Medical Care Versus Ventricular Assist Device for the Management of End-stage Heart Failure (MEVADE)

NCT ID: NCT03105726

Last Updated: 2017-04-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 224 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2014-01-31

Brief Summary

End-stage heart failure (ESHF) represents a major burden in terms of quality of life, mortality and costs. The current practice in France is to treat patients with ESHF by a combination of drugs and lifestyle interventions before proposing heart transplant (HT) if there is no contraindication. In the Heart and Diabetes Center of Bad Oyenhausen (BO) in Germany, patients presenting with ESHF are preferentially managed by ventricular assist device (VAD) therapy. The primary purpose of this study was to compare the outcomes of these two strategies in the management of ESHF and associated consumption of resources.

Conditions

Heart Failure; Heart Transplantation; Heart-Assist Devices

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group I

Group managed by ventricular assist devices in first intention in Bad-Oeynhausen, Germany

No interventions assigned to this group

Group II

Group managed with medical therapy, heart transplantation, or both, in first intention,in Paris, France

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• A left ventricular ejection fraction ≤25%
• Or an oxygen consumption peak < 14 mL/kg/min
• Or severe symptoms (NYHA class III or IV) despite optimal medical treatment
• Or a cardiogenic shock

Exclusion Criteria

• Age over 70 years
• Active neoplasia
• Suspected or active systemic infection
• Body mass index ≥40 kg/m2
• Severe chronic obstruction pulmonary disease
• Evidence of intrinsic hepatic diseases defined as liver enzyme values ≥ 5 times the upper limit of normal within 4 days before the randomisation, or biopsy proven liver cirrhosis
• Significant chronic renal impairment with persistent creatinine >2.5 or clearance < 25ml/min
• Pregnant or lactating female
• Patient under consideration for conventional revascularization procedures, therapeutic valvular repair, left ventricular procedure or cardiomyoplasty
• Presence of implanted mechanical aortic valve that will not be converted to bioprothesis at the time of ventricular assist device implantation
• Evidence of intrinsic hepatic diseases defined as liver enzyme values ≥ 5 times the upper limit of normal, or biopsy proven liver cirrhosis
• Occurrence of stroke within 90 days or history of cerebrovascular disease with major (≥ 80%) extracranial or carotid stenosis documented by Doppler study
• Confirmation by neurologist of impairment of cognitive function, presence of Alzheimer's disease or any other form of irreversible dementia or both
• Major peripheral vascular disease accompanied by pain on rest or leg ulceration
• Recent history of psychiatric disease that is likely to impair compliance
• Drug or alcohol dependence
• Difficult social surroundings

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 76 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Joe Elie Salem

OTHER

Sponsor Role: lead

Responsible Party

Joe Elie Salem

MD, PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Isabelle IDZ Durand-Zaleski, MD, PhD

Role: STUDY_DIRECTOR

UMRS 1123, Unité de Recherche Clinique en Économie de la Santé, Ile de France Hôpital Hôtel Dieu, Santé Publique Hôpital Henri Mondor, Paris, France;

Nadia NA Aissaoui, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

HEGP and Université Paris Descartes

Jan JG Gummert, M.D, PhD

Role: STUDY_CHAIR

Herz und Diabetes Zentrum, NRW

Jean-Yves JYF Fagon, MD, PhD

Role: STUDY_CHAIR

Other Identifiers

C-1421-14-05

Identifier Type: -

Identifier Source: org_study_id