Left Ventricular Assist Devices Patients
Conditions
Keywords
Right ventricular function, echocardiography, left ventricular assist device, exercise
Brief summary
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.
Detailed description
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: * clinical examination * Minnesota Living with Heart Failure Questionnaire (MLHFQ) * SF-36 Health Survey * Six-Minute Walk Test * resting echocardiography * routine blood tests. 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.
Interventions
OTHERadding 2 cardiopulmonary exercise testings : peak oxygen consumption (VO2 max) and stress echocardiography
Sponsors
Rennes University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* left ventricular assist device (LVAD) recipients * age \> 18 years * able to give consent
Exclusion criteria
* adults legally protected (under judicial protection, guardianship, or supervision) or deprived of liberty * patients unable to provide sufficient effort for exercise testing * poor echogenicity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of RV strain rate 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 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 |
Secondary
| Measure | Time frame |
|---|---|
| quality of life scores as an assessment of quality of life | 12 months |
| BNP levels as an assessment of BNP levels | 12 months |
| Blood pressure monitoring as an assessment of blood pressure | 12 months |
| peak oxygen consumption (VO2 max) as a functional evaluation of VO2 max on exercise | 12 months |
Countries
France
Outcome results
None listed