Left Ventricular Assist Devices PatientsREVADENCT02067455
REVADE : Right Ventricular Function and Exercise in Left Ventricular Assist Device Patients : Echocardiographic Study
A study testing adding 2 cardiopulmonary exercise testings : peak oxygen consumption (VO2 max) and stress echocardiography in people with Left Ventricular Assist Devices Patients, run by Rennes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Ventricular Assist Devices Patients
- What is being tested?
- adding 2 cardiopulmonary exercise testings : peak oxygen consumption (VO2 max) and stress echocardiography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- left ventricular assist device (LVAD) recipients
- age > 18 years
- able to give consent
Who cannot join
- adults legally protected (under judicial protection, guardianship, or supervision) or deprived of liberty
- patients unable to provide sufficient effort for exercise testing
- poor echogenicity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Left Ventricular Assist Devices Patients
- Being tested
- adding 2 cardiopulmonary exercise testings : peak oxygen consumption (VO2 max) and stress echocardiography
- Keywords
- Right ventricular function, echocardiography, left ventricular assist device, exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adding 2 cardiopulmonary exercise testings : peak oxygen consumption (VO2 max) and stress echocardiographyOther
Also called - 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
| Study group | Role | What they receive |
|---|---|---|
| LVAD patients | Other | Not described Receives: Other: adding 2 cardiopulmonary exercise testings : peak oxygen consumption (VO2 max) and stress echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of right chambers dimensions for the evaluation of right ventricular function
Measured: 12 months
assessment of RV strain for the evaluation of right ventricular function
Measured: 12 months
assessment of RV shortening fraction for the evaluation of right ventricular function
Measured: 12 months
assessment of TAPSE for the Evaluation of right ventricular function
Measured: 12 months
assessment of RV fractional Area change for the evaluation of right ventricular function
Measured: 12 months
assessment of Tricuspid annulus tissue doppler imaging for the evaluation of right ventricular function
Measured: 12 months
Tricuspid regurgitation analysis for the evaluation of right ventricular function
Measured: 12 months
pulmonary pressures analysis for the evaluation of right ventricular function
Measured: 12 months
Assessment of RV strain rate for the evaluation of right ventricular function
Measured: 12 months
Secondary outcomes (4)
peak oxygen consumption (VO2 max) as a functional evaluation of VO2 max on exercise
Measured: 12 months
quality of life scores as an assessment of quality of life
Measured: 12 months
BNP levels as an assessment of BNP levels
Measured: 12 months
Blood pressure monitoring as an assessment of blood pressure
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Left Ventricular Assist Devices PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erwan DONAL, Principal investigator, Rennes University HospitalERWAN FLECHER, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02067455
- Sponsor's protocol ID
- 2013-A01798-37
- Other IDs
- 35RC13_8808_REVADE
- Acronym
- REVADE
- Status last verified
- Mar 2016
- First submitted
- 11 Feb 2014
- Last updated
- 1 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Aymami M, Donal E, Guihaire J, Le Helloco A, Federspiel M, Galli E, Carre F, Lelong B, Chabanne C, Corbineau H, Leguerrier A, Verhoye JP, Flecher E. Rest and Exercise Adaptation of the Right Ventricular Function in Long-Term Left Ventricular Assist Device Patients: A Prospective, Pilot Study. J Card Fail. 2016 Mar;22(3):240-1. doi: 10.1016/j.cardfail.2015.12.009. Epub 2015 Dec 17. No abstract available.
PubMed 26705752
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- This is a Non-randomized, Single-center, Prospective Investigation on Exercise Capacities of Left Ventricular Assist Devices Recipients
- ClinicalTrials.gov ID
- NCT02067455
- Acronym / sponsor ID
- REVADE / 2013-A01798-37
- Conditions
- Left Ventricular Assist Devices Patients
- Keywords
- Right ventricular function, echocardiography, left ventricular assist device, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 20 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LVAD patients | Other | Other: adding 2 cardiopulmonary exercise testings : peak oxygen consumption (VO2 max) and stress echocardiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- left ventricular assist device (LVAD) recipients
- age > 18 years
- able to give consent
Key exclusion criteria (3 listed)
- adults legally protected (under judicial protection, guardianship, or supervision) or deprived of liberty
- patients unable to provide sufficient effort for exercise testing
- poor echogenicity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adding 2 cardiopulmonary exercise testings : peak oxygen consumption (VO2 max) and stress echocardiographyAlso: - 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 | Other | LVAD patients |
Primary outcome
assessment of right chambers dimensions for the evaluation of right ventricular function
Time frame: 12 months
assessment of RV strain for the evaluation of right ventricular function
Time frame: 12 months
assessment of RV shortening fraction for the evaluation of right ventricular function
Time frame: 12 months
assessment of TAPSE for the Evaluation of right ventricular function
Time frame: 12 months
assessment of RV fractional Area change for the evaluation of right ventricular function
Time frame: 12 months
assessment of Tricuspid annulus tissue doppler imaging for the evaluation of right ventricular function
Time frame: 12 months
Tricuspid regurgitation analysis for the evaluation of right ventricular function
Time frame: 12 months
pulmonary pressures analysis for the evaluation of right ventricular function
Time frame: 12 months
Assessment of RV strain rate for the evaluation of right ventricular function
Time frame: 12 months
4 secondary outcomes
peak oxygen consumption (VO2 max) as a functional evaluation of VO2 max on exercise
Time frame: 12 months
quality of life scores as an assessment of quality of life
Time frame: 12 months
BNP levels as an assessment of BNP levels
Time frame: 12 months
Blood pressure monitoring as an assessment of blood pressure
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2016.
- Derived from this study: PubMed 26705752Aymami M, Donal E, Guihaire J, Le Helloco A, Federspiel M, Galli E, Carre F, Lelong B, Chabanne C, Corbineau H, Leguerrier A, Verhoye JP, Flecher E. Rest and Exercise Adaptation of the Right Ventricular Function in Long-Term Left Ventricular Assist Device Patients: A Prospective, Pilot Study. J Card Fail. 2016 Mar;22(3):240-1. doi: 10.1016/j.cardfail.2015.12.009. Epub 2015 Dec 17. No abstract available.
Related trials for Left Ventricular Assist Devices Patients
Active, not recruiting
The JenaValve ALIGN-AR LVAD Registry
Aortic Regurgitation, Aortic Valve Insufficiency
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A First-in-Human Study to Evaluate the Safety and Efficacy of Left Ventricular Assist Device Combined With Exosome Therapy for Patients With Heart Failure（RESTORATION）
Heart Failure
Not yet recruitingPhase 3
SWITCH: Apixaban vs Vitamin K in HM3
LVAD (Left Ventricular Assist Device) Thrombosis, Heart Failure
Active, not recruiting
Assessment of Safety and Accuracy of the Microtech System in Patients Undergoing Left Ventricular Assist Device Implantation
Heart Failure
RecruitingObservational study
Assessing Changes in Myocardial Tissue and Blood in Patients With Advanced Heart Disease
Congestive Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erwan DONAL principal investigator
Rennes University Hospital
ERWAN FLECHER principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing adding 2 cardiopulmonary exercise testings : peak oxygen consumption (VO2 max) and stress echocardiography in people with Left Ventricular Assist Devices Patients, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of right chambers dimensions for the evaluation of right ventricular function (time frame: 12 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02067455, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2016.