Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 35RC13_8808_REVADE | Other Identifier | Rennes University Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Heart failure is a public health problem, responsible for 150.000 admissions, 32.000 deaths, 1% of public health expenditure each year in France. Heart transplantation remains the standard of care in patients for which medical therapy is not sufficient. But heart transplantation is a limited resource, as a result of donor shortages. It is therefore possible to consider mechanical circulatory support for patients awaiting heart transplantation or for those who are not suitable for transplantation. Left Ventricular Assist Devices (LVAD) are portable pumps which help the left side of the heart to provide appropriate "cardiac" output. in this type of device, right heart is not assisted and must work on its own, LVADs are thus implanted in patients whose right ventricular function is normal.
The aim of the REVADE study is to assess right ventricular echocardiographic parameters in this population, especially on physical exercise, for a better understanding of right ventricular adaptation to this long-term modified pressure pattern.
This is a non-randomized, single-center, prospective investigation on exercise capacities of LVAD recipients.
LVAD patients already have in our unit the following regular monitoring:
The REVADE pilot study consists in adding 2 cardiopulmonary exercise testings to their existing follow-up : peak oxygen consumption (VO2 max) and stress echocardiography.
We plan to do 1 stress echocardiography on a supine bicycle over the follow-up, and 1 peak oxygen consumption recorded while breathing through a gas analyzer.
Total study length of time will be 1 year. Expected number of enrolled patients is 18.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LVAD patients | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adding 2 cardiopulmonary exercise testings : peak oxygen consumption (VO2 max) and stress echocardiography | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| assessment of right chambers dimensions for the evaluation of right ventricular function | 12 months | |
| assessment of RV strain for the evaluation of right ventricular function | 12 months | |
| assessment of RV shortening fraction for the evaluation of right ventricular function | 12 months | |
| assessment of TAPSE for the Evaluation of right ventricular function | 12 months | |
| assessment of RV fractional Area change for the evaluation of right ventricular function | 12 months | |
| assessment of Tricuspid annulus tissue doppler imaging for the evaluation of right ventricular function | 12 months | |
| Tricuspid regurgitation analysis for the evaluation of right ventricular function | 12 months | |
| pulmonary pressures analysis for the evaluation of right ventricular function | 12 months | |
| Assessment of RV strain rate for the evaluation of right ventricular function | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| peak oxygen consumption (VO2 max) as a functional evaluation of VO2 max on exercise | 12 months | |
| quality of life scores as an assessment of quality of life | 12 months | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Erwan DONAL | Rennes University Hospital | Principal Investigator |
| ERWAN FLECHER | Rennes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de cardiologie - Rennes university hospital | Rennes | 35033 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26705752 | Derived | Aymami M, Donal E, Guihaire J, Le Helloco A, Federspiel M, Galli E, Carre F, Lelong B, Chabanne C, Corbineau H, Leguerrier A, Verhoye JP, Flecher E. Rest and Exercise Adaptation of the Right Ventricular Function in Long-Term Left Ventricular Assist Device Patients: A Prospective, Pilot Study. J Card Fail. 2016 Mar;22(3):240-1. doi: 10.1016/j.cardfail.2015.12.009. Epub 2015 Dec 17. No abstract available. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| BNP levels as an assessment of BNP levels |
| 12 months |
| Blood pressure monitoring as an assessment of blood pressure | 12 months |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
Not provided
Not provided