Status:
UNKNOWN
Protective Monocytes and Macrophages to Limit Decompensation and Heart Damaging
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Institute of Cardiometabolism and Nutrition, France
Conditions:
Left Ventricular Hypertrophy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The working hypothesis is that cardiac macrophages specific for the compensated cardiac hypertrophic phase limit the progression toward the decompensated state of heart failure by promoting an inflamm...
Detailed Description
Left ventricular hypertrophy (LVH) occurs following acute and chronic phases of ischemic heart disease as well as during pressure and/or volume overload (arterial hypertension, valvular heart disease)...
Eligibility Criteria
Inclusion
- Older than 18 years
- Patients affiliated to a social security regimen
- Informed signed consent
- Group 1 : compensated
- • Symptomatic patients with severe aortic valve stenosis associated with asymmetric septal hypertrophy or patients with hypertrophic obstructive cardiomyopathy (HOCM), with echocardiographic transvalvular gradient ≥ 40 mmHg associated with echocardiographic septal/posterior wall thickness ≥ 1.3 ejection fraction ≥ 50%, planned for aortic valve replacement with septal myomectomy or septal myomectomy for HOCM
- Group 2 : transition • Symptomatic patients with severe aortic valve stenosis associated with asymmetric septal hypertrophy or patients with hypertrophic obstructive cardiomyopathy (HOCM), with echocardiographic transvalvular gradient ≥ 40 mmHg associated with echocardiographic septal/posterior wall thickness ≥ 1.3 ejection fraction \< 50%, planned for aortic valve replacement with septal myomectomy or septal myomectomy for HOCM
- Group 3 : decompensated
- • End-stage heart failure on the waiting list for cardiac transplantation or undergoing ventricular assist device implantation as a bridge to transplantation
Exclusion
- Combined aortic valve replacement and coronary artery bypass grafting or mitral/tricuspid surgery
- Emergency operation
- Acute endocarditis
- Patient unable to give his consent
- Patient deprived of freedom or under legal protection (guardianship or curatorship)
- Pregnant or breastfeeding woman
Key Trial Info
Start Date :
October 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 15 2024
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04022330
Start Date
October 15 2019
End Date
April 15 2024
Last Update
July 25 2019
Active Locations (1)
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1
Pitié Salpêtrière Hospital
Paris, France, 75013