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

• Sponsor: Rennes University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02067455
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1
• Duration (Months): 19
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Left Ventricular Assist Devices Patients	Other: adding 2 cardiopulmonary exercise testings : peak oxygen consumption (VO2 max) and stress echocardiography	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Official Title: This is a Non-randomized, Single-center, Prospective Investigation on Exercise Capacities of Left Ventricular Assist Devices Recipients
• Study Start Date: Feb 1, 2014
• Actual Primary Completion Date: Sep 1, 2015
• Actual Study Completion Date: Sep 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. assessment of right chambers dimensions for the evaluation of right ventricular function [12 months]

2. assessment of RV strain for the evaluation of right ventricular function [12 months]

3. assessment of RV shortening fraction for the evaluation of right ventricular function [12 months]

4. assessment of TAPSE for the Evaluation of right ventricular function [12 months]

5. assessment of RV fractional Area change for the evaluation of right ventricular function [12 months]

6. assessment of Tricuspid annulus tissue doppler imaging for the evaluation of right ventricular function [12 months]

7. Tricuspid regurgitation analysis for the evaluation of right ventricular function [12 months]

8. pulmonary pressures analysis for the evaluation of right ventricular function [12 months]

9. Assessment of RV strain rate for the evaluation of right ventricular function [12 months]

Secondary Outcome Measures

1. peak oxygen consumption (VO2 max) as a functional evaluation of VO2 max on exercise [12 months]

2. quality of life scores as an assessment of quality of life [12 months]

3. BNP levels as an assessment of BNP levels [12 months]

4. Blood pressure monitoring as an assessment of blood pressure [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Service de cardiologie - Rennes university hospital	Rennes		France	35033

Sponsors and Collaborators

• Rennes University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rennes University Hospital
• ClinicalTrials.gov Identifier: NCT02067455
• Other Study ID Numbers: 2013-A01798-37; 35RC13_8808_REVADE
• First Posted: Feb 20, 2014
• Last Update Posted: Apr 1, 2016
• Last Verified: Mar 1, 2016

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

Study Results

No Results Posted as of Apr 1, 2016