Mathematical Models Derived Indices for the Selection and Planning of a Specific Optimal Treatment to the Patient in Heart Failure

NCT02732977 | Unknown

• 1 other identifier: 2014-A00693-44
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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 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

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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 ) .

  6 month after intervention

Secondary Outcomes (5)

• MLHFQ Questionnaire

  6 month after intervention

• 6 minute walk test ( 6MWT )

  6 month after intervention

• VO2 max

  6 month after intervention

• NT-proBNP

  6 month after intervention

• non-invasive measurement of central blood pressure

  6 month after intervention

Study Arms (1)

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 ) .

Other: expert system development

Interventions

expert system development OTHER

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 .

Also known as: System that can predict response to a personalized treatment

expert system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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 .

Sponsors & Collaborators

• University Hospital, Caen: lead

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Eric SE Saloux, MD

  CHU CAEN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2016
• First Posted: April 11, 2016
• Study Start: November 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2017
• Last Updated: April 11, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share