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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-09-30

Brief Summary

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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.

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Detailed Description

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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

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Left Ventricular Assist Devices Patients

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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LVAD patients

Group Type OTHER

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

Intervention Type OTHER

Interventions

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

Intervention Type OTHER

Other Intervention Names

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- 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

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No