An interventional study of adding 2 cardiopulmonary exercise testings : peak oxygen consumption (VO2 max) and stress echocardiography in Left Ventricular Assist Devices Patients, sponsored by Rennes University Hospital. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-01.
Sponsored by Rennes University Hospital · Not applicable and Interventional
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.
Rennes University Hospital is the lead sponsor of 440 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Other: adding 2 cardiopulmonary exercise testings : peak oxygen consumption (VO2 max) and stress echocardiography
Also known as: - resting echocardiography, - routine bloods tests, - 1 stress echocardiography on a supine bicycle over the follow, - 1 peak oxygen consumption recorded while breathing through a gas analyser
assessment of right chambers dimensions for the evaluation of right ventricular function
Time frame: 12 months
assessment of RV strain for the evaluation of right ventricular function
Time frame: 12 months
assessment of RV shortening fraction for the evaluation of right ventricular function
Time frame: 12 months
assessment of TAPSE for the Evaluation of right ventricular function
Time frame: 12 months
assessment of RV fractional Area change for the evaluation of right ventricular function
Time frame: 12 months
assessment of Tricuspid annulus tissue doppler imaging for the evaluation of right ventricular function
Time frame: 12 months
Tricuspid regurgitation analysis for the evaluation of right ventricular function
Time frame: 12 months
pulmonary pressures analysis for the evaluation of right ventricular function
Time frame: 12 months
Assessment of RV strain rate for the evaluation of right ventricular function
Time frame: 12 months
peak oxygen consumption (VO2 max) as a functional evaluation of VO2 max on exercise
Time frame: 12 months
quality of life scores as an assessment of quality of life
Time frame: 12 months
BNP levels as an assessment of BNP levels
Time frame: 12 months
Blood pressure monitoring as an assessment of blood pressure
Time frame: 12 months
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Rennes University Hospital