Clinical trial: Protective Monocytes and Macrophages to Limit Decompensation and Heart Damaging (NCT04022330)

Eligibility criteria:
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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 23-year-old man comes to the emergency department following an episode of syncope.  He was working out when he felt dizzy and passed out without head injury.  He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions.  The patient does not use tobacco, alcohol, or illicit drugs.  His father died suddenly at age 35.  Vital signs are within normal limits.  On physical examination, the patient has a harsh systolic murmur.  The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy.

Patient description (patient's own words): I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average.

Does the patient match the trial criteria? 1