Left Ventricular Hypertrophy Clinical Trial
— PROMOMAOfficial title:
Protective Gr1low Monocytes and Macrophages in Compensated Cardiac Hypertrophy to Limit Decompensation and Heart Damaging
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 inflammatory environment favouring cardiomyocyte survival and preservation of the pump function. The investigators will perform studies in human plasma and monos, cardiac tissues and macrophages to validate this hypothesis.
Status | Not yet recruiting |
Enrollment | 75 |
Est. completion date | April 15, 2024 |
Est. primary completion date | April 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
France | Pitié Salpêtrière Hospital | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | Institute of Cardiometabolism and Nutrition, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Identification of the complete spectrum of expressed mRNA of cardiac tissue macrophages. | This complete mRNA profile obtained in patients will be compared to the one found in preclinical studies in mice. The genes that are expressed during compensated cardiac hypertrophy in both human and mouse will be sorted out. The expression of the latter genes will be correlated to the cardiac pump function in order to select in the macrophage transcriptome potential markers of compensated cardiac hypertrophy. The presence of these specific macrophage markers will be investigated on frozen cardiac tissue sections by immune-histochemistry and by real time polymerase chain reaction (rtPCR). | 18 months from start date | |
Secondary | Identification of the complete transcriptome (including surface markers) of circulating monocytes from the blood collected for this project | The transcriptome of circulating monocytes will be identified by mRNA sequencing. This complete mRNA profile obtained in patients will be compared to the one found in preclinical studies in mice and the genes that are expressed during compensated cardiac hypertrophy in both human and mouse will be sorted out. The expression of the latter genes will be correlated to the cardiac pump function in order to select in the circulating monocyte transcriptome potential markers of compensated cardiac hypertrophy. The presence of these specific circulating monocyte markers will be investigated by rtPCR. | 24 months from start date | |
Secondary | Determination of the plasmatic factors in correlation with cardiac macrophage that may be specific for the compensated or decompensated state of left ventricular hypertrophy | Assessment of the presence of plasmatic factors: Based on preclinical studies showing circulating plasmatic markers of the compensated cardiac hypertrophic state, the same biomarkers will be assessed in plasma of the patients by ELISA. The concentration of these plasmatic factors will be correlated to the cardiac pump function in order to select potential markers of compensated cardiac hypertrophy. | 24 months from start date | |
Secondary | mRNA of the circulating monocytes | Characterization of mRNA of the circulating monocytes that in correlation with those of cardiac tissue macrophages may be specific for the compensated or decompensated state of left ventricular hypertrophy and thus protective against transition to heart failure. | 24 months from start date |
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