Heart FailureVP2HFNCT02732977
Mathematical Models Derived Indices for the Selection and Planning of a Specific Optimal Treatment to the Patient in Heart Failure
A study testing expert system development in people with Heart Failure, run by University Hospital, Caen.
Trial summary
Heart failure is a growing throughout pathology in Europe. It is a public health issue and an economic issue. The management to be effective needs to be early but specific. Generic treatment (medication, rehabilitation, hygienic dietary measures) known for over 15 years and has demonstrated its effectiveness, come… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- expert system development
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Nov 2017
- 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
- Have given informed consent for participation in the study.
- Male or female, aged 18 years
- Heart failure stage II -IV NYHA .
- Be awaiting a response to cardiac resynchronization therapy (CRT ) or replacement / repair of the mitral valve (MVR / r )
- Affiliated to social security scheme
- Francophone
Who cannot join
- Age <18 years
- Major Adult guardianship
- Pregnancy , lactation, or desire to start a pregnancy during the study period ( for women)
- Contraindications to MRI
- Continuous Treatment or continuous infusion with an inotropic agent for heart failure.
- Recent myocardial infarction ( <1 month) requiring revascularization
Show all 9Show fewer
- unbalanced severe hypertension ( BP> 160/110 mmHg)
- Significant hepatic impairment
- Any other significant disease or condition, which in the opinion of the investigator , may create a risk for the participant because of its participation in the study , or affect the results of the study, or to affect the patient's ability to participate in the study .
About this study
Heart failure is a growing throughout pathology in Europe. It is a public health issue and an economic issue. The management to be effective needs to be early but specific. Generic treatment (medication, rehabilitation, hygienic dietary measures) known for over 15 years and has demonstrated its effectiveness, come s'ajouter solutions specific, technically complex and expensive to implement. Because of the potential risk to the patient and their cost to the company, these new techniques need to be adapted to each case. The passage of a generic simple treatment for everyone in the single treatment tailored to each patient requires decision support tools for the clinician. These tools or decision trees are developed using mathematical and statistical models fed by all patient data (imaging, biology physiology ...) before and after implementation of treatment. Predictive response models of a treatment applied to a particular pathology can thus be generated.
It is this type of models applied in systolic heart failure complicated by mitral regurgitation and / or cardiac synchronization that will be generated in this project from 150 patients included in 3 European clinical studies (London, Brussels, Caen). In Caen we will include 30 patients in this single-center study
Read the detailed description
Heart failure (HF) is a clinical problem increasingly common throughout Europe, partly because of the aging population and increasing numbers of patients now survive after myocardial infarction [1, 2] . The IC is a progressive disease and when patients require hospitalization, long-term prognosis is poor [3]. The treatment of IC is focused on improving the work of the failing heart via the use of specific drugs, if necessary by cardiovascular interventions correcting structural lesions (mitral regurgitation) or correcting a disorganized contraction (therapy resynchronization). However, the IC is a disease complex with multiple factors pathophysiological interdependent making difficult treatment choices optimal or of a combination therapeutic optimal.
The technologies HPV predictive, such as tools for processing data, statistical models and simulations biophysical that incorporate these factors pathophysiological have tremendous potential to help improve our understanding of the response to treatment in the context of the IC. In particular, they have the potential to improve the selection of patients for cardiovascular interventions such as cardiac resynchronization therapy and / or that an intervention on the mitral valve [4].
Projects recent - European (HPV or Human physiological virtual) and national - have developed a large number of these technologies, but n'ont not been fully released into the environment clinic to help care for patients IC.
The objective of VP2HF project is to develop and validate in clinical settings computer modeling platform to integrate non-invasive clinical and imaging evidence acquired in patients with heart failure ( IC) for two reasons:
- Identify for each patient, the likely response to different therapeutic interventions with all clinical data processed by a decision support system.
- Optimize responses or interventions selected for each patient to maximize treatment response.
This is a pilot study to generate complete data sets used to parameterize the model calculations. All patients will have an accurate imaging assessment and a detailed assessment of bio-signals at times (time points) accurate (as shown above) with variations depending on the sustained cardiovascular procedure described below .
Preoperatively
- Evaluation of symptoms with the Minnesota Quality of Life Questionnaire in patients with heart failure (MLHFQ)
- 6 minute walk test
- cardiopulmonary stress test (CPET) to assess VO2 max
- Reference initials Blood tests (CBC, urea and electrolytes, NT-proBNP)
- 2D and 3D cardiac echocardiography
- Cardiac MRI including myocardial tattoo 3D sequences (tagging 3D) and 4D sequences for blood circulation
- Non-invasive measurement of central blood pressure
Peri-interference Whatever the treatment envisaged by the surgical team in charge of processing (resynchronization, mitral clip, mitral valve repair or mitral valve replacement) operative techniques and monitoring procedures will be those normally used by operators.
Cardiac resynchronization therapy (CRT) can be considered that 70% of patients in our cohort eligible for a CRT are also eligible for this project. Invasive measurement of left ventricular pressure with and without stimulation may also be acquired to study the acute hemodynamic effects of CRT and to make comparisons with the extent of NBP in order to test and validate the noninvasive pressure estimates and mechanical modeling tools.
Repair and replacement of the mitral valve: It is expected that 30% of our cohort of patients have significant mitral regurgitation requiring intervention, mainly to repair the mitral valve and the occasional replacement of the mitral valve when the repair is unsuccessful. In some of these patients, the repair will be carried out by trans-catheter track and they will hemodynamic measurements in the aorta, the left ventricle and the left atrium before and after the repair of the mitral valve that will be used for the purposes of test and validate non-invasive estimates of pressure and mechanical modeling tools.
Immediately after surgery All patients will again echocardiography, non-invasive measurement of central blood pressure.
Followed at 6 months We will again perform , 6 months after surgery , complete postoperative evaluation unless cardiac MRI in patients with a CRT ( because this review is against - indicated ) .
in addition to standard care pathway exams non-invasive measurement of central blood pressure The non -invasive blood pressure management Centron Diagnostics uses a humeral standard oscillatory cuff estimate both the PA peripheral and central aortic pressure. For the patient, this is an experiment similar to that of an automatic blood pressure recording . All patients benefit from this measure .
Exams IRM3T to Cycéron (M0 and M6)
- Conditions
- Heart Failure
- Being tested
- expert system development
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
expert system developmentOther
Also called System that can predict response to a personalized treatment
data collection (imaging, biology physiology ... ) of patients with systolic heart failure complicated by mitral regurgitation and / or cardiac synchronization before and after implementation of the recommended standard treatments and modeling using mathematical and statistical models fed all data .
| Study group | Role | What they receive |
|---|---|---|
| expert system | Other | System for predicting patients heart failure, that can predict response to a personalized treatment from the analysis of a set of data (images, physiological data , treatment outcomes ) . Receives: Other: expert system development |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction from the model computer remodeling reverse
Prediction from the model computer remodeling reverse as defined by reduced LVESV 15 % (on ultrasound or MRI) 6 months after the intervention (CRT or VCR / r ) .
Measured: 6 month after intervention
Secondary outcomes (5)
MLHFQ Questionnaire
Prediction based computer model of the response to intervention as defined by an improvement 6 months after intervention
Measured: 6 month after intervention
6 minute walk test ( 6MWT )
Prediction based computer model of the response to intervention as defined by an improvement 6 months after intervention
Measured: 6 month after intervention
VO2 max
Prediction based computer model of the response to intervention as defined by an improvement 6 months after intervention
Measured: 6 month after intervention
NT-proBNP
Prediction based computer model of the response to intervention as defined by an improvement 6 months after intervention
Measured: 6 month after intervention
non-invasive measurement of central blood pressure
Prediction based computer model of the response to intervention as defined by an improvement 6 months after intervention
Measured: 6 month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2016 (estimated)
- Study startNov 2014
- Primary completionNov 2016 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric SE Saloux, MD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02732977
- Sponsor's protocol ID
- 2014-A00693-44
- Acronym
- VP2HF
- Status last verified
- Apr 2016
- First submitted
- 5 Apr 2016
- Last updated
- 11 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mathematical Models Derived Indices for the Selection and Planning of a Specific Optimal Treatment to the Patient in Heart Failure
- ClinicalTrials.gov ID
- NCT02732977
- Acronym / sponsor ID
- VP2HF / 2014-A00693-44
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 11 Apr 2016 (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 growing throughout pathology in Europe. It is a public health issue and an economic issue. The management to be effective needs to be early but specific. Generic treatment (medication, rehabilitation, hygienic dietary measures) known for over 15 years and has demonstrated its effectiveness, come s'ajouter solutions specific, technically complex and expensive to implement. Because of the potential risk to the patient and their cost to the company, these new techniques need to be adapted to each case. The passage of a generic simple treatment for everyone in the single treatment tailored to each patient requires decision support tools for the clinician. These tools or decision trees are developed using mathematical and statistical models fed by all patient data (imaging, biology physiology ...) before and after implementation of treatment. Predictive response models of a treatment applied to a particular pathology can thus be generated.
It is this type of models applied in systolic heart failure complicated by mitral regurgitation and / or cardiac synchronization that will be generated in this project from 150 patients included in 3 European clinical studies (London, Brussels, Caen). In Caen we will include 30 patients in this single-center study
Detailed description
Heart failure (HF) is a clinical problem increasingly common throughout Europe, partly because of the aging population and increasing numbers of patients now survive after myocardial infarction [1, 2] . The IC is a progressive disease and when patients require hospitalization, long-term prognosis is poor [3]. The treatment of IC is focused on improving the work of the failing heart via the use of specific drugs, if necessary by cardiovascular interventions correcting structural lesions (mitral regurgitation) or correcting a disorganized contraction (therapy resynchronization). However, the IC is a disease complex with multiple factors pathophysiological interdependent making difficult treatment choices optimal or of a combination therapeutic optimal.
The technologies HPV predictive, such as tools for processing data, statistical models and simulations biophysical that incorporate these factors pathophysiological have tremendous potential to help improve our understanding of the response to treatment in the context of the IC. In particular, they have the potential to improve the selection of patients for cardiovascular interventions such as cardiac resynchronization therapy and / or that an intervention on the mitral valve [4].
Projects recent - European (HPV or Human physiological virtual) and national - have developed a large number of these technologies, but n'ont not been fully released into the environment clinic to help care for patients IC.
The objective of VP2HF project is to develop and validate in clinical settings computer modeling platform to integrate non-invasive clinical and imaging evidence acquired in patients with heart failure ( IC) for two reasons:
- Identify for each patient, the likely response to different therapeutic interventions with all clinical data processed by a decision support system.
- Optimize responses or interventions selected for each patient to maximize treatment response.
This is a pilot study to generate complete data sets used to parameterize the model calculations. All patients will have an accurate imaging assessment and a detailed assessment of bio-signals at times (time points) accurate (as shown above) with variations depending on the sustained cardiovascular procedure described below .
Preoperatively
- Evaluation of symptoms with the Minnesota Quality of Life Questionnaire in patients with heart failure (MLHFQ)
- 6 minute walk test
- cardiopulmonary stress test (CPET) to assess VO2 max
- Reference initials Blood tests (CBC, urea and electrolytes, NT-proBNP)
- 2D and 3D cardiac echocardiography
- Cardiac MRI including myocardial tattoo 3D sequences (tagging 3D) and 4D sequences for blood circulation
- Non-invasive measurement of central blood pressure
Peri-interference Whatever the treatment envisaged by the surgical team in charge of processing (resynchronization, mitral clip, mitral valve repair or mitral valve replacement) operative techniques and monitoring procedures will be those normally used by operators.
Cardiac resynchronization therapy (CRT) can be considered that 70% of patients in our cohort eligible for a CRT are also eligible for this project. Invasive measurement of left ventricular pressure with and without stimulation may also be acquired to study the acute hemodynamic effects of CRT and to make comparisons with the extent of NBP in order to test and validate the noninvasive pressure estimates and mechanical modeling tools.
Repair and replacement of the mitral valve: It is expected that 30% of our cohort of patients have significant mitral regurgitation requiring intervention, mainly to repair the mitral valve and the occasional replacement of the mitral valve when the repair is unsuccessful. In some of these patients, the repair will be carried out by trans-catheter track and they will hemodynamic measurements in the aorta, the left ventricle and the left atrium before and after the repair of the mitral valve that will be used for the purposes of test and validate non-invasive estimates of pressure and mechanical modeling tools.
Immediately after surgery All patients will again echocardiography, non-invasive measurement of central blood pressure.
Followed at 6 months We will again perform , 6 months after surgery , complete postoperative evaluation unless cardiac MRI in patients with a CRT ( because this review is against - indicated ) .
in addition to standard care pathway exams non-invasive measurement of central blood pressure The non -invasive blood pressure management Centron Diagnostics uses a humeral standard oscillatory cuff estimate both the PA peripheral and central aortic pressure. For the patient, this is an experiment similar to that of an automatic blood pressure recording . All patients benefit from this measure .
Exams IRM3T to Cycéron (M0 and M6)
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| expert system | Other | Other: expert system developmentSystem for predicting patients heart failure, that can predict response to a personalized treatment from the analysis of a set of data (images, physiological data , treatment outcomes ) . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have given informed consent for participation in the study.
- Male or female, aged 18 years
- Heart failure stage II -IV NYHA .
- Be awaiting a response to cardiac resynchronization therapy (CRT ) or replacement / repair of the mitral valve (MVR / r )
- Affiliated to social security scheme
Key exclusion criteria (9 listed)
- Age <18 years
- Major Adult guardianship
- Pregnancy , lactation, or desire to start a pregnancy during the study period ( for women)
- Contraindications to MRI
- Continuous Treatment or continuous infusion with an inotropic agent for heart failure.
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 |
|---|---|---|
| expert system developmentAlso: System that can predict response to a personalized treatmentdata collection (imaging, biology physiology ... ) of patients with systolic heart failure complicated by mitral regurgitation and / or cardiac synchronization before and after implementation of the recommended standard treatments and modeling using mathematical and statistical models fed all data . | Other | expert system |
Primary outcome
Prediction from the model computer remodeling reverse
Time frame: 6 month after intervention
Prediction from the model computer remodeling reverse as defined by reduced LVESV 15 % (on ultrasound or MRI) 6 months after the intervention (CRT or VCR / r ) .
5 secondary outcomes
MLHFQ Questionnaire
Time frame: 6 month after intervention
6 minute walk test ( 6MWT )
Time frame: 6 month after intervention
VO2 max
Time frame: 6 month after intervention
NT-proBNP
Time frame: 6 month after intervention
non-invasive measurement of central blood pressure
Time frame: 6 month after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2016.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
Recruiting
Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System
Chronic Heart Failure, CKD Stage 3
Not yet recruiting
SWitching to Appropriate Prescription in Cardiovascular-Kidney-Metabolic Syndrome
Cardiovascular-kidney-metabolic Syndrome, Diabete Type 2
Not yet recruiting
Notification Of High-Risk Veterans for Access to Heart Failure Prevention
Heart Failure
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Recruiting
Achieving Optimal Medical Therapy Through Percutaneous Treatment of Secondary Mitral Regurgitation to Improve Outcome in Patients With HFrEF
Mitral Regurgitation Functional, Heart Failure With Reduced Ejection Fraction (HFrEF)
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.
Eric SE Saloux, MD principal investigator
University Hospital, Caen
Questions about this trial
What is this clinical trial studying?
A study testing expert system development in people with Heart Failure, run by University Hospital, Caen.
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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 11 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Prediction from the model computer remodeling reverse (time frame: 6 month after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2016.