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NCT Number: NCT02067455

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

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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Key information

Conditions

Left Ventricular Assist Devices Patients Behavior Motor Activity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de cardiologie - Rennes university hospital

Rennes, 35033, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

Other names: - 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

Primary outcomes

  1. assessment of right chambers dimensions for the evaluation of right ventricular function

    Time frame: 12 months

  2. assessment of RV strain for the evaluation of right ventricular function

    Time frame: 12 months

  3. assessment of RV shortening fraction for the evaluation of right ventricular function

    Time frame: 12 months

  4. assessment of TAPSE for the Evaluation of right ventricular function

    Time frame: 12 months

  5. assessment of RV fractional Area change for the evaluation of right ventricular function

    Time frame: 12 months

  6. assessment of Tricuspid annulus tissue doppler imaging for the evaluation of right ventricular function

    Time frame: 12 months

  7. Tricuspid regurgitation analysis for the evaluation of right ventricular function

    Time frame: 12 months

  8. pulmonary pressures analysis for the evaluation of right ventricular function

    Time frame: 12 months

  9. Assessment of RV strain rate for the evaluation of right ventricular function

    Time frame: 12 months

Secondary outcomes

  1. peak oxygen consumption (VO2 max) as a functional evaluation of VO2 max on exercise

    Time frame: 12 months

  2. quality of life scores as an assessment of quality of life

    Time frame: 12 months

  3. BNP levels as an assessment of BNP levels

    Time frame: 12 months

  4. Blood pressure monitoring as an assessment of blood pressure

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

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

Acronym: REVADE

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 20, 2014
Registry last updated
Apr 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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