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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Rennes University Hospital
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT02067455
First received: February 11, 2014
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Left Ventricular Assist Devices Patients
Other: adding 2 cardiopulmonary exercise testings : peak oxygen consumption (VO2 max) and stress echocardiography

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: This is a Non-randomized, Single-center, Prospective Investigation on Exercise Capacities of Left Ventricular Assist Devices Recipients

Resource links provided by NLM:


Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • assessment of right chambers dimensions for the evaluation of right ventricular function [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • assessment of RV strain for the evaluation of right ventricular function [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • assessment of RV shortening fraction for the evaluation of right ventricular function [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • assessment of TAPSE for the Evaluation of right ventricular function [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • assessment of RV fractional Area change for the evaluation of right ventricular function [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • assessment of Tricuspid annulus tissue doppler imaging for the evaluation of right ventricular function [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Tricuspid regurgitation analysis for the evaluation of right ventricular function [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • pulmonary pressures analysis for the evaluation of right ventricular function [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Assessment of RV strain rate for the evaluation of right ventricular function [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • peak oxygen consumption (VO2 max) as a functional evaluation of VO2 max on exercise [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • quality of life scores as an assessment of quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • BNP levels as an assessment of BNP levels [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Blood pressure monitoring as an assessment of blood pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: February 2014
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02067455

Contacts
Contact: Erwan DONAL 33 2 28 71 74 erwan.donal@chu-rennes.fr
Contact: Erwan FLECHER 33 2 28 24 97 erwan.flecher@chu-rennes.fr

Locations
France
Service de cardiologie - Rennes university hospital Recruiting
Rennes, France, 35033
Sponsors and Collaborators
Rennes University Hospital
Investigators
Principal Investigator: Erwan DONAL Rennes University Hospital
Principal Investigator: ERWAN FLECHER Rennes University Hospital
  More Information

No publications provided

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT02067455     History of Changes
Other Study ID Numbers: 2013-A01798-37, 35RC13_8808_REVADE
Study First Received: February 11, 2014
Last Updated: May 12, 2014
Health Authority: France: The Commission nationale de l’informatique et des libertés

Keywords provided by Rennes University Hospital:
Right ventricular function
echocardiography
left ventricular assist device
exercise

ClinicalTrials.gov processed this record on August 19, 2014