Clinical trial NCT02067455: REVADE : Right Ventricular Function and Exercise in Left Ventricular Assist Device Patients : Echocardiographic Study
Official title: This is a Non-randomized, Single-center, Prospective Investigation on Exercise Capacities of Left Ventricular Assist Devices Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Left Ventricular Assist Devices Patients
Keywords: Right ventricular function
echocardiography
left ventricular assist device
exercise
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2014-02-20
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.

Eligibility criteria: 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

Primary outcomes:
measure: assessment of right chambers dimensions for the evaluation of right ventricular function
timeFrame: 12 months
measure: assessment of RV strain for the evaluation of right ventricular function
timeFrame: 12 months
measure: assessment of RV shortening fraction for the evaluation of right ventricular function
timeFrame: 12 months
measure: assessment of TAPSE for the Evaluation of right ventricular function
timeFrame: 12 months
measure: assessment of RV fractional Area change for the evaluation of right ventricular function
timeFrame: 12 months
measure: assessment of Tricuspid annulus tissue doppler imaging for the evaluation of right ventricular function
timeFrame: 12 months
measure: Tricuspid regurgitation analysis for the evaluation of right ventricular function
timeFrame: 12 months
measure: pulmonary pressures analysis for the evaluation of right ventricular function
timeFrame: 12 months
measure: Assessment of RV strain rate for the evaluation of right ventricular function
timeFrame: 12 months
Secondary outcomes:
measure: peak oxygen consumption (VO2 max) as a functional evaluation of VO2 max on exercise
timeFrame: 12 months
measure: quality of life scores as an assessment of quality of life
timeFrame: 12 months
measure: BNP levels as an assessment of BNP levels
timeFrame: 12 months
measure: Blood pressure monitoring as an assessment of blood pressure
timeFrame: 12 months
Other outcomes:
Locations:
city: Rennes
country: France
facility: Service de cardiologie - Rennes university hospital
Study officials:
affiliation: Rennes University Hospital
name: Erwan DONAL
role: PRINCIPAL_INVESTIGATOR
affiliation: Rennes University Hospital
name: ERWAN FLECHER
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.