Heart FailureMEVADENCT03105726
Medical Care Versus Ventricular Assist Device for the Management of End-stage Heart Failure (MEVADE)
An observational study of Heart Failure and Heart Transplantation, run by Joe Elie Salem.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 76 years
- Conditions the study is for
- Heart Failure, Heart Transplantation, Heart-Assist Devices
- How many people
- 224 participants
- Where
- No sites listed yet
- Study dates
- Nov 2010to Jan 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- 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
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- 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
About this study
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
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
- Medical subject headings
- Heart Failure, Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Survival
The primary outcome was comparison of survival at two years between the two treatment strategies
Measured: two years
Secondary outcomes (3)
Resource consumption
One secondary outcomes was comparison of the treatment strategies up to two years of follow-up about resource consumption.
Measured: Two years
Costs
One secondary outcomes was comparison of the treatment strategies up to two years of follow-up about costs.
Measured: Two years
Costs versus survival
One secondary outcomes was comparison of the treatment strategies up to two years of follow-up about costs versus survival.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study startNov 2010
- Primary completionOct 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joe Elie Salem
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joe Elie Salem, Groupe Hospitalier Pitie-Salpetriere
- Investigators
- Isabelle IDZ Durand-Zaleski, MD, PhD, Study director, UMRS 1123, Unité de Recherche Clinique en Économie de la Santé, Ile de France Hôpital Hôtel Dieu, Santé Publique Hôpital Henri Mondor, Paris, France;Nadia NA Aissaoui, MD, PhD, Principal investigator, HEGP and Université Paris DescartesJan JG Gummert, M.D, PhD, Study chair, Herz und Diabetes Zentrum, NRWJean-Yves JYF Fagon, MD, PhD, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105726
- Sponsor's protocol ID
- C-1421-14-05
- Acronym
- MEVADE
- Status last verified
- Apr 2017
- First submitted
- 4 Apr 2017
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03105726
- Acronym / sponsor ID
- MEVADE / C-1421-14-05
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Joe Elie SalemUniversity, hospital or other
- Study start
- Nov 2010 (actual)
- Primary completion
- Oct 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 10 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (17 listed)
- Age over 70 years
- Active neoplasia
- Suspected or active systemic infection
- Body mass index ≥40 kg/m2
- Severe chronic obstruction pulmonary disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival
Time frame: two years
The primary outcome was comparison of survival at two years between the two treatment strategies
3 secondary outcomes
Resource consumption
Time frame: Two years
Costs
Time frame: Two years
Costs versus survival
Time frame: Two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle IDZ Durand-Zaleski, MD, PhD study director
UMRS 1123, Unité de Recherche Clinique en Économie de la Santé, Ile de France Hôpital Hôtel Dieu, Santé Publique Hôpital Henri Mondor, Paris, France;
Nadia NA Aissaoui, MD, PhD principal investigator
HEGP and Université Paris Descartes
Jan JG Gummert, M.D, PhD study chair
Herz und Diabetes Zentrum, NRW
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Heart Transplantation, run by Joe Elie Salem.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2017.