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

March 31, 2016 updated by: Rennes University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rennes, France, 35033
        • Service de cardiologie - Rennes university hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: LVAD patients
Other: adding 2 cardiopulmonary exercise testings : peak oxygen consumption (VO2 max) and stress echocardiography
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
assessment of right chambers dimensions for the evaluation of right ventricular function
Time Frame: 12 months
12 months
assessment of RV strain for the evaluation of right ventricular function
Time Frame: 12 months
12 months
assessment of RV shortening fraction for the evaluation of right ventricular function
Time Frame: 12 months
12 months
assessment of TAPSE for the Evaluation of right ventricular function
Time Frame: 12 months
12 months
assessment of RV fractional Area change for the evaluation of right ventricular function
Time Frame: 12 months
12 months
assessment of Tricuspid annulus tissue doppler imaging for the evaluation of right ventricular function
Time Frame: 12 months
12 months
Tricuspid regurgitation analysis for the evaluation of right ventricular function
Time Frame: 12 months
12 months
pulmonary pressures analysis for the evaluation of right ventricular function
Time Frame: 12 months
12 months
Assessment of RV strain rate for the evaluation of right ventricular function
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
peak oxygen consumption (VO2 max) as a functional evaluation of VO2 max on exercise
Time Frame: 12 months
12 months
quality of life scores as an assessment of quality of life
Time Frame: 12 months
12 months
BNP levels as an assessment of BNP levels
Time Frame: 12 months
12 months
Blood pressure monitoring as an assessment of blood pressure
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Investigators

  • Principal Investigator: Erwan Donal, Rennes University Hospital
  • Principal Investigator: ERWAN FLECHER, Rennes University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

February 11, 2014

First Submitted That Met QC Criteria

February 17, 2014

First Posted (Estimate)

February 20, 2014

Study Record Updates

Last Update Posted (Estimate)

April 1, 2016

Last Update Submitted That Met QC Criteria

March 31, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2013-A01798-37
  • 35RC13_8808_REVADE (Other Identifier: Rennes University Hospital)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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