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

April 25, 2017 updated by: Joe Elie Salem

Medical Care Versus Ventricular Assist Device in Patients With NYHA Class IV Congestive Heart Failure: a Non Randomized Comparison of Clinical and Economic Outcomes

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.

Study Overview

Study Type

Observational

Enrollment (Actual)

224

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: two years
The primary outcome was comparison of survival at two years between the two treatment strategies
two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resource consumption
Time Frame: Two years
One secondary outcomes was comparison of the treatment strategies up to two years of follow-up about resource consumption.
Two years
Costs
Time Frame: Two years
One secondary outcomes was comparison of the treatment strategies up to two years of follow-up about costs.
Two years
Costs versus survival
Time Frame: Two years
One secondary outcomes was comparison of the treatment strategies up to two years of follow-up about costs versus survival.
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: 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;
  • Principal Investigator: Nadia NA Aissaoui, MD, PhD, HEGP and Université Paris Descartes
  • Study Chair: Jan JG Gummert, M.D, PhD, Herz und Diabetes Zentrum, NRW
  • Study Chair: Jean-Yves JYF Fagon, MD, PhD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2010

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

April 4, 2017

First Submitted That Met QC Criteria

April 4, 2017

First Posted (Actual)

April 10, 2017

Study Record Updates

Last Update Posted (Actual)

April 27, 2017

Last Update Submitted That Met QC Criteria

April 25, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Failure

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