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| Name | Class |
|---|---|
| Service de Chirurgie Cardiaque | UNKNOWN |
| Institut de Physiologie, Strasbourg, France | UNKNOWN |
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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.
Evaluation of Myocardial Improvement (Reverse Left Ventricular Remodeling, Mitochondrial Respiratory Function) in Patients Supported by Ventricular Assist Device Under Optimal Pharmacological Therapy
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pravastatin, Carvedilol, Perindopril | Drug | |||
| Biventricular assist device (Thoratec paracorporeal assist device) | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Mitochondrial function | at implantation and explantation of VAD |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammation: IL-6; IL-8; IL-10, IL-18, TNF-α | ||
| Exercise testing : stress echocardiography, peak oxygen consumption | ||
| Hormonal cardiac function: ANP, BNP |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernard Geny, MD | Hôpitaux Universitaires de Strasbourg | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Chirurgie Cardiovasculaire - Hôpital Civil | Strasbourg | 67091 | France | |||
| Service de Physiologie Clinique - Hôpital Civil |
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| Ventricular remodelling: echocardiography |
| All those parameters will be measured in the post-operative course and every 4 weeks during all the VAD support period. |
| Strasbourg |
| 67091 |
| France |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017035 | Pravastatin |
| D000077261 | Carvedilol |
| D020913 | Perindopril |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D020005 | Propanols |
| D000588 | Amines |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |
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