Heart FailurePhase 4NCT00402376
Evaluation of Myocardial Improvement in Patients Supported by Ventricular Assist Device Under Optimal Pharmacological Therapy
A Phase 4 study testing Pravastatin, Carvedilol, Perindopril and Biventricular assist device (Thoratec paracorporeal assist device) in people with Heart Failure, run by University Hospital, Strasbourg, France at 2 sites in France.
Trial summary
Cardiac function may improve in patients with end-stage heart failure who receive long-term support with ventricular assist devices (VAD). Reverse left ventricular remodeling may be sufficient in some cases to allow explantation of the VAD. However, some questions continue to await definitive answers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Pravastatin, Carvedilol, Perindopril and Biventricular assist device (Thoratec paracorporeal assist device)
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 2 sitesFrance
- Study dates
- Apr 2007to not given
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with end-stage heart failure refractory to medical therapy and who fulfill criteria for VAD implantation as a bridge to heart transplantation
- Age > 18
Who cannot join
- Myocarditis
Trial locations and contacts
2 sites in 1 country.
France2 sites
Service de Chirurgie Cardiovasculaire - Hôpital Civil
Strasbourg, 67091
Service de Physiologie Clinique - Hôpital Civil
Strasbourg, 67091
About this study
Official title: Effects of Combined Ventricular Unloading and Pharmacological Therapy on Left Ventricular Metabolic Dysfunction in Heart Failure
Cardiac function may improve in patients with end-stage heart failure who receive long-term support with ventricular assist devices (VAD). Reverse left ventricular remodeling may be sufficient in some cases to allow explantation of the VAD. However, some questions continue to await definitive answers. This study is designed to assess the myocardial recovery under VAD support with optimal pharmacological therapy (high doses [group I] of statins, beta-blockers, angiotensin-converting enzyme inhibitors versus standard doses [group II]).
The study is a randomized, single-blind trial performed at the Department of Cardiac Surgery, University of Strasbourg, France. Twenty patients with end-stage heart failure who will be supported by VAD (Thoratec paracorporeal device) as a bridge to heart transplantation will be included. Reverse left ventricular remodeling and myocardial function will be studied by: echocardiography, respiratory mitochondrial function, exercise testing, cardiac hormonal function, and inflammatory response. Myocardial biopsies will be obtained at the time of VAD implantation and heart transplantation. The follow-up will be performed every 4 weeks during the VAD support period. The hypothesis of this trial is that reverse left ventricular remodeling and myocardial function will improve under optimal medical therapy especially by a high dose statin.
Read the detailed description
Evaluation of Myocardial Improvement (Reverse Left Ventricular Remodeling, Mitochondrial Respiratory Function) in Patients Supported by Ventricular Assist Device Under Optimal Pharmacological Therapy
- Conditions
- Heart Failure
- Being tested
- Pravastatin, Carvedilol, Perindopril, Biventricular assist device (Thoratec paracorporeal assist device)
- Keywords
- End-stage heart failure, heart failure;, ventricular assist device;, statin;, heart transplantation;, myocardial function;, mitochondrial respiratory function;
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pravastatin, Carvedilol, PerindoprilDrug
Biventricular assist device (Thoratec paracorporeal assist device)Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Mitochondrial function
Measured: at implantation and explantation of VAD
Secondary outcomes (5)
Inflammation: IL-6; IL-8; IL-10, IL-18, TNF-α
Exercise testing : stress echocardiography, peak oxygen consumption
Hormonal cardiac function: ANP, BNP
Ventricular remodelling: echocardiography
All those parameters will be measured in the post-operative course and every 4 weeks during all the VAD support period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2006 (estimated)
- Study startApr 2007
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.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Collaborators
- Service de Chirurgie Cardiaque, Institut de Physiologie, Strasbourg, France, Institut National de la Santé Et de la Recherche Médicale, France
- Investigators
- Bernard Geny, MD, Study director, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00402376
- Sponsor's protocol ID
- 3212
- Status last verified
- Aug 2011
- First submitted
- 20 Nov 2006
- Last updated
- 30 Aug 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combined Ventricular Unloading and Pharmacological Therapy on Left Ventricular Metabolic Dysfunction in Heart Failure
- ClinicalTrials.gov ID
- NCT00402376
- Acronym / sponsor ID
- 3212
- Conditions
- Heart Failure
- Keywords
- End-stage heart failure, heart failure;, ventricular assist device;, statin;, heart transplantation;, myocardial function;, mitochondrial respiratory function;
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Collaborators
- Service de Chirurgie Cardiaque, Institut de Physiologie, Strasbourg, France, Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Apr 2007
- First posted
- 22 Nov 2006 (estimated)
- 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.
Cardiac function may improve in patients with end-stage heart failure who receive long-term support with ventricular assist devices (VAD). Reverse left ventricular remodeling may be sufficient in some cases to allow explantation of the VAD. However, some questions continue to await definitive answers. This study is designed to assess the myocardial recovery under VAD support with optimal pharmacological therapy (high doses [group I] of statins, beta-blockers, angiotensin-converting enzyme inhibitors versus standard doses [group II]).
The study is a randomized, single-blind trial performed at the Department of Cardiac Surgery, University of Strasbourg, France. Twenty patients with end-stage heart failure who will be supported by VAD (Thoratec paracorporeal device) as a bridge to heart transplantation will be included. Reverse left ventricular remodeling and myocardial function will be studied by: echocardiography, respiratory mitochondrial function, exercise testing, cardiac hormonal function, and inflammatory response. Myocardial biopsies will be obtained at the time of VAD implantation and heart transplantation. The follow-up will be performed every 4 weeks during the VAD support period. The hypothesis of this trial is that reverse left ventricular remodeling and myocardial function will improve under optimal medical therapy especially by a high dose statin.
Detailed description
Evaluation of Myocardial Improvement (Reverse Left Ventricular Remodeling, Mitochondrial Respiratory Function) in Patients Supported by Ventricular Assist Device Under Optimal Pharmacological Therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with end-stage heart failure refractory to medical therapy and who fulfill criteria for VAD implantation as a bridge to heart transplantation
- Age > 18
Key exclusion criteria (1 listed)
- Myocarditis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pravastatin, Carvedilol, Perindopril | Drug | – |
| Biventricular assist device (Thoratec paracorporeal assist device) | Device | – |
Primary outcome
Mitochondrial function
Time frame: at implantation and explantation of VAD
5 secondary outcomes
Inflammation: IL-6; IL-8; IL-10, IL-18, TNF-α
Exercise testing : stress echocardiography, peak oxygen consumption
Hormonal cardiac function: ANP, BNP
Ventricular remodelling: echocardiography
All those parameters will be measured in the post-operative course and every 4 weeks during all the VAD support period.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2011.
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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.
Bernard Geny, MD study director
Hôpitaux Universitaires de Strasbourg
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pravastatin, Carvedilol, Perindopril and Biventricular assist device (Thoratec paracorporeal assist device) in people with Heart Failure, run by University Hospital, Strasbourg, France at 2 sites in France.
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 2 inclusion and 1 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: stopped early, as of the sponsor's last update on 30 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Mitochondrial function (time frame: at implantation and explantation of VAD). 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 30 Aug 2011.