REVADE : Right Ventricular Function and Exercise in Left Ventricular Assist Device Patients : Echocardiographic Study
- Conditions
- Left Ventricular Assist Devices Patients
- Registration Number
- NCT02067455
- Lead Sponsor
- Rennes University Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- left ventricular assist device (LVAD) recipients
- age > 18 years
- able to give consent
- adults legally protected (under judicial protection, guardianship, or supervision) or deprived of liberty
- patients unable to provide sufficient effort for exercise testing
- poor echogenicity
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method assessment of right chambers dimensions for the evaluation of right ventricular function 12 months assessment of RV fractional Area change 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 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 Tricuspid regurgitation analysis for the evaluation of right ventricular function 12 months Assessment of RV strain rate 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
- Secondary Outcome Measures
Name Time Method peak oxygen consumption (VO2 max) as a functional evaluation of VO2 max on exercise 12 months BNP levels as an assessment of BNP levels 12 months Blood pressure monitoring as an assessment of blood pressure 12 months quality of life scores as an assessment of quality of life 12 months
Trial Locations
- Locations (1)
Service de cardiologie - Rennes university hospital
🇫🇷Rennes, France