- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03105726
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
Status
Completed
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C-1421-14-05
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.
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