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

Completed

• Conditions: Heart-Assist Devices; Heart Transplantation; Heart Failure

• Registration Number: NCT03105726
• Lead Sponsor: Joe Elie Salem

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Primary Completion: 2013-10
• Study Completion: 2014-01
• Status Verified: 2017-04
• Study First Submitted: 2017-04-04
• Study First Submitted QC: 2017-04-04
• Study First Posted: 2017-04-10
• Last Update Submitted: 2017-04-25
• Last Update Posted: 2017-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 224

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival	two years	The primary outcome was comparison of survival at two years between the two treatment strategies

Secondary Outcome Measures

Name	Time	Method
Resource consumption	Two years	One secondary outcomes was comparison of the treatment strategies up to two years of follow-up about resource consumption.
Costs	Two years	One secondary outcomes was comparison of the treatment strategies up to two years of follow-up about costs.
Costs versus survival	Two years	One secondary outcomes was comparison of the treatment strategies up to two years of follow-up about costs versus survival.