Clinical trial NCT03105726: Medical Care Versus Ventricular Assist Device for the Management of End-stage Heart Failure (MEVADE)
Official title: Medical Care Versus Ventricular Assist Device in Patients With NYHA Class IV Congestive Heart Failure: a Non Randomized Comparison of Clinical and Economic Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Groupe Hospitalier Pitie-Salpetriere
Sponsor class: OTHER
First posted: 2017-04-10
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: Inclusion Criteria: All patients presenting with end-stage heart failure defined as:

* 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

Primary outcomes:
measure: Survival
timeFrame: two years
Secondary outcomes:
measure: Resource consumption
timeFrame: Two years
measure: Costs
timeFrame: Two years
measure: Costs versus survival
timeFrame: Two years
Other outcomes:
Locations:
Study officials:
affiliation: UMRS 1123, Unité de Recherche Clinique en Économie de la Santé, Ile de France Hôpital Hôtel Dieu, Santé Publique Hôpital Henri Mondor, Paris, France;
name: Isabelle IDZ Durand-Zaleski, MD, PhD
role: STUDY_DIRECTOR
affiliation: HEGP and Université Paris Descartes
name: Nadia NA Aissaoui, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Herz und Diabetes Zentrum, NRW
name: Jan JG Gummert, M.D, PhD
role: STUDY_CHAIR
name: Jean-Yves JYF Fagon, MD, PhD
role: STUDY_CHAIR
References: