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

NCT03105726 | Completed

• 1 other identifier: C-1421-14-05
• Study Type: observational
• Target: 224
• Locations: 0 countries
• Sites: N/A

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

Keywords

End Stage Heart Failure; New York Heart Association functional class III or IV; Heart transplantation; Ventricular assisted devices; Cardiogenic shock

Outcome Measures

Primary Outcomes (1)

• Survival

  The primary outcome was comparison of survival at two years between the two treatment strategies

  two years

Secondary Outcomes (3)

• Resource consumption

  Two years

• Costs

  Two years

• Costs versus survival

  Two years

Study Arms (2)

Group I

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

Group II

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

Eligibility Criteria

• Age: 18 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients presenting with end-stage heart failure between November 2010 and October 2011 at the Heart and Diabetes Center of Bad Oeynhausen, and who underwent ventricular assist device implantations were included in group I. All patients presenting with end-stage heart failure to the Hôpital Européen Georges Pompidou or the Groupe Hospitalier Pitié-Salpêtrière, during that same period, were included in group II.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Joe Elie Salem: lead

MeSH Terms

Conditions

Heart Failure; Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Myocardial Infarction; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Officials

• Isabelle IDZ Durand-Zaleski, MD, PhD

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

  STUDY DIRECTOR

• Nadia NA Aissaoui, MD, PhD

  HEGP and Université Paris Descartes

  PRINCIPAL INVESTIGATOR

• Jan JG Gummert, M.D, PhD

  Herz und Diabetes Zentrum, NRW

  STUDY CHAIR

• Jean-Yves JYF Fagon, MD, PhD

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 4, 2017
• First Posted: April 10, 2017
• Study Start: November 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: January 1, 2014
• Last Updated: April 27, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share