kandidat for fedmekirurgi | Postoperativ smerte | Laparoskopisk sleeve gastrectomy | Robotic Sleeve GastrectomyForente stater