NCT02067455

REVADE : Right Ventricular Function and Exercise in Left Ventricular Assist Device Patients : Echocardiographic Study

This is a Non-randomized, Single-center, Prospective Investigation on Exercise Capacities of Left Ventricular Assist Devices Recipients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Rennes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Left Ventricular Assist Devices Patients

Interventions

Type	Name	Description
OTHER	adding 2 cardiopulmonary exercise testings : peak oxygen consumption (VO2 max) and stress echocardiography

Timeline

• Start date: 2014-02-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2014-02-20
• Last updated: 2016-04-01

Locations

1 site across 1 country: France